NCT00536185

Brief Summary

We hope to learn more about why certain people have higher levels of the 5-LO protein and whether taking fish oil supplements gives such individuals greater protection than others against cardiovascular disease. The 5-LO protein is important in the development of heart disease because it converts a type of oil from meat into a compound that can cause inflammation in blood vessels. This inflammation is a major cause of heart disease. Researchers think that people with higher levels of a protein called 5-LO in their white blood cells may have a healthier response to using fish oil supplements than do people with lower levels of this protein.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

December 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

September 5, 2007

Last Update Submit

March 20, 2026

Conditions

Heart Disease

Keywords

ALOX55-lipoxygenaseHeart DiseaseBlacks

Outcome Measures

Primary Outcomes (1)

  • (a) ALOX5 mRNA and protein in resting and stimulated cultures of purified monocytes and purified granulocytes (b) Arachidonic acid-derived leukotrienes in resting and stimulated cultures of whole blood, purified monocytes and purified granulocytes

    6 weeks

Secondary Outcomes (1)

  • Proinflammatory cytokines, C-reactive protein, triglycerides, glucose and insulin in plasma, and resting heart rate and blood pressure

    6 weeks

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: Fish Oil

2

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Fish OilDIETARY_SUPPLEMENT

capsules, 5.0 g/d fish oil concentrate (3.0 g/d EPA + DHA), 6 weeks

1
PlaceboDIETARY_SUPPLEMENT

capsule, 5.0 g/d corn/soybean oil (50/50 mixture), 6 weeks

2

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • African-American, Black, or persons of African Descent
  • Generally Healthy
  • years of age

You may not qualify if:

  • Chronic Diseases (Heart disease, cancer, diabetes, etc.)
  • Smoke \> 14 cigarettes per week
  • Consume \> 14 alcoholic drinks per week
  • Pregnant Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UC Davis, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Ethnich Health Institute

Oakland, California, 94609, United States

Location

UC Davis (TICON-1)

Sacramento, California, 95820, United States

Location

Related Publications (5)

  • Vikman S, Brena RM, Armstrong P, Hartiala J, Stephensen CB, Allayee H. Functional analysis of 5-lipoxygenase promoter repeat variants. Hum Mol Genet. 2009 Dec 1;18(23):4521-9. doi: 10.1093/hmg/ddp414. Epub 2009 Aug 28.

    PMID: 19717473RESULT

  • O'Sullivan A, Armstrong P, Schuster GU, Pedersen TL, Allayee H, Stephensen CB, Newman JW. Habitual diets rich in dark-green vegetables are associated with an increased response to omega-3 fatty acid supplementation in Americans of African ancestry. J Nutr. 2014 Feb;144(2):123-31. doi: 10.3945/jn.113.181875. Epub 2013 Nov 20.

    PMID: 24259553RESULT

  • Armstrong P, Kelley DS, Newman JW, Staggers FE Sr, Hartiala J, Allayee H, Stephensen CB. Arachidonate 5-lipoxygenase gene variants affect response to fish oil supplementation by healthy African Americans. J Nutr. 2012 Aug;142(8):1417-28. doi: 10.3945/jn.112.159814. Epub 2012 Jun 27.

    PMID: 22739369RESULT

  • Stephensen CB, Armstrong P, Newman JW, Pedersen TL, Legault J, Schuster GU, Kelley D, Vikman S, Hartiala J, Nassir R, Seldin MF, Allayee H. ALOX5 gene variants affect eicosanoid production and response to fish oil supplementation. J Lipid Res. 2011 May;52(5):991-1003. doi: 10.1194/jlr.P012864. Epub 2011 Feb 4.

    PMID: 21296957RESULT

  • Hartiala J, Li D, Conti DV, Vikman S, Patel Y, Tang WH, Brennan ML, Newman JW, Stephensen CB, Armstrong P, Hazen SL, Allayee H. Genetic contribution of the leukotriene pathway to coronary artery disease. Hum Genet. 2011 Jun;129(6):617-27. doi: 10.1007/s00439-011-0963-3. Epub 2011 Feb 4.

    PMID: 21293878RESULT

Related Links

MeSH Terms

Conditions

Heart Diseases

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Charles B Stephensen, PhD

    UC Davis & U.S. Department of Agriculture

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 27, 2007

Study Start

December 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

US(3)