The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

Status unconfirmed · Early Phase 1

Conditions studied: Metabolic Syndrome X

In brief

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.

Key facts

Study ID

NCT00350194

Run by

University of Washington

People needed

100

Starts

2006-10-01

Expected to finish

2012-06-01

Last updated by the study team

2012-03-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwest Lipid Research Clinic (University of Washington Affiliated) — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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