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

NCT ID: NCT02204709

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-03-25

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Diploid Trout entrees

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

Group Type EXPERIMENTAL

2N Trout

Intervention Type OTHER

Diploid/2N trout source

Triploid Trout entrees

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

Group Type EXPERIMENTAL

3N Trout

Intervention Type OTHER

Triploid/3N trout source

Tilapia entrees

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

Group Type EXPERIMENTAL

Tilapia

Intervention Type OTHER

Tilapia/control fish source

Interventions

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2N Trout

Diploid/2N trout source

Intervention Type OTHER

3N Trout

Triploid/3N trout source

Intervention Type OTHER

Tilapia

Tilapia/control fish source

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Picklo, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

Locations

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USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/

Grand Forks Human Nutrition Research Center Current Nutrition Studies

Other Identifiers

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GFHNRC029

Identifier Type: -

Identifier Source: org_study_id

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