Effect of High Omega-3 Fish Intake on Lipid Peroxidation

January 18, 2022 updated by: USDA Grand Forks Human Nutrition Research Center
The overall goal of this project is to identify an appropriate level of high omega-3 fish (salmon) consumption that will promote optimal omega 3 nutritional status without increasing the level of lipid oxidation in the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studies have demonstrated that the intakes of fatty fish and fish oils are associated with decreases in cardiovascular disease and other chronic disease states. This is related to the long chain omega-3 fatty acid (n-3) content of fish and fish oil, specifically eicosapentaenoic acid and docosahexaenoic acid. Although the consumption of high n-3 fish is recommended in the 2005 US Dietary Guidelines for Americans, no specific consumption levels are made for the fatty acid eicosapentaenoic acid (EPA) and/or the fatty acid docosahexaenoic acid (DHA) or total fish intake.

Consumption of high n-3 fish or dietary supplementation of fish oil will lead to increased levels of these fatty acids in plasma lipoproteins, cell and tissue lipid. This change in membrane lipid is thought to be responsible for the anti-inflammatory effects of n-3. Because highly unsaturated fatty acid are subject to peroxidation, the level of fish intake that is sufficient to modify membrane n-3 content and the exact level that enhances peroxidation is unknown.

We will perform a dose-response feeling study in which varied levels of fish (salmon) will be provided in random order separated by 4 or more week washout periods. We will assess the level of cell membrane enrichment with n-3 and the effect on lipid peroxidation outcomes.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Grand Forks, North Dakota, United States, 58202
        • USDA ARS Grand Forks Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 25-34.9
  • Non-smoker
  • Free of major medical conditions
  • Willing to comply with protocol requirements

Exclusion Criteria:

  • Use of lipid modifying drugs or supplements
  • Taking fish oil or flax supplements
  • Regular fish consumer
  • Planning to gain to lose weight
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 90 grams of Salmon
Subjects will consume 90 grams of salmon twice a week for 4 weeks
Dietary supplement: Omega-3 fish oil provided by salmon
Eating 3 different amounts of provided salmon twice a week for four weeks
Active Comparator: 180 grams of salmon
Subjects will consume 180 grams of salmon twice a week for 4 weeks
Dietary supplement: Omega-3 fish oil provided by salmon
Eating 3 different amounts of provided salmon twice a week for four weeks
Active Comparator: 270 Grams of Salmon
Subjects will consume 270 grams of salmon twice a week for 4 weeks
Dietary supplement: Omega-3 fish oil provided by salmon
Eating 3 different amounts of provided salmon twice a week for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long chain omega-3 fatty acid (n-3)
Time Frame: 6 months
Effect of different levels of n-3 intake on n-3 fatty acids in plasma lipoproteins, cell and tissue lipids (cell enrichment)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lipid peroxidation
Time Frame: 6 months
Effect of different levels of n-3 intake on lipid peroxidation
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Grand Forks Human Nutrition Research Center

Collaborators

United States Department of Agriculture (USDA)
University of North Dakota

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 16, 2010

First Posted (Estimate)

August 17, 2010

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • GFHNRC017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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