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NCT04415333 · ClinicalTrials.gov registry record · Phase 1
Gut Butyrate and Blood Pressure in African Americans
A Phase 1 study of Hypertension, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04415333: Completed Phase 1 study of Hypertension, sponsored by University of North Carolina, Chapel Hill.
NCT04415333 is a Phase 1 study of Hypertension that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 20 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04415333, a Phase 1 study of Hypertension, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
African Americans have the greatest burden of hypertension. Recently, the short-chain fatty acid, butyrate, has been reported to have some effect on blood pressure. Butyrate is not normally ingested since it is made by bacteria in the gut as a byproduct of fiber fermentation. In this proof of concept study, the investigators will investigate the effect of butyrate absorbed in the gut (via the participant self-administering an enema with butyrate) has on blood pressure.
Primary Outcome
Immediately following self-administration of butyrate enema, participants will be fitted with an ambulatory blood pressure monitor to be worn for 24 hours.
Conditions Studied
Interventions
- DRUG Sodium Butyrate 5 mmol
- DRUG Sodium Butyrate 80 mmol
Study Locations (1)
North Carolina
- NC A&T State University - Greensboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-07-08 |
| Est. Completion | 2021-11-02 |
| Phase | Phase 1 |
What the finished NCT04415333 record still lists
NCT04415333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Sodium Butyrate 5 mmol is the first listed.
NCT04415333 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04415333 about?
NCT04415333 is a clinical study titled "Gut Butyrate and Blood Pressure in African Americans". African Americans have the greatest burden of hypertension. Recently, the short-chain fatty acid, butyrate, has been reported to have some effect on blood pressure. Butyrate is not normally ingested since it is made by bacteria in the gut as a byproduct of fiber fermentation. In this proof of concep...
What is the current status of trial NCT04415333?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-07-08. Estimated completion is 2021-11-02.
What conditions does trial NCT04415333 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT04415333?
The interventions under investigation include: Sodium Butyrate 5 mmol (DRUG), Sodium Butyrate 80 mmol (DRUG).
Who is sponsoring clinical trial NCT04415333?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04415333 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04415333's enrollment target sits among peer trials
20 438th of 470 higher than 24 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension 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.
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