The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

Pilot Study: The Effects of Omega-3 Fatty Acids on Metabolic Syndrome and Vascular Structure in Metabolic Syndrome as Assessed by Carotid IMT

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Dietary supplement: Omega-3 fatty acids

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Northwest Lipid Research Clinic (University of Washington Affiliated)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Omega-3 fatty acid vs. placebo comparator	Dietary supplement: Omega-3 fatty acids; Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day); Other Names: Fish Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Carotid IMT	1 year, 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Pfizer; National Institutes of Health (NIH); Northwest Lipid Research Clinic
• Investigators: Principal Investigator: Pathmaja Paramsothy, MD, University of Washington

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): October 1, 2011
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: July 6, 2006
• First Submitted That Met QC Criteria: July 6, 2006
• First Posted (Estimate): July 10, 2006

Study Record Updates

• Last Update Posted (Estimate): March 2, 2012
• Last Update Submitted That Met QC Criteria: February 29, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Fatty Acids, Omega-3
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 28791-D; 05-8693-D 03