This trial is active, not recruiting.

Condition metabolic syndrome x
Treatment omega-3 fatty acids
Phase phase 0
Sponsor University of Washington
Collaborator Pfizer
Start date October 2006
End date October 2011
Trial size 100 participants
Trial identifier NCT00350194, 05-8693-D 03, 28791-D


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
(Placebo Comparator)
Omega-3 fatty acid vs. placebo comparator
omega-3 fatty acids Fish Oil
Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)

Primary Outcomes

Change in Carotid IMT
time frame: 1 year, 2 years

Secondary Outcomes

Lipid (apolipoproteins and lipid parameters)
time frame: 1 year, 2 years
hs-CRP & SAA
time frame: 1 year, 2 years
time frame: 1 year, 2 years
time frame: 1 year, 2 years
time frame: 1 year, 2 years
urine microalbumin/creatinine
time frame: 1 year, 2 years
Serum Fatty Acids
time frame: 1 year, 2 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Principal investigator Pathmaja Paramsothy, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by University of Washington.