The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study
Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02676466
Collaborator
National Institute on Aging (NIA) (NIH), Abbott (Industry)
289
5
8
25.9
57.8
2.2
Study Details
Study Description
Brief Summary
ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Growing evidence shows that low-grade chronic inflammation, characterized by elevations in plasma C-reactive protein, tumor necrosis factor alpha, and particularly Interleukin-6 (IL-6), is an independent risk factor of disability, impaired mobility, and lower walking speed. Low-grade chronic inflammation is a modifiable risk factor. However, it is unknown whether interventions that reduce the levels of inflammatory markers per se improve mobility, or avert decline in mobility in older persons.
To address this gap in evidence the investigators are conducting the randomized clinical trial ENRGISE (ENabling Reduction of low-Grade Inflammation in SEniors) Pilot Study to test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability. We have maximized the public health impact by selecting interventions that are safe, tolerable, acceptable, and affordable for vulnerable older persons. Specifically, in this trial the investigators test the efficacy verus placebo of the angiotensin receptor blocker losartan and omega-3 polyunsaturated fatty acids in the form of fish oil, alone and in combination. Both angiotensin receptor blockers and omega-3 polyunsaturated fatty acids have shown to reduce IL-6 in clinical trials and preliminary data suggest that they may improve physical function.
Recruitment will include the older persons who are at risk for, or with, mobility impairment, as measured by slow gait speed and self-reported mobility difficulty, and who have elevated levels of IL-6, the marker most consistently associated with mobility limitations. Preliminary data regarding feasibility need to be gathered before such a trial can be effectively designed and implemented. We conduct The ENRGISE Pilot Study to assess the effects of the interventions on several inflammatory markers, walking speed, physical function and strength. This allows us to refine the design, recruitment yields, target population, adherence, retention, tolerability, sample-size, and cost for the main ENRGISE trial.
Study Design
Study Type:
Interventional
Actual Enrollment
:
289 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study
Actual Study Start Date
:
Apr 26, 2016
Actual Primary Completion Date
:
Jun 22, 2018
Actual Study Completion Date
:
Jun 22, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fish oil Active This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. |
Dietary Supplement: Omega-3 fish oil
The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
| Placebo Comparator: Fish oil Placebo This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. |
Other: Corn Oil (Fish oil Placebo)
The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Other Names:
|
| Active Comparator: Losartan Active This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. |
Drug: Losartan
The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
Other Names:
|
| Placebo Comparator: Losartan Placebo This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. |
Other: Cellulose Based (Losartan Placebo)
The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
Other Names:
|
| Active Comparator: Fish oil Active + Losartan Active This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. |
Dietary Supplement: Omega-3 fish oil
The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
Drug: Losartan
The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
Other Names:
|
| Other: Fish oil Active + Losartan Placebo This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. |
Dietary Supplement: Omega-3 fish oil
The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
Other: Cellulose Based (Losartan Placebo)
The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
Other Names:
|
| Other: Fish oil Placebo + Losartan Active This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. |
Drug: Losartan
The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
Other Names:
Other: Corn Oil (Fish oil Placebo)
The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Other Names:
|
| Other: Fish oil Placebo + Losartan Placebo This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. |
Other: Corn Oil (Fish oil Placebo)
The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Other Names:
Other: Cellulose Based (Losartan Placebo)
The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Changes in the Interleukin-6 Level Between Groups [Changes from baseline to month 12]
Changes in the Interleukin-6 Level Between the Groups
- Number of Participants Experiencing Major Mobility Disability [12 months]
The 400 meter walk test at usual pace is used to evaluate major mobility disability (MMD), defined as the inability to walk ¼ mile or 400 meters.
Secondary Outcome Measures
- Short Physical Performance Battery (SPPB) [12 months]
A low score on the SPPB based on 4 m walk, balance & chair stands tests is a risk factor for disability, institutionalization, morbidity and mortality in initially non-disabled older persons. The summary score and components of the SPPB have good reliability (ICCs range from 0.88 to 0.92). Higher scores are better. Range 0-12.
- Number of Participants Exhibiting Frailty [12 months]
Frailty will be characterized with Fried criteria developed by Fried et al. that employ self-reported exhaustion, unintentional weight loss, low energy expenditure, slow gait speed, and weak grip strength. Those with >3 of the 5 factors are judged to be frail, those with 1 or 2 factors as pre-frail, and those with no factors as non-frail.
