Status:
COMPLETED
Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENE-FORECAST): Sodium Intervention Trial (SIT)
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsors:
National Human Genome Research Institute (NHGRI)
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
Background: Hypertension is a risk factor for heart disease. Low-sodium diets rich in fruits, vegetables, and other healthy foods are a good way to reduce blood pressure in people with hypertension. ...
Detailed 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, who...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- African American men and women who are former GENE-FORECAST participants between 21 and 65 years of age. This criterion is inclusive of self-identified AA of both Hispanic, Latino and non-Hispanic, Latino ethnicities. Normotensive participants with systolic blood pressure (SBP) \<140 mm Hg and diastolic blood pressure (DBP) \<90 mm Hg and the absence of a history of prior diagnosis of hypertension.
- Willingness and ability to participate in study procedures.
- EXCLUSION CRITERIA:
- Individuals who are pregnant or breast-feeding.
- Individuals with high blood pressure or a history of hypertension.
- Individuals with a history of myocardial infarction, stroke, heart failure, diabetes, chronic liver or kidney diseases.
- Individuals who are taking antihypertensive, antidepressants, antidiabetic and antibiotic medications.
- Individuals currently participating in another NIH protocol.
- Individuals unable to provide informed consent.
Exclusion
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04717336
Start Date
January 22 2021
End Date
July 8 2022
Last Update
April 27 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892