The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

University of Washington

Status and phase

Unknown

Early Phase 1

Conditions

Metabolic Syndrome X

Treatments

Dietary Supplement: Omega-3 fatty acids

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00350194

28791-D

05-8693-D 03

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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