- Isometric Hand Grip Strength [12 months]
The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. Scoring will be taken from the best results of 3 trials. Males scores range from 88 pounds as very poor to 141 pounds as excellent with an average of 105-113 pounds. Females scores range from 44 pounds as very poor to 84 pounds as excellent with an average of 57-65 pounds.
- Peak Torque of the Knee Extensor and Flexor Muscles [month 12]
Peak torque was measured at a rotational speed of 60 degrees per second using a commercially-available Isokinetic Dynamometer (Biodex). Torque was measured during maximal knee extension and flexion reported in Newton Meters.
- Short Form Health Survey (SF-36) - Physical Component Score [month 12]
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Range: 0-100. A lower score indicates more disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Eligibility Criteria
Criteria
Ages Eligible for Study:
70 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Men and women age >70 years
-
Self-reported difficulty walking ¼ of a mile or climbing a flight of stairs
-
Walking speed <1 meters per second and >0.44 meters per second on the 4 meter walk at usual pace. A walking speed of <0.44 meters per second would not be compatible with completing the 400 meter walk in 15 minutes. (In the pilot phase we explore the feasibility of recruiting at least 50% of participants who have a baseline walking speed of <0.80 meters per second and >0.44 meters per second)
-
Able to complete the 400 meter walk test within 15 minutes without sitting or the help of another person and without a walker, a cane is allowed
-
Blood level IL-6 >2.5 pg/ml and <30 pg/ml.
-
Willingness to be randomized to the intervention groups
Exclusion Criteria:
-
Failure or inability to provide informed consent
-
Lives in a nursing home; persons living in assisted or independent housing are not excluded
-
Self-reported inability to walk one block
-
Significant cognitive impairment, defined as a known diagnosis of dementia, or a Mini-Mental State Exam (MMSE) score <24 (<23 for racial/ethnic minorities or participants with less than 9 years of education)
-
Unable to communicate because of severe hearing loss or speech disorder
-
Neurological conditions that are causing impaired muscle function or mobility (may include stroke with residual paresis, paralysis, neuropathy, Parkinson disease, or multiple sclerosis)
-
Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, known active inflammatory or autoimmune disease (e.g. rheumatoid arthritis, lupus, Crohn's disease, HIV)
-
Terminal illness with life expectancy less than 12 months
-
Severe pulmonary disease, requiring either steroid pills or injections
-
Other significant co-morbid disease that in the opinion of the field center PI would impair ability to participate in the trial, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia), excessive alcohol use (>14 drinks per week); drug addiction; treatment for cancer (radiation or chemotherapy) within the past 1 year; or other conditions
-
Lives outside of the study site or is planning to move out of the area in next 1 year or leave the area for >3 months during the next year
-
Exclusion criteria that apply only to those who receive losartan:
-
Intolerance or allergy to Angiotensin II Receptor Blockers (ARBs)
-
Known bilateral renal artery stenosis or liver cirrhosis
-
Hypotension Systolic Blood Pressure<110 or Diastolic Blood Pressure<60 mmHg
-
Serum potassium ≥5.0 mEq/L
-
Use of lithium salts
-
eGFR <15
-
Congestive heart failure with ejection fraction < 40%
-
Exclusion criteria that apply only to those who receive ω-3:
-
Intolerance or allergy to ω-3 or fish/shellfish
-
Fatty fish intake >2 servings per week on average
-
History of paroxysmal or persistent atrial fibrillation
-
To maintain blinding, those who are not eligible to receive any active treatment (ω-3 or losartan) are excluded
Temporary exclusion criteria
-
Myocardial infarction, coronary artery bypass grafting (CABG), or valve replacement within past 6 months;
-
Pulmonary embolism or deep venous thrombosis within past 6 months;
-
Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
-
Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months;
-
Physical therapy for gait, balance, or other lower extremity training within the past 2 months;
-
Severe hypertension, e.g., Systolic Blood Pressure > 200, or Diastolic Blood Pressure> 110 mmHg;
-
Hemoglobin <10 g/dL
-
Participation in another intervention trial within 3 months; participation in an observational study may be permitted;
-
Current smoking (within 6 months),
-
Acute infection (urinary, respiratory, other) or hospitalization within 1 month
-
Exclusion criteria that apply only to those who receive losartan:
-
Use of Angiotensin-Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) within 2 months
-
Use of aliskiren within 2 months in patients with type 2 diabetes or renal impairment with Estimated Glomerular Filtration Rate (eGFR)<60
