Cardiovascular DiseasesNCT00079703
Diet, Genetics, and CVD Risk Factor Response in Blacks
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2002to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2004 (estimated)
- Study startSep 2002
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael LeFevre, LSU Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079703
- Sponsor's protocol ID
- 1245
- Other IDs
- U01HL072510
- Status last verified
- Jan 2008
- First submitted
- 10 Mar 2004
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Law HG, Khan MA, Zhang W, Bang H, Rood J, Most M, Lefevre M, Berglund L, Enkhmaa B. Reducing saturated fat intake lowers LDL-C but increases Lp(a) levels in African Americans: the GET-READI feeding trial. J Lipid Res. 2023 Sep;64(9):100420. doi: 10.1016/j.jlr.2023.100420. Epub 2023 Jul 22.
PubMed 37482217
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Genetics, and CVD Risk Factor Response in Blacks
- ClinicalTrials.gov ID
- NCT00079703
- Acronym / sponsor ID
- 1245
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2002
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 37482217Law HG, Khan MA, Zhang W, Bang H, Rood J, Most M, Lefevre M, Berglund L, Enkhmaa B. Reducing saturated fat intake lowers LDL-C but increases Lp(a) levels in African Americans: the GET-READI feeding trial. J Lipid Res. 2023 Sep;64(9):100420. doi: 10.1016/j.jlr.2023.100420. Epub 2023 Jul 22.
Related trials for Cardiovascular Diseases
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael LeFevre
LSU Pennington Biomedical Research Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00079703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.