The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

NCT ID: NCT00350194

Last Updated: 2012-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2012-06-30

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.

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.

Conditions

Metabolic Syndrome X

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Omega-3 fatty acid vs. placebo comparator

Group Type: PLACEBO_COMPARATOR

Omega-3 fatty acids

Intervention Type: DIETARY_SUPPLEMENT

Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)

Interventions

Omega-3 fatty acids

Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Fish Oil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Northwest Lipid Research Clinic

UNKNOWN

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Pathmaja Paramsothy

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pathmaja Paramsothy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Northwest Lipid Research Clinic (University of Washington Affiliated)

Seattle, Washington, United States

Countries

United States

Other Identifiers

05-8693-D 03

Identifier Type: -

Identifier Source: secondary_id

28791-D

Identifier Type: -

Identifier Source: org_study_id