-
Use of potassium sparing diuretics, other medications with potassium sparing properties (such as but not limited to spironolactone or eplerenone) potassium supplements, and salt substitutes containing potassium within 1 week
-
Transaminases >twice upper limit of normal to exclude participants with impaired liver function
-
Exclusion criteria that apply only to those who receive ω-3:
-
Use of ω-3 within 2 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida | Gainesville | Florida | United States | 32611 |
| 2 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 3 | Tufts University | Boston | Massachusetts | United States | 02111 |
| 4 | Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
| 5 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Florida
- National Institute on Aging (NIA)
- Abbott
Investigators
- Principal Investigator: Marco Pahor, MD, University of Florida
- Principal Investigator: Walter Ambrosius, PhD, Wake Forest University
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT02676466
Other Study ID Numbers:
- IRB201500894 - A-N
- U01AG050499
First Posted:
Feb 8, 2016
Last Update Posted:
Dec 12, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Florida
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. | This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. | This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six months. | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. | This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. |
| Period Title: Overall Study | ||||||||
| STARTED | 109 | 71 | 26 | 17 | 26 | 13 | 13 | 14 |
| COMPLETED | 105 | 66 | 24 | 17 | 23 | 12 | 12 | 13 |
| NOT COMPLETED | 4 | 5 | 2 | 0 | 3 | 1 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. | This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. | This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. Cellulose Based (Losartan Placeb | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams /day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure | This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | Total of all reporting groups |
| Overall Participants | 109 | 71 | 26 | 17 | 26 | 13 | 13 | 14 | 289 |
| Age (Count of Participants) | |||||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
109
100%
|
71
100%
|
26
100%
|
17
100%
|
26
100%
|
13
100%
|
13
100%
|
14
100%
|
289
100%
|
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
78
(5)
|
77
(5)
|
78
(5)
|
77
(6)
|
77
(6)
|
79
(7)
|
76
(5)
|
78
(5)
|
78
(5)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
58
53.2%
|
37
52.1%
|
15
57.7%
|
12
70.6%
|
14
53.8%
|
6
46.2%
|
6
46.2%
|
4
28.6%
|
152
52.6%
|
| Male |
51
46.8%
|
34
47.9%
|
11
42.3%
|
5
29.4%
|
12
46.2%
|
7
53.8%
|
7
53.8%
|
10
71.4%
|
137
47.4%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||||||
| Minority (non-white only),self-report |
24
22%
|
14
19.7%
|
9
34.6%
|
3
17.6%
|
4
15.4%
|
3
23.1%
|
3
23.1%
|
4
28.6%
|
64
22.1%
|
| Region of Enrollment (participants) [Number] | |||||||||
| United States |
109
100%
|
71
100%
|
26
100%
|
17
100%
|
26
100%
|
13
100%
|
13
100%
|
14
100%
|
289
100%
|
| IL-6 (pg/ml) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [pg/ml] |
3.7
(1.5)
|
4.4
(1.7)
|
3.5
(1.3)
|
5.7
(3.7)
|
2.8
(1.6)
|
3.1
(1.4)
|
4.3
(1.2)
|
4.2
(1.6)
|
3.9
(1.7)
|
Outcome Measures
| Title | Changes in the Interleukin-6 Level Between Groups |
|---|---|
| Description | Changes in the Interleukin-6 Level Between the Groups |
| Time Frame | Changes from baseline to month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. | This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. | This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams/day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. Cellulose Based (Losartan Placeb | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams/day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure | This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. |
| Measure Participants | 109 | 71 | 26 | 17 | 26 | 13 | 13 | 14 |
| Mean (Standard Deviation) [pg/ml] |
0
(2.4)
|
-0.1
(2.7)
|
-0.6
(1.0)
|
3.8
(10.0)
|
-0.3
(1.0)
|
-0.2
(1.8)
|
-1.4
(0.9)
|
-1.0
(2.8)
|
| Title | Number of Participants Experiencing Major Mobility Disability |
|---|---|
| Description | The 400 meter walk test at usual pace is used to evaluate major mobility disability (MMD), defined as the inability to walk ¼ mile or 400 meters. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. | This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. | This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams/ day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams/day or be increased to 2.8 grams per day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. Cellulose Based (Losartan Placeb | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams/day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure | This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. |
