Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079703
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2004-03-10
Brief Title:
Diet Genetics and CVD Risk Factor Response in Blacks
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL072510 | NIH | None | httpsreporternihgovquickSearchU01HL072510 |