Heart & Health Study

NCT00536185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Fish Oil

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH
  • Office of Dietary Supplements (ODS)

    collaborator NIH
  • University of California, Davis

    collaborator OTHER
  • USDA Beltsville Human Nutrition Research Center

    collaborator FED
  • Alta Bates Summit Medical Center

    collaborator OTHER
  • University of Southern California

    collaborator OTHER
  • USDA, Western Human Nutrition Research Center

    lead FED

Principal Investigators

  • Charles B Stephensen, PhD · UC Davis & U.S. Department of Agriculture

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536185 on ClinicalTrials.gov