Effects of Omega-3 Fatty Acids on Markers of Inflammation

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01129050
First received: May 20, 2010
Last updated: May 21, 2010
Last verified: May 2010
  Purpose

The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flax seed oil.


Condition Intervention Phase
Obesity
Hypertriglyceridemia
Insulin Resistance
Hypertension
Behavioral: Fish Oil
Behavioral: Flax Seed Oil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: ALA & EPA/DHA (w-3) Effects on Inflammatory Markers In Insulin Resistant Adults

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Inflammatory Markers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Lipids [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flax seed oil. Each will be given at a lower dose that could realistically be achieved from food sources alone, and at a higher dose that could not realistically be achieved from food alone and would require supplementation. The outcomes being studied are markers of inflammation. The subjects being studied are those with elevated risk factors for diabetes and heart disease that meet the criteria for the "metabolic syndrome". These are the people who are currently not diabetic, and who have not been diagnosed yet with heart disease, who are at risk of developing these diseases and who would likely benefit the most from the omega-3 therapy should it prove to be effective.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Gender:

  • Both women and men
  • Age: > or = 18 years
  • Ethnicity and race: All ethnic and racial backgrounds welcome
  • As defined in ATP III of the National Cholesterol Education program, the metabolic syndrome will be diagnosed as presence of at least three of the following, which will be measured at the screening clinic visit:

Central obesity as measured by waist circumference:

  • Men: Greater than 40 inches
  • Women: Greater than 35 inches

    • Fasting blood triglycerides greater than or equal to 150 mg/dL
    • Blood HDL cholesterol:
  • Men: Less than 40 mg/dL
  • Women: Less than 50 mg/dL

    • Blood pressure greater than or equal to 130/85 mmHg

      • Fasting glucose greater than or equal to 100 mg/dL

Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation

Ability and willingness to give written informed consent

No known active psychiatric illness.

Exclusion Criteria:Daily intake of dietary supplements containing omega-3 FAs within the past month.

  • Fasting blood glucose > 140 mg/dL
  • Significant liver enzyme abnormality
  • AST or ALT more than 2 times the upper limit of normal and/or
  • Bilirubin more than 50% the upper limit of normal
  • Renal disease as measured at baseline:
  • Serum creatinine > 1.30 mg/dL, or
  • Calculated creatinine clearance < 71 mL/min
  • Self reported personal history of:

    • Clotting disorders
    • Clinically significant atherosclerosis (e.g., CAD, PAD)
    • Malignant neoplasm
    • Ongoing infection
    • Inflammatory disease (e.g., rheumatoid arthritis)
  • Subjects currently receiving the following medications (self report):

    • Anti-Inflammatory drugs
    • Lipid lowering drugs including statins
    • Anti-hypertensive drugs
    • Anti-coagulant drugs
  • Body Mass Index (BMI) greater than or equal to 40.
  • Pregnant or Lactating
  • Inability to communicate effectively with study personnel
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129050

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Christopher D Gardner Stanford University
  More Information

Additional Information:
No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher D Gardner, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01129050     History of Changes
Other Study ID Numbers: SU-05042010-5842, 7738
Study First Received: May 20, 2010
Last Updated: May 21, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Hypertriglyceridemia
Insulin Resistance
Obesity
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014