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The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

Sponsor
University of Washington (Other)
Overall Status
Unknown status
CT.gov ID
NCT00350194
Collaborator
Pfizer (Industry), National Institutes of Health (NIH) (NIH), Northwest Lipid Research Clinic (Other)
100
Enrollment
1
Location
1
Arm
68
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effects of omega-3 fatty acids in the form of fish oil supplementation (approximately 2 grams per day) on the carotid intima-media (CIMT)progression (primary objective) and 2)(Secondary objective) lipid markers such as LDL, apo-B, and LDL buoyancy, on inflammatory burden as measured by CRP, on oxidative stress as measured by urinary isoprostanes, urine microalbumin/creatinine, and serum adiponectin a fat derived hormone in subjects with metabolic syndrome.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Omega-3 fatty acids
 Early Phase 1

Detailed Description

This translational pilot study will have a double-blind, placebo-controlled, parallel design. We will enroll one hundred subjects who meet at least 3 of the 5 criteria for metabolic syndrome as per NCEP guidelines/WHO guidelines and who do not have known cardiovascular disease or diabetes. They will receive either placebo or omega-3 fatty acids in the form of fish oil capsules for a two-year period. Assessment of, C-IMT, serum lipoprotein profile, LDL- buoyancy, adiponectin, CRP, SAA, apolipoprotein B and A-1, fasting glucose, fasting insulin levels, and plasma fatty acids will be measured at baseline, one year, and two years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Pilot Study: The Effects of Omega-3 Fatty Acids on Metabolic Syndrome and Vascular Structure in Metabolic Syndrome as Assessed by Carotid IMT
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Oct 1, 2011
Anticipated Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1

Omega-3 fatty acid vs. placebo comparator

Dietary Supplement: Omega-3 fatty acids
Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)
Other Names:
  • Fish Oil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Carotid IMT [1 year, 2 years]

    Secondary Outcome Measures

    1. Lipid (apolipoproteins and lipid parameters) [1 year, 2 years]

    2. hs-CRP & SAA [1 year, 2 years]

    3. Glucose [1 year, 2 years]

    4. Insulin [1 year, 2 years]

    5. adiponectin [1 year, 2 years]

    6. urine microalbumin/creatinine [1 year, 2 years]

    7. Serum Fatty Acids [1 year, 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adults with Metabolic Syndrome (meets 3 of the following 5)

    • Abdominal obesity, waist circumference in men greater than 40 in. & in women greater than 35 in.

    • Serum triglycerides greater than or = 150 mg/dL (1.7 mmol/L)

    • Serum HDL cholesterol less than or = 40 mg/dL in men and less than 50 mg/dL in women

    • Blood pressure greater than or = 130/85 mmHg or drug treatment for elevated blood pressure

    • Fasting plasma glucose greater than 100 mg/dL

    Exclusion Criteria:

    • Diabetes

    • Known or documented CHD (including ECG consistent with prior MI), CVA (including TIA), PVD (including symptoms of claudication)

    • Angina or other chest pain that may indicate CHD

    • Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)

    • Known abnormal LFTS greater than 2X ULN

    • Smoker, illicit drug use, or excessive alcohol use

    • Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, Omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months

    • Pregnancy or planning pregnancy during the study period

    • Sensitivity or allergy to fish

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwest Lipid Research Clinic (University of Washington Affiliated) Seattle Washington United States 98104

    Sponsors and Collaborators

    • University of Washington
    • Pfizer
    • National Institutes of Health (NIH)
    • Northwest Lipid Research Clinic

    Investigators

    • Principal Investigator: Pathmaja Paramsothy, MD, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pathmaja Paramsothy, Assistant Professor of Medicine, University of Washington
    ClinicalTrials.gov Identifier:
    NCT00350194
    Other Study ID Numbers:
    • 28791-D
    • 05-8693-D 03
    First Posted:
    Jul 10, 2006
    Last Update Posted:
    Mar 2, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by Pathmaja Paramsothy, Assistant Professor of Medicine, University of Washington
    Fatty Acids, Omega-3
    Additional relevant MeSH terms:
    Metabolic Syndrome
    Syndrome

    Study Results

    No Results Posted as of Mar 2, 2012