Oxi-Stress: Oxidative Stress and Nutritional Supplementation Intervention Study

Sponsor

University of Saskatchewan (Other)

Overall Status

Completed

CT.gov ID

NCT01234506

Collaborator

Saskatchewan Health Research Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A major means whereby oxidative stress promotes aging-related disease is by activating inflammatory pathways. Decreasing oxidative stress and inflammation should ameliorate many of the problems associated with aging, including vascular dementia, Alzheimer's disease, osteoporosis, muscle wasting, insulin resistance, type 2 diabetes, and metabolic syndrome. Animal and human studies have demonstrated that consumption of vitamin D and phase 2 protein inducers decrease oxidative stress and associated inflammation. The flax lignan secoisolariciresinol diglucoside (SDG) is metabolized to enterolactone, a potent phase 2 protein inducer. Animal and human studies have shown that consumption of flax seed or its component SDG decreases hypertension, serum cholesterol, atherosclerosis, the growth of experimentally-induced cancers as well as metastases of human breast tumours implanted into nude mice, and delays the development of type 2 diabetes. Vitamin D plays a role in modulating inflammation, enhancing immunity (while suppressing autoimmune injury) and exerting control over cell differentiation. Adequate levels of vitamin D also appear to promote better glycemic control. The investigators predict that consumption of SDG in persons with adequate vitamin D status will decrease oxidative stress and associated inflammation. If this hypothesis is upheld, this research has the potential to greatly decrease healthcare costs while allowing healthier aging.

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress Inflammation Aging Dementia Pain	Dietary Supplement: secoisolariciresinol diglucoside	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Community Alliance for Quality of Life in Long Term Care: Oxidative Stress and Nutritional Supplementation Intervention Study

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: secoisolariciresinol diglucoside Secoisolariciresinol diglucoside (SDG) supplementation as 0.8g/day of BeneFlax containing 300 mg SDG. 1000 IU vitamin D as standard of care.	Dietary Supplement: secoisolariciresinol diglucoside SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks Other Names: Beneflax Flax Lignan Extract Archer Daniels Midland,#080001. Natural Factors Whey Factors whey protein (unflavored). Vitamin D NPN 80003663 WN Pharmaceuticals
Placebo Comparator: Placebo An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care.	Dietary Supplement: secoisolariciresinol diglucoside SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks Other Names: Beneflax Flax Lignan Extract Archer Daniels Midland,#080001. Natural Factors Whey Factors whey protein (unflavored). Vitamin D NPN 80003663 WN Pharmaceuticals

Arm

Intervention/Treatment

Active Comparator: secoisolariciresinol diglucoside

Secoisolariciresinol diglucoside (SDG) supplementation as 0.8g/day of BeneFlax containing 300 mg SDG. 1000 IU vitamin D as standard of care.

Dietary Supplement: secoisolariciresinol diglucoside

SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks

Other Names:

Beneflax Flax Lignan Extract Archer Daniels Midland,#080001.

Natural Factors Whey Factors whey protein (unflavored).

Vitamin D NPN 80003663 WN Pharmaceuticals

Placebo Comparator: Placebo

An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care.

Dietary Supplement: secoisolariciresinol diglucoside

SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks

Other Names:

Beneflax Flax Lignan Extract Archer Daniels Midland,#080001.

Natural Factors Whey Factors whey protein (unflavored).

Vitamin D NPN 80003663 WN Pharmaceuticals

Outcome Measures

Primary Outcome Measures

Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y) [24 weeks]
Adverse event occurrences will be compared descriptively between the SDG and placebo groups. Safety will be assessed at 0, 6, 12, 18 and 24 weeks; as part of the blood collection (urea, creatinine, total bilirubin, platelets, hematocrit, haemoglobin, mean corpuscular haemoglobin, mean corpuscular volume, white blood cell count, total protein including albumin and prealbumin, total calcium, electrolytes, glucose, liver enzymes (AST, ALT, ALP), total protein, albumin, lipids, HbA1c (for diabetic participants). Blood pressure measurements will be performed every two weeks
Effect of SDG on oxidative stress and inflammation [24 weeks]
SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in oxidative stress measurements (plasma malondialdehyde), pro-inflammatory markers (IL-6, IL-1α, IL-1β, 8-isoprostane, TNF-α, C-reactive protein).

Secondary Outcome Measures

Effect of SDG on quality of life [24 weeks]
SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in cognitive function, pain, and physical function including falls, as well as performance of activities of daily living.
Effect of SDG supplement on blood levels of flax lignan metabolites [24 weeks]
To further understand the pharmacology of SDG, we will analyze plasma levels of the SDG metabolites secoisolariciresinol, enterolactone and enterodiol in those subjects given flax lignan supplement. Levels will be determined 0, 12 and 24 weeks.
To measure effects of SDG on bone resorption [24 weeks]
SDG and placebo groups will be compared at 0 and 24 weeks for changes in bone resorption as assessed by measurement of cross-linked N-telopeptides type I collagen serum levels.
Effect of SDG on blood lipids [24 weeks]
SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in nonfasting levels of cholesterol, LDL, HDL, and triglycerides.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

adults residing in a long term care facility
resident for a minimum of four weeks prior to entry
able to comply with study protocol
able to follow simple instructions
able to give informed consent or has a legally acceptable representative who is able to provide consent

Exclusion Criteria:

Age below 60 or above 80 years.
Individuals at risk of hypotension or with symptomatic hypotension.
Fasting hypoglycemia.
Unstable diabetes
Diabetics taking insulin
Current cancer or diagnosed with cancer in the past 2 years.
Women with an immediate family history or personal history of breast cancer or ovarian cancer
Significant liver disorder
Significant gastrointestinal disorder including inflammatory bowel disease but not constipation
Significant kidney disorder
Unstable or severe cardiac disease, recent MI or stroke either in past 6 months or significantly (i.e., severely) affecting physical mobility.
Unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder.
Migraine with aura within the last year (as this is a risk factor for stroke).
Current diagnosis of a bleeding condition, or at risk of bleeding.
Significant immunocompromise.
Other unstable conditions.
Current use of hormone replacement therapy except thyroid medication
Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues.
Intolerances or allergies to flax or vitamin D.
Estimated probability of longevity of less than one year based on medical opinion