Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENE-FORECAST): Sodium Intervention Trial (SIT)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiovascular Disease
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 21 years and 65 years
- Gender
- Both males and females
Description
The objective of this study is to implement a sodium intervention investigation to assess the effect of increased dietary sodium intake on changes in blood pressure, vascular function, microbiome, whole blood epigenome, whole blood and urine transcriptome as outcome measures. The study design will i...
The objective of this study is to implement a sodium intervention investigation to assess the effect of increased dietary sodium intake on changes in blood pressure, vascular function, microbiome, whole blood epigenome, whole blood and urine transcriptome as outcome measures. The study design will include a double-blind, cross-over treatment/placebo trial among 40 former African Americans GENE-FORECAST participants with normal blood pressure and will last 7weeks. It is hypothesized that exposure to increased dietary sodium will affect blood pressure, whole blood epigenome, whole blood and urine transcriptome, vascular function, microbiome and blood pressure.
Tracking Information
- NCT #
- NCT04717336
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Gary H Gibbons, M.D. National Heart, Lung, and Blood Institute (NHLBI)
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