| Measure Participants | 109 | 71 | 26 | 17 | 26 | 13 | 13 | 14 |
| Count of Participants [Participants] |
20
18.3%
|
5
7%
|
4
15.4%
|
15
88.2%
|
4
15.4%
|
3
23.1%
|
7
53.8%
|
3
21.4%
|
| Title | Short Physical Performance Battery (SPPB) |
|---|---|
| Description | A low score on the SPPB based on 4 m walk, balance & chair stands tests is a risk factor for disability, institutionalization, morbidity and mortality in initially non-disabled older persons. The summary score and components of the SPPB have good reliability (ICCs range from 0.88 to 0.92). Higher scores are better. Range 0-12. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. | This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. | This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. Cellulose Based (Losartan Placeb | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams /day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure | This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. |
| Measure Participants | 109 | 71 | 26 | 17 | 26 | 13 | 13 | 14 |
| Mean (Standard Deviation) [units on a scale] |
8.6
(2.3)
|
8.1
(2.5)
|
8.2
(2.5)
|
8.4
(2.7)
|
8.6
(2.5)
|
7.3
(2.1)
|
8.5
(2.1)
|
9.1
(2.0)
|
| Title | Number of Participants Exhibiting Frailty |
|---|---|
| Description | Frailty will be characterized with Fried criteria developed by Fried et al. that employ self-reported exhaustion, unintentional weight loss, low energy expenditure, slow gait speed, and weak grip strength. Those with >3 of the 5 factors are judged to be frail, those with 1 or 2 factors as pre-frail, and those with no factors as non-frail. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. | This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. | This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. Cellulose Based (Losartan Placeb | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams /day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure | This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. |
| Measure Participants | 109 | 71 | 26 | 17 | 26 | 13 | 13 | 14 |
| Count of Participants [Participants] |
15
13.8%
|
3
4.2%
|
4
15.4%
|
1
5.9%
|
3
11.5%
|
3
23.1%
|
1
7.7%
|
1
7.1%
|
| Title | Isometric Hand Grip Strength |
|---|---|
| Description | The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. Scoring will be taken from the best results of 3 trials. Males scores range from 88 pounds as very poor to 141 pounds as excellent with an average of 105-113 pounds. Females scores range from 44 pounds as very poor to 84 pounds as excellent with an average of 57-65 pounds. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. | This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. | This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. Cellulose Based (Losartan Placeb | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams /day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure | This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. |
| Measure Participants | 109 | 71 | 26 | 17 | 26 | 13 | 13 | 14 |
| Mean (Standard Deviation) [pounds] |
24.8
(8.5)
|
25.3
(7.3)
|
25.9
(9.2)
|
27.5
(11.0)
|
22.4
(9.5)
|
19.8
(8.7)
|
27.6
(8.4)
|
23.6
(10.1)
|
| Title | Peak Torque of the Knee Extensor and Flexor Muscles |
|---|---|
| Description | Peak torque was measured at a rotational speed of 60 degrees per second using a commercially-available Isokinetic Dynamometer (Biodex). Torque was measured during maximal knee extension and flexion reported in Newton Meters. |
| Time Frame | month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. | This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. | This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. Cellulose Based (Losartan Placeb | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams /day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure | This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. |
| Measure Participants | 109 | 71 | 26 | 17 | 26 | 13 | 13 | 14 |
| Mean (Standard Deviation) [Newton meters] |
81.3
(34.0)
|
77.7
(30.8)
|
87.6
(35.5)
|
78.6
(28.6)
|
85.3
(29.8)
|
76.6
(19.2)
|
84.0
(52.8)
|
86.1
(24.5)
|
| Title | Short Form Health Survey (SF-36) - Physical Component Score |
|---|---|
| Description | The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Range: 0-100. A lower score indicates more disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
| Time Frame | month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. | This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. | This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screenin | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. Cellulose Based (Losartan Placeb | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams /day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure | This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. |
| Measure Participants | 109 | 71 | 26 | 17 | 26 | 13 | 13 | 14 |
