Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diet, Genetics, and CVD Risk Factor Response in Blacks

This study has been completed.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI) Identifier:
First received: March 10, 2004
Last updated: January 24, 2008
Last verified: January 2008

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.

Cardiovascular Diseases
Heart Diseases

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2002
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:


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.


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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its identifier: NCT00079703

Sponsors and Collaborators
Investigator: Michael LeFevre LSU Pennington Biomedical Research Center
  More Information

No publications provided Identifier: NCT00079703     History of Changes
Other Study ID Numbers: 1245
Study First Received: March 10, 2004
Last Updated: January 24, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases processed this record on February 25, 2015