Effect of High Omega-3 Fish Intake on Lipid Peroxidation

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

USDA Beltsville Human Nutrition Research Center

University of North Dakota

Information provided by (Responsible Party):

Susan Raatz, USDA Grand Forks Human Nutrition Research Center

ClinicalTrials.gov Identifier:

NCT01183520

First received: August 16, 2010

Last updated: September 20, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 16, 2010

Last Updated Date

September 20, 2012

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Long chain omega-3 fatty acid (n-3) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Effect of different levels of n-3 intake on n-3 fatty acids in plasma lipoproteins, cell and tissue lipids (cell enrichment)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01183520 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

lipid peroxidation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Effect of different levels of n-3 intake on lipid peroxidation

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of High Omega-3 Fish Intake on Lipid Peroxidation

Official Title ^ICMJE

Effect of High Omega-3 Fish Intake on Lipid Peroxidation

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Omega-3 Fatty Acids
Lipid Peroxidation

Intervention ^ICMJE

Dietary Supplement: Omega-3 fish oil provided by salmon

Eating 3 different amounts of provided salmon twice a week for four weeks

Study Arm (s)

Active Comparator: 90 grams of Salmon
Subjects will consume 90 grams of salmon twice a week for 4 weeks

Intervention: Dietary Supplement: Omega-3 fish oil provided by salmon
Active Comparator: 180 grams of salmon
Subjects will consume 180 grams of salmon twice a week for 4 weeks

Intervention: Dietary Supplement: Omega-3 fish oil provided by salmon
Active Comparator: 270 Grams of Salmon
Subjects will consume 270 grams of salmon twice a week for 4 weeks

Intervention: Dietary Supplement: Omega-3 fish oil provided by salmon

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01183520

Other Study ID Numbers ^ICMJE

GFHNRC017

Has Data Monitoring Committee

Responsible Party

Susan Raatz, USDA Grand Forks Human Nutrition Research Center

Study Sponsor ^ICMJE

USDA Grand Forks Human Nutrition Research Center

Collaborators ^ICMJE

USDA Beltsville Human Nutrition Research Center
University of North Dakota

Investigators ^ICMJE

Principal Investigator:

Susan K Raatz, PhD, RD

USDA Grand Forks Human Nutrition Research Center

Information Provided By

USDA Grand Forks Human Nutrition Research Center

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top