Dietary Fatty Acids, PPAR Activated Genes, and CHD

April 18, 2017 updated by: Hannia Campos, Harvard School of Public Health (HSPH)
To examine the relationship between genetic and dietary factors that modify the risk of coronary heart disease (CHD).

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

Coronary heart disease (CHD) is the major cause of death in most industrialized and developing countries. Links between genetic and dietary factors that modify the risk of CHD should give fundamental insight into its causes and improve population-based CHD prevention strategies.

DESIGN NARRATIVE:

The study will identify genes that modulate the association between dietary fatty acids (FAs) and myocardial infarction (MI). The study uses DNA samples obtained during a population-based, case-control study in Costa Rica of 2,150 subjects who experienced myocardial infarctions and 2,150 matched controls. Biochemical measurements, dietary data, and general information are available for this population. One unique aspect of the study is that adipose tissue biomarkers of polyunsaturated FAs will be used to evaluate dietary exposure variables. Adipose tissue biomarkers (i.e., alpha-linolenic and linoleic acid) are very good indicators of intake in this population. Furthermore, this study showed that increased levels of these biomarkers in adipose tissue are strongly associated with decreased risk of MI, whereas an increase in 18:2 trans FAs increase the risk of MI. Gene-diet association studies and a "candidate pathway" approach will be used to elucidate genetic mechanisms that link risk of MI with exposure to polyunsaturated FAs [including cis and trans isomers of linoleic acid (n-6), and alpha-linolenic acid (n-3)]. The focus will be on peroxisome proliferator-activated receptor (PPAR) genes, and PPAR-regulated genes, that are involved in vascular inflammation. Among controls, the investigators will examine whether genetic and dietary factors independently affect biochemical markers (phenotypes) of the proposed genes. They will also test whether these phenotypes are more clearly identified when genetic and dietary factors are examined together. Because polyunsaturated FAs are important as activators of PPARs and their capacity to regulate gene expression at the level of transcription, this metabolic system is a suitable candidate for the study.

Study Type

Observational

Enrollment (Actual)

4547

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hispanic American of mestizo background living in Costa Rica

Description

First acute MI Living in catchment area Randomly selected controls Matched for age sex and area of residence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Hannia Campos, Harvard School of Public Health (HSPH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

October 9, 2003

First Submitted That Met QC Criteria

October 10, 2003

First Posted (Estimate)

October 13, 2003

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1235
  • R01HL071888 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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