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Effects of Omega-3 Fatty Acids on Markers of Inflammation

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Christopher Gardner, Stanford University
ClinicalTrials.gov Identifier:
NCT01129050
First received: May 20, 2010
Last updated: May 31, 2017
Last verified: May 2017
  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 flaxseed oil.

Condition Intervention
Obesity Hypertriglyceridemia Insulin Resistance Hypertension Dietary Supplement: Fish Oil Dietary Supplement: Flaxseed Oil Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Effects of Plant and Marine Omega-3 (w-3) Fatty Acids on Inflammatory Markers In Insulin Resistant Adults

Resource links provided by NLM:


Further study details as provided by Christopher Gardner, Stanford University:

Primary Outcome Measures:
  • Change from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks. [ Time Frame: Baseline and 8 weeks ]
    Change was calculated as the value at 8 weeks minus the value at baseline


Secondary Outcome Measures:
  • Change from baseline in red blood cells (RBC) Fatty Acids at 8 weeks. [ Time Frame: Baseline and 8 weeks ]
    Change was calculated as the value at 8 weeks minus the value at baseline

  • Change from baseline in low-density lipoprotein (LDL) cholesterol at 8 weeks. [ Time Frame: Baseline and 8 weeks ]
    Change was calculated as the value at 8 weeks minus the value at baseline

  • Change from baseline in high-density lipoprotein (HDL) cholesterol at 8 weeks. [ Time Frame: Baseline and 8 weeks ]
    Change was calculated as the value at 8 weeks minus the value at baseline

  • Change from baseline in triglycerides at 8 weeks. [ Time Frame: Baseline and 8 weeks ]
    Change was calculated as the value at 8 weeks minus the value at baseline


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)
Arms Assigned Interventions
Experimental: Low-dose Flaxseed Oil
2.2 g ALA (alpha-linolenic acid) per day
Dietary Supplement: Flaxseed Oil
Flaxseed oil capsule
Experimental: High-dose Flaxseed Oil
6.6 g ALA (alpha-linolenic acid) per day
Dietary Supplement: Flaxseed Oil
Flaxseed oil capsule
Experimental: Low-dose Fish Oil
1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day
Dietary Supplement: Fish Oil
Fish oil capsule
Experimental: High-dose Fish Oil
3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day
Dietary Supplement: Fish Oil
Fish oil capsule
Placebo Comparator: Placebo
4 g or 6 g soybean oil per day
Dietary Supplement: Placebo
Soybean oil capsule

Detailed Description:
The primary aim 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 flaxseed 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Christopher D Gardner Stanford University
  More Information

Additional Information:
Publications:
Responsible Party: Christopher Gardner, Professor of Medicine (Research), Stanford University
ClinicalTrials.gov Identifier: NCT01129050     History of Changes
Other Study ID Numbers: SU-05042010-5842
R21AT003465-01 ( U.S. NIH Grant/Contract )
Study First Received: May 20, 2010
Last Updated: May 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christopher Gardner, Stanford University:
Fish oil
Omega-3 fatty acids
Metabolic syndrome
Adults

Additional relevant MeSH terms:
Insulin Resistance
Hypertriglyceridemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on July 27, 2017