| Mean (Standard Deviation) [score on a scale] |
41.9
(7.9)
|
42.6
(9.7)
|
41.8
(9.8)
|
41.3
(9.0)
|
41.9
(8.6)
|
42.7
(8.2)
|
46.6
(7.4)
|
47.9
(6.7)
|
Adverse Events
| Time Frame | Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months. | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months. | |||||||||||||||
| Arm/Group Title | Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo | ||||||||
| Arm/Group Description | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil. | This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day. | This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules. | This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six months. | This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month. In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan. | This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil. In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months. | This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study. | ||||||||
All Cause Mortality |
||||||||||||||||
| Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/109 (0%) | 2/71 (2.8%) | 1/26 (3.8%) | 0/17 (0%) | 0/26 (0%) | 0/13 (0%) | 0/13 (0%) | 0/14 (0%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 30/109 (27.5%) | 17/71 (23.9%) | 3/26 (11.5%) | 4/17 (23.5%) | 8/26 (30.8%) | 3/13 (23.1%) | 2/13 (15.4%) | 5/14 (35.7%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| ACUTE CORONARY SYNDROME | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| AORTIC VALVE DISEASE | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| ATRIAL FIBRILLATION | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| CARDIAC ARREST | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| CARDIAC DISORDERS - OTHER, SPECIFY | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| CHEST PAIN - CARDIAC | 3/109 (2.8%) | 3 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HEART FAILURE | 0/109 (0%) | 0 | 2/71 (2.8%) | 2 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| MYOCARDIAL INFARCTION | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 1/26 (3.8%) | 1 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| SICK SINUS SYNDROME | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| SINUS BRADYCARDIA | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| CARDIAC ARREST | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HEART FAILURE | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| MYOCARDIAL INFARCTION | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 1/26 (3.8%) | 1 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| ACUTE CORONARY SYNDROME | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| AORTIC VALVE DISEASE | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| ATRIAL FIBRILLATION | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| CARDIAC DISORDERS - OTHER, SPECIFY | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| CHEST PAIN - CARDIAC | 3/109 (2.8%) | 3 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HEART FAILURE | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| MYOCARDIAL INFARCTION | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| SICK SINUS SYNDROME | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| SINUS BRADYCARDIA | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||
| COLONIC HEMORRHAGE | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| ESOPHAGEAL OBSTRUCTION | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| SMALL INTESTINAL OBSTRUCTION | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| COLONIC HEMORRHAGE | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| ESOPHAGEAL OBSTRUCTION | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| SMALL INTESTINAL OBSTRUCTION | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| General disorders | ||||||||||||||||
| NON-CARDIAC CHEST PAIN | 1/109 (0.9%) | 1 | 2/71 (2.8%) | 2 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| NON-CARDIAC CHEST PAIN | 1/109 (0.9%) | 1 | 2/71 (2.8%) | 2 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| Hepatobiliary disorders | ||||||||||||||||
| HEPATIC FAILURE | 0/109 (0%) | 0 | 1/71 (1.4%) | 2 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HEPATIC FAILURE | 0/109 (0%) | 0 | 1/71 (1.4%) | 2 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Infections and infestations | ||||||||||||||||
| BRONCHIAL INFECTION | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 2/26 (7.7%) | 2 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| LUNG INFECTION | 2/109 (1.8%) | 2 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| SKIN INFECTION | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| UPPER RESPIRATORY INFECTION | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| URINARY TRACT INFECTION | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| BRONCHIAL INFECTION | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 2/26 (7.7%) | 2 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| LUNG INFECTION | 2/109 (1.8%) | 2 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| SKIN INFECTION | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| UPPER RESPIRATORY INFECTION | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| URINARY TRACT INFECTION | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||
