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NCT04717336 · ClinicalTrials.gov registry record · NA
Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENE-FORECAST): Sodium Intervention Trial (SIT)
A NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT04717336: Completed NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT04717336 is a NA study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04717336, a NA study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study 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. Researchers want to learn more about why African Americans seem to have the greatest benefit from certain dietary interventions. Objective: To better understand the body's response to adding more salt to the diet. Eligibility: U.S.-born African American adults ages 21 to 65 who are in good general health and took part in the GENE-FORECAST. Design: Participants will be screened with a medical history and physical exam. If needed, they will take a pregnancy test. These tests will be repeated during the study. Each day for 2 weeks, participants will take 3 capsules that contain either placebo or salt. Then they will take no pills for 3 weeks. Then they will take placebo or salt capsules for 2 more weeks. Participants will talk about the foods and drinks they have consumed over the past 24 hours. They will take a survey about their physical activity and sleep. Participants will complete taste tasks to obtain their responses to sweetness or saltiness. Sucrose and salt detection thresholds and preferences will be assessed. Participants will give blood and urine samples. Saliva samples will be collected from their mouth by passive drool or by spitting into a sterile tube. Skin samples will be collected from behind their ears and the inner part of their elbow, using sterile swabs. Participants will get kits to collect stool samples at home. Participants will have 4 study visits over 7 weeks.
Primary Outcome
Mean change in vascular function was measured by Pulse Wave Velocity (PWV) using the SphygmoCor XCEL. PWV was determined by recording the pulse waves of the carotid and femoral arteries and calculating the ratio of the distance between the pulse measuring sites to the time delay between the carotid and femoral pulse waves. The distance was measured with a non-stretchable tape from the suprasternal notch to the carotid site and from the suprasternal notch to the femoral site. The former distance
Interventions
- OTHER Placebo
- OTHER Sodium Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-01-22 |
| Est. Completion | 2022-07-08 |
| Phase | NA |
What the finished NCT04717336 record still lists
NCT04717336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04717336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04717336 about?
NCT04717336 is a clinical study titled "Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENE-FORECAST): Sodium Intervention Trial (SIT)". 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. Researchers want to learn more about why African Americans seem to have the greatest benefit from ce...
What is the current status of trial NCT04717336?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2021-01-22. Estimated completion is 2022-07-08.
What interventions are being tested in trial NCT04717336?
The interventions under investigation include: Placebo (OTHER), Sodium Chloride (OTHER).
Who is sponsoring clinical trial NCT04717336?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04717336's enrollment target sits among peer trials
36 1541st of 2000 higher than 437 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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