Disease Risk Reduction and Omega-3 Rich Rainbow Trout (Fish for Health)

Study Overview
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Brief Summary
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The purpose of this study is to determine how eating fish raised to have different levels of omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated cardiovascular risk.

Detailed Description
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Consumption of fish high in long chain omega-3 fatty acids (LCn3) is associated with reduction of cardiovascular disease (CVD) risk. CVD is a major cause of death in the United States. The current obesity epidemic contributes significantly to elevated CVD risk by increasing inflammation and platelet dysfunction. Prevention of CVD is a public health goal and comprises several avenues of action, of which inclusion of LCn3-rich fish in the diet may be one of the most effective. Obese participants will participate in a double blind, randomized, cross-over designed trial in which they will consume twice-weekly a prepared meal containing diploid (2N) farmed rainbow trout, triploid (3N) farmed rainbow trout containing higher levels of LCn3, or tilapia, a low LCn3 fish.

Official Title
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Disease Risk Reduction and n-3 Rich Rainbow Trout (Fish for Health)

Conditions
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Obesity

Intervention / Treatment
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* Other: 2N Trout
* Other: 3N Trout
* Other: Tilapia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI of 30 - 39.9 kg/m2 Exclusion Criteria: Are allergic to fish Use tobacco products or nicotine in any form including snuff, pills, and patches, or e-cigarettes in the past 6 months Have established cardiovascular, pulmonary, and/or a metabolic disease such as diabetes Have uncontrolled high blood pressure Have alcohol, anabolic steroids, or other substance abuse issues Consume more than 3 alcoholic drinks/week Have cancer Are pregnant or nursing Take non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen or Aleve, lipid modifying drugs such as statins, take medications for blood glucose such as insulin or metformin

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diploid Trout entrees<br>Subjects will consume a 200 gram portion of 2N trout (diploid; two sets of chromosomes) twice weekly in a prepared meal. | Other: 2N Trout<br>* Diploid/2N trout source<br>|
| Experimental: Triploid Trout entrees<br>Subjects will consume a 200 gram portion of 3N trout (triploid; three sets of chromosomes) twice weekly in a prepared meal. | Other: 3N Trout<br>* Triploid/3N trout source<br>|
| Experimental: Tilapia entrees<br>Subjects will consume a 200 gram portion of tilapia twice weekly in a prepared meal. | Other: Tilapia<br>* Tilapia/control fish source<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in platelet activation at week 6 of each treatment |  | Baseline, Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in plasma interleukin-6 (IL-6) at week 6 of each treatment |  | Baseline, Week 6 | 
| Change from baseline in plasma tumor necrosis factor alpha (TNFa) at week 6 of each treatment |  | Baseline, Week 6 | 
| Change from baseline in urinary prostaglandin E2 (PGE2) at week 6 of each treatment |  | Baseline, Week 6 | 
| Change from baseline in urinary thromboxane B2 (TxB2-M) at week 6 of each treatment |  | Baseline, Week 6 | 
| Change from baseline in urinary prostaglandin I2 (PGI2-M) at week 6 of each treatment |  | Baseline, Week 6 | 
| Change from baseline in serum thromboxane B2 (TxB2) at week 6 of each treatment |  | Baseline, Week 6 | 
| Change from baseline in plasma phospholipid fatty acids at week 6 of each treatment |  | Baseline, Week 6 | 
| Change from baseline in platelet fatty acids at week 6 of each treatment |  | Baseline, Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obese, omega-3 fatty acids, fish