Effects of Omega-3 Fatty Acids on Markers of Inflammation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Plant and Marine Omega-3 (w-3) Fatty Acids on Inflammatory Markers In Insulin Resistant Adults

Conditions
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Obesity, Hypertriglyceridemia, Insulin Resistance, Hypertension

Intervention / Treatment
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* Dietary Supplement: Fish Oil
* Dietary Supplement: Flaxseed Oil
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose Flaxseed Oil<br>2.2 g ALA (alpha-linolenic acid) per day | Dietary Supplement: Flaxseed Oil<br>* Flaxseed oil capsule<br>|
| Experimental: High-dose Flaxseed Oil<br>6.6 g ALA (alpha-linolenic acid) per day | Dietary Supplement: Flaxseed Oil<br>* Flaxseed oil capsule<br>|
| Experimental: Low-dose Fish Oil<br>1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day | Dietary Supplement: Fish Oil<br>* Fish oil capsule<br>|
| Experimental: High-dose Fish Oil<br>3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day | Dietary Supplement: Fish Oil<br>* Fish oil capsule<br>|
| Placebo Comparator: Placebo<br>4 g or 6 g soybean oil per day | Dietary Supplement: Placebo<br>* Soybean oil capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks. | Change was calculated as the value at 8 weeks minus the value at baseline | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in red blood cells (RBC) Fatty Acids at 8 weeks. | Change was calculated as the value at 8 weeks minus the value at baseline | Baseline and 8 weeks | 
| Change from baseline in low-density lipoprotein (LDL) cholesterol at 8 weeks. | Change was calculated as the value at 8 weeks minus the value at baseline | Baseline and 8 weeks | 
| Change from baseline in high-density lipoprotein (HDL) cholesterol at 8 weeks. | Change was calculated as the value at 8 weeks minus the value at baseline | Baseline and 8 weeks | 
| Change from baseline in triglycerides at 8 weeks. | Change was calculated as the value at 8 weeks minus the value at baseline | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish oil, Omega-3 fatty acids, Metabolic syndrome, Adults