Effects of Omega-3 Fatty Acids on Markers of Inflammation
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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 |
- Inflammatory Markers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- 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) |
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 |
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| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| 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 May 16, 2013