NCT01183520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

2.3 years

First QC Date

August 16, 2010

Last Update Submit

January 18, 2022

Conditions

Omega-3 Fatty AcidsLipid Peroxidation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • lipid peroxidation

    6 months

Study Arms (3)

90 grams of Salmon

ACTIVE COMPARATOR

Subjects will consume 90 grams of salmon twice a week for 4 weeks

Dietary Supplement: Omega-3 fish oil provided by salmon

180 grams of salmon

ACTIVE COMPARATOR

Subjects will consume 180 grams of salmon twice a week for 4 weeks

Dietary Supplement: Omega-3 fish oil provided by salmon

270 Grams of Salmon

ACTIVE COMPARATOR

Subjects will consume 270 grams of salmon twice a week for 4 weeks

Dietary Supplement: Omega-3 fish oil provided by salmon

Interventions

Omega-3 fish oil provided by salmonDIETARY_SUPPLEMENT

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

180 grams of salmon270 Grams of Salmon90 grams of Salmon

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA ARS Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58202, United States

Location

Related Publications (6)

  • Holman RT. Control of polyunsaturated acids in tissue lipids. J Am Coll Nutr. 1986;5(2):183-211. doi: 10.1080/07315724.1986.10720125.

    PMID: 2873160BACKGROUND

  • 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. doi: 10.1093/jn/131.2.231.

    PMID: 11160538BACKGROUND

  • 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. doi: 10.1074/jbc.273.22.13605.

    PMID: 9593698BACKGROUND

  • 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.

    PMID: 19520854BACKGROUND

  • 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. doi: 10.1016/j.chemphyslip.2003.09.016.

    PMID: 15037162BACKGROUND

  • Raatz SK, Scheett AJ, Johnson LK, Jahns L. Validity of electronic diet recording nutrient estimates compared to dietitian analysis of diet records: randomized controlled trial. J Med Internet Res. 2015 Jan 20;17(1):e21. doi: 10.2196/jmir.3744.

    PMID: 25604640DERIVED

Related Links

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
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 17, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 2, 2022

Record last verified: 2022-01

Locations

US(1)