| FALL | 1/109 (0.9%) | 1 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| FRACTURE | 3/109 (2.8%) | 3 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HIP FRACTURE | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 1/14 (7.1%) | 1 |
| FALL | 1/109 (0.9%) | 1 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| FRACTURE | 3/109 (2.8%) | 3 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HIP FRACTURE | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 1/14 (7.1%) | 1 |
| Metabolism and nutrition disorders | ||||||||||||||||
| DEHYDRATION | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HYPERGLYCEMIA | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| DEHYDRATION | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HYPERGLYCEMIA | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| ARTHRITIS | 3/109 (2.8%) | 4 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 1/17 (5.9%) | 1 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| BACK PAIN | 2/109 (1.8%) | 3 | 0/71 (0%) | 0 | 1/26 (3.8%) | 1 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| JOINT RANGE OF MOTION DECREASED LUMBAR SPINE | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| PAIN IN EXTREMITY | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| ARTHRITIS | 3/109 (2.8%) | 4 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 1/17 (5.9%) | 1 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| BACK PAIN | 2/109 (1.8%) | 3 | 0/71 (0%) | 0 | 1/26 (3.8%) | 1 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| JOINT RANGE OF MOTION DECREASED LUMBAR SPINE | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| PAIN IN EXTREMITY | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | 1/109 (0.9%) | 1 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | 1/109 (0.9%) | 1 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||
| AMNESIA | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 1/17 (5.9%) | 1 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| DIZZINESS | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 1/26 (3.8%) | 1 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| INTRACRANIAL HEMORRHAGE | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 0/14 (0%) | 0 |
| ORTHOPEDIC NEUROLOGIC | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| PERIPHERAL MOTOR NEUROPATHY | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| STROKE | 2/109 (1.8%) | 2 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 0/14 (0%) | 0 |
| SYNCOPE | 1/109 (0.9%) | 1 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| TRANSIENT ISCHEMIC ATTACKS | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| TREMOR | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| AMNESIA | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 1/17 (5.9%) | 1 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| DIZZINESS | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 1/26 (3.8%) | 1 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| INTRACRANIAL HEMORRHAGE | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 0/14 (0%) | 0 |
| ORTHOPEDIC NEUROLOGIC | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| PERIPHERAL MOTOR NEUROPATHY | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| STROKE | 2/109 (1.8%) | 2 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 0/14 (0%) | 0 |
| SYNCOPE | 1/109 (0.9%) | 1 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| TRANSIENT ISCHEMIC ATTACKS | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| TREMOR | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||
| ACUTE KIDNEY INJURY | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| RENAL AND URINARY DISORDERS - OTHER, SPECIFY | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| RENAL CALCULI | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| URINARY TRACT OBSTRUCTION | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 1/17 (5.9%) | 1 | 0/26 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| ACUTE KIDNEY INJURY | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| RENAL AND URINARY DISORDERS - OTHER, SPECIFY | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| RENAL CALCULI | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| URINARY TRACT OBSTRUCTION | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 1/17 (5.9%) | 1 | 0/26 (0%) | 0 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| COUGH | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| RESPIRATORY FAILURE | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| COUGH | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| RESPIRATORY FAILURE | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| SCALP PAIN | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| SCALP PAIN | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Surgical and medical procedures | ||||||||||||||||
| SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY | 1/109 (0.9%) | 1 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 1/17 (5.9%) | 1 | 2/26 (7.7%) | 2 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| SURGICAL AND MEDICAL PROCEDURES, OTHER, LEFT KNEE REPLACEMENT | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY | 1/109 (0.9%) | 1 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 1/17 (5.9%) | 1 | 2/26 (7.7%) | 2 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| SURGICAL AND MEDICAL PROCEDURES, OTHER, LEFT KNEE REPLACEMENT | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| Vascular disorders | ||||||||||||||||
| HEMATOMA | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HYPOTENSION | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| THROMBOEMBOLIC EVENT | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HEMATOMA | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| HYPOTENSION | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| THROMBOEMBOLIC EVENT | 1/109 (0.9%) | 1 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 1/26 (3.8%) | 1 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Fish Oil Active | Fish Oil Placebo | Losartan Active | Losartan Placebo | Fish Oil Active + Losartan Active | Fish Oil Active + Losartan Placebo | Fish Oil Placebo + Losartan Active | Fish Oil Placebo + Losartan Placebo | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 73/109 (67%) | 46/71 (64.8%) | 22/26 (84.6%) | 16/17 (94.1%) | 20/26 (76.9%) | 12/13 (92.3%) | 10/13 (76.9%) | 11/14 (78.6%) | ||||||||
| General disorders | ||||||||||||||||
| NON-SERIOUS AES - Any Adverse Event | 73/109 (67%) | 166 | 46/71 (64.8%) | 97 | 22/26 (84.6%) | 74 | 16/17 (94.1%) | 35 | 20/26 (76.9%) | 46 | 12/13 (92.3%) | 34 | 10/13 (76.9%) | 21 | 11/14 (78.6%) | 34 |
| NON-SERIOUS AES - Atrial Fibrillation | 0/109 (0%) | 0 | 2/71 (2.8%) | 2 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NON-SERIOUS AES - Cough | 4/109 (3.7%) | 4 | 3/71 (4.2%) | 4 | 0/26 (0%) | 0 | 2/17 (11.8%) | 2 | 3/26 (11.5%) | 3 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 2/14 (14.3%) | 2 |
| NON-SERIOUS AES - Dizziness/Presyncope | 1/109 (0.9%) | 1 | 1/71 (1.4%) | 1 | 6/26 (23.1%) | 6 | 4/17 (23.5%) | 4 | 5/26 (19.2%) | 6 | 2/13 (15.4%) | 2 | 5/13 (38.5%) | 5 | 2/14 (14.3%) | 3 |
| NON-SERIOUS AES - Fall (mechanical) | 10/109 (9.2%) | 10 | 7/71 (9.9%) | 7 | 1/26 (3.8%) | 1 | 3/17 (17.6%) | 4 | 2/26 (7.7%) | 4 | 4/13 (30.8%) | 5 | 0/13 (0%) | 0 | 2/14 (14.3%) | 3 |
| NON-SERIOUS AES - Fatigue | 2/109 (1.8%) | 2 | 3/71 (4.2%) | 4 | 2/26 (7.7%) | 2 | 0/17 (0%) | 0 | 2/26 (7.7%) | 2 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 2/14 (14.3%) | 2 |
| NON-SERIOUS AES - Syncope | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NON-SERIOUS AES - GI Upset | 7/109 (6.4%) | 7 | 5/71 (7%) | 5 | 1/26 (3.8%) | 1 | 1/17 (5.9%) | 1 | 3/26 (11.5%) | 4 | 1/13 (7.7%) | 1 | 0/13 (0%) | 0 | 2/14 (14.3%) | 2 |
| NON-SERIOUS AES - Hyperglycemia | 1/109 (0.9%) | 1 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NON-SERIOUS AES - Hyperkalemia | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 1/26 (3.8%) | 1 | 1/17 (5.9%) | 1 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 1/14 (7.1%) | 1 |
| NON-SERIOUS AES - Severe Hyperglycemic Episode | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NON-SERIOUS AES - Drop in hemoglobin | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NON-SERIOUS AES - Hypotension | 6/109 (5.5%) | 6 | 2/71 (2.8%) | 2 | 1/26 (3.8%) | 1 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NON-SERIOUS AES - Drop in eGFR | 0/109 (0%) | 0 | 1/71 (1.4%) | 1 | 2/26 (7.7%) | 2 | 3/17 (17.6%) | 3 | 1/26 (3.8%) | 1 | 2/13 (15.4%) | 2 | 1/13 (7.7%) | 1 | 1/14 (7.1%) | 1 |
| NON-SERIOUS AES - Acute Renal Failure | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NON-SERIOUS AES - Angiodema | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NON-SERIOUS AES - Stroke or TIA | 0/109 (0%) | 0 | 0/71 (0%) | 0 | 0/26 (0%) | 0 | 0/17 (0%) | 0 | 0/26 (0%) | 0 | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/14 (0%) | 0 |
| NON-SERIOUS AES - Other | 69/109 (63.3%) | 144 | 40/71 (56.3%) | 80 | 20/26 (76.9%) | 64 | 15/17 (88.2%) | 26 | 19/26 (73.1%) | 32 | 10/13 (76.9%) | 27 | 7/13 (53.8%) | 15 | 11/14 (78.6%) | 29 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | ENRGISE Coordinating Center Project Manager |
|---|---|
| Organization | University of Florida |
| Phone | 352-294-5800 |
| ENGISEACC@aging.ufl.edu |
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT02676466
Other Study ID Numbers:
- IRB201500894 - A-N
- U01AG050499
First Posted:
Feb 8, 2016
Last Update Posted:
Dec 12, 2019
Last Verified:
Dec 1, 2019