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

NCT02204709 | Terminated

• 1 other identifier: GFHNRC029
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obese; omega-3 fatty acids; fish

Outcome Measures

Primary Outcomes (1)

• Change from baseline in platelet activation at week 6 of each treatment

  Baseline, Week 6

Secondary Outcomes (8)

• 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

Study Arms (3)

Diploid Trout entrees

EXPERIMENTAL

Subjects will consume a 200 gram portion of 2N trout (diploid; two sets of chromosomes) twice weekly in a prepared meal.

Other: 2N Trout

Triploid Trout entrees

EXPERIMENTAL

Subjects will consume a 200 gram portion of 3N trout (triploid; three sets of chromosomes) twice weekly in a prepared meal.

Other: 3N Trout

Tilapia entrees

EXPERIMENTAL

Subjects will consume a 200 gram portion of tilapia twice weekly in a prepared meal.

Other: Tilapia

Interventions

2N Trout OTHER

Diploid/2N trout source

Diploid Trout entrees

3N Trout OTHER

Triploid/3N trout source

Triploid Trout entrees

Tilapia OTHER

Tilapia/control fish source

Tilapia entrees

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI of 30 - 39.9 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Grand Forks Human Nutrition Research Center: lead

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Links

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

MeSH Terms

Conditions

Obesity

Interventions

melanin-concentrating hormone gene-related peptide, tilapia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Picklo, PhD

  USDA Grand Forks Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: June 1, 2015
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)