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

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Other: 2N Trout; Other: 3N Trout; Other: Tilapia

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Grand Forks, North Dakota, United States, 58203
      • USDA Grand Forks Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: USDA Grand Forks Human Nutrition Research Center
• Investigators: Principal Investigator: Matthew Picklo, PhD, USDA Grand Forks Human Nutrition Research Center

Publications and helpful links

Helpful Links

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): March 25, 2020
• Study Completion (Actual): March 25, 2020

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: obese; omega-3 fatty acids; fish
• Other Study ID Numbers: GFHNRC029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No