Diet, Genetics, and CVD Risk Factor Response in Blacks

To test the hypothesis that the responsiveness of major and emerging cardiovascular disease risk factors to changes in diet composition clusters within families depending on genetic susceptibility factors.

Study Overview

Status

Completed

Detailed Description

BACKGROUND:

Reduction in risk of cardiovascular disease (CVD) through dietary change has considerable potential for a beneficial impact on public health. On a population basis, moderation of both lipid profiles and blood pressure can be accomplished readily with a prudent diet. Nevertheless, individual response to dietary impact on CVD risk factors varies widely, presumably as a result of genetic differences. In particular, Blacks who constitute a subpopulation with documented increased risk of morbidity and mortality from CVD would disproportionately benefit from interventions designed to maximize the impact of dietary change tailored to individual genetic makeup. Therefore, study of the influence of diet on CVD risk factors, along with enhanced understanding of the genetic components involved, would greatly potentiate chronic disease interventions.

The study is conducted in response to a Request for Applications issued in October, 2001 on the Interaction of Genes and the Environment in Shaping Risk Factors for Heart, Lung, Blood, and Sleep Disorders.

DESIGN NARRATIVE:

Two-generational family lines will be identified in Blacks with elevated low density lipoprotein-C (LDLC) in probands. The population will be fed a controlled diet contrasting an established heart healthy regimen with a typical American one. Concomitant rigorous genetic, anthropometric, and behavioral evaluation will provide data with which to analyze individual differences in response to consistent dietary intake. In Specific Aim 1, Black, two-generational, families will be recruited and provided interventional diets designed to reduce (or not) LDL-C and blood pressure. In Specific Aim 2, non-genetic predictors of CVD risk factor response will be identified through extensive assessments of baseline behavioral characteristics, anthropometric features, and metabolic factors. In Specific Aim 3, the underlying genetic factors that predispose to response (or the lack of) to dietary interventions will be identified through the examination of polymorphisms in candidate genes and the identification of susceptibility loci by linkage analyses. In Specific Aim 4, interactions between diet, CVD risk factor response and genetic factors will be dissected through measures of potential mediating metabolic pathways.

Study Type

Observational

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

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

No eligibility criteria

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?

Collaborators and Investigators

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

Investigators

  • Michael LeFevre, LSU Pennington Biomedical Research Center

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, 2002

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

March 10, 2004

First Submitted That Met QC Criteria

March 12, 2004

First Posted (Estimate)

March 15, 2004

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1245
  • U01HL072510 (U.S. NIH Grant/Contract)

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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