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

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Other: Tilapia; Other: 2N Trout; Other: 3N Trout

• Registration Number: NCT02204709
• Lead Sponsor: USDA Grand Forks Human Nutrition Research Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Study Start: 2015-06
• Primary Completion: 2020-03-25
• Study Completion: 2020-03-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tilapia entrees	Tilapia	Subjects will consume a 200 gram portion of tilapia twice weekly in a prepared meal.
Diploid Trout entrees	2N Trout	Subjects will consume a 200 gram portion of 2N trout (diploid; two sets of chromosomes) twice weekly in a prepared meal.
Triploid Trout entrees	3N Trout	Subjects will consume a 200 gram portion of 3N trout (triploid; three sets of chromosomes) twice weekly in a prepared meal.

Primary Outcome Measures

Name	Time	Method
Change from baseline in platelet activation at week 6 of each treatment	Baseline, Week 6

Secondary Outcome Measures

Name	Time	Method
Change from baseline in plasma tumor necrosis factor alpha (TNFa) 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 platelet fatty acids 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 plasma interleukin-6 (IL-6) 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 prostaglandin I2 (PGI2-M) at week 6 of each treatment	Baseline, Week 6

Trial Locations

Locations (1)

USDA Grand Forks Human Nutrition Research Center; 🇺🇸 Grand Forks, North Dakota, United States