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The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00350194
Recruitment Status : Unknown
Verified February 2012 by Pathmaja Paramsothy, University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : July 10, 2006
Last Update Posted : March 2, 2012
National Institutes of Health (NIH)
Northwest Lipid Research Clinic
Information provided by (Responsible Party):
Pathmaja Paramsothy, University of Washington

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Dietary Supplement: Omega-3 fatty acids Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2006
Primary Completion Date : October 2011
Estimated Study Completion Date : June 2012

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 Name: Fish Oil

Primary Outcome Measures :
  1. Change in Carotid IMT [ Time Frame: 1 year, 2 years ]

Secondary Outcome Measures :
  1. Lipid (apolipoproteins and lipid parameters) [ Time Frame: 1 year, 2 years ]
  2. hs-CRP & SAA [ Time Frame: 1 year, 2 years ]
  3. Glucose [ Time Frame: 1 year, 2 years ]
  4. Insulin [ Time Frame: 1 year, 2 years ]
  5. adiponectin [ Time Frame: 1 year, 2 years ]
  6. urine microalbumin/creatinine [ Time Frame: 1 year, 2 years ]
  7. Serum Fatty Acids [ Time Frame: 1 year, 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350194

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

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
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: February 2012

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

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