The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

Metabolic Syndrome X Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00350194
• Other study ID #: 28791-D
• Secondary ID: 05-8693-D 03
• Status: Active, not recruiting
• Phase: Phase 0
• First received: July 6, 2006
• Last updated: February 29, 2012
• Start date: October 2006
• Est. completion date: June 2012

Study information

• Verified date: February 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Omega-3 fatty acids
Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)

Locations

Country	Name	City	State
United States	Northwest Lipid Research Clinic (University of Washington Affiliated)	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institutes of Health (NIH), Northwest Lipid Research Clinic, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Carotid IMT		1 year, 2 years	No
Secondary	Lipid (apolipoproteins and lipid parameters)		1 year, 2 years	No
Secondary	hs-CRP & SAA		1 year, 2 years	No
Secondary	Glucose		1 year, 2 years	No
Secondary	Insulin		1 year, 2 years	No
Secondary	adiponectin		1 year, 2 years	No
Secondary	urine microalbumin/creatinine		1 year, 2 years	No
Secondary	Serum Fatty Acids		1 year, 2 years	No