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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01183520
Other study ID # GFHNRC017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2010
Est. completion date December 2012

Study information

Verified date January 2022
Source USDA Grand Forks Human Nutrition Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Omega-3 fish oil provided by salmon
Eating 3 different amounts of provided salmon twice a week for four weeks

Locations

Country Name City State
United States USDA ARS Grand Forks Human Nutrition Research Center Grand Forks North Dakota

Sponsors (3)

Lead Sponsor Collaborator
USDA Grand Forks Human Nutrition Research Center United States Department of Agriculture (USDA), University of North Dakota

Country where clinical trial is conducted

United States, 

References & Publications (5)

Holman RT. Control of polyunsaturated acids in tissue lipids. J Am Coll Nutr. 1986;5(2):183-211. Review. — View Citation

Raatz SK, Bibus D, Thomas W, Kris-Etherton P. Total fat intake modifies plasma fatty acid composition in humans. J Nutr. 2001 Feb;131(2):231-4. — View Citation

Roberts LJ 2nd, Fessel JP. The biochemistry of the isoprostane, neuroprostane, and isofuran pathways of lipid peroxidation. Chem Phys Lipids. 2004 Mar;128(1-2):173-86. Review. — View Citation

Roberts LJ 2nd, Montine TJ, Markesbery WR, Tapper AR, Hardy P, Chemtob S, Dettbarn WD, Morrow JD. Formation of isoprostane-like compounds (neuroprostanes) in vivo from docosahexaenoic acid. J Biol Chem. 1998 May 29;273(22):13605-12. — View Citation

Song WL, Paschos G, Fries S, Reilly MP, Yu Y, Rokach J, Chang CT, Patel P, Lawson JA, Fitzgerald GA. Novel eicosapentaenoic acid-derived F3-isoprostanes as biomarkers of lipid peroxidation. J Biol Chem. 2009 Aug 28;284(35):23636-43. doi: 10.1074/jbc.M109.024075. Epub 2009 Jun 11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Long chain omega-3 fatty acid (n-3) 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 lipid peroxidation Effect of different levels of n-3 intake on lipid peroxidation 6 months
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