Dietary Fatty Acids, PPAR Activated Genes, and CHD

Sponsor
Harvard School of Public Health (HSPH) (Other)
Overall Status
Completed
CT.gov ID
NCT00071019
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
4,547
35

Study Details

Study Description

Brief Summary

To examine the relationship between genetic and dietary factors that modify the risk of coronary heart disease (CHD).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    4547 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Dietary Fatty Acids, PPAR Activated Genes, and CHD
    Study Start Date :
    Sep 1, 2003
    Actual Primary Completion Date :
    Aug 1, 2006
    Actual Study Completion Date :
    Aug 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 85 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

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

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Harvard School of Public Health (HSPH)
      • National Heart, Lung, and Blood Institute (NHLBI)

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Hannia Campos, Senior Lecturer, Harvard School of Public Health (HSPH)
      ClinicalTrials.gov Identifier:
      NCT00071019
      Other Study ID Numbers:
      • 1235
      • R01HL071888
      First Posted:
      Oct 13, 2003
      Last Update Posted:
      Apr 20, 2017
      Last Verified:
      Apr 1, 2017
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Studies a U.S. FDA-regulated Drug Product:
      No
      Studies a U.S. FDA-regulated Device Product:
      No
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Apr 20, 2017