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The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pfizer
National Institutes of Health (NIH)
Northwest Lipid Research Clinic
Information provided by (Responsible Party):
Pathmaja Paramsothy, University of Washington
ClinicalTrials.gov Identifier:
NCT00350194
First received: July 6, 2006
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome X
 Dietary Supplement: Omega-3 fatty acids
 Phase 0

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in Carotid IMT [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid (apolipoproteins and lipid parameters) [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • hs-CRP & SAA [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • adiponectin [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • urine microalbumin/creatinine [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • Serum Fatty Acids [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Study Completion Date: June 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Fish Oil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350194

Locations
United States, Washington
Northwest Lipid Research Clinic (University of Washington Affiliated)
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Pfizer
National Institutes of Health (NIH)
Northwest Lipid Research Clinic
Investigators
Principal Investigator: Pathmaja Paramsothy, MD University of Washington
  More Information

No publications provided

Responsible Party: Pathmaja Paramsothy, Assistant Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT00350194     History of Changes
Other Study ID Numbers: 28791-D, 05-8693-D 03
Study First Received: July 6, 2006
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Fatty Acids, Omega-3

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013