The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

Early Phase 1

• Conditions: Metabolic Syndrome X
• Interventions: Dietary Supplement: Omega-3 fatty acids

• Registration Number: NCT00350194
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-10
• Study Start: 2006-10
• Primary Completion: 2011-10
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-29
• Last Update Posted: 2012-03-02
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Omega-3 fatty acids	Omega-3 fatty acid vs. placebo comparator

Primary Outcome Measures

Name	Time	Method
Change in Carotid IMT	1 year, 2 years

Secondary Outcome Measures

Name	Time	Method
Insulin	1 year, 2 years
adiponectin	1 year, 2 years
urine microalbumin/creatinine	1 year, 2 years
Serum Fatty Acids	1 year, 2 years
Lipid (apolipoproteins and lipid parameters)	1 year, 2 years
hs-CRP & SAA	1 year, 2 years
Glucose	1 year, 2 years

Trial Locations

Locations (1)

Northwest Lipid Research Clinic (University of Washington Affiliated); 🇺🇸 Seattle, Washington, United States