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Gut Butyrate and Blood Pressure in African Americans

NCT04415333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-10-18

Study results available
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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.

Conditions

Interventions

DRUG

Sodium Butyrate 5 mmol

Enema-based delivery of 5 mmol butyrate in 0.9% saline, (60 mL total)

DRUG

Sodium Butyrate 80 mmol

Enema-based delivery of 80 mmol butyrate in 0.9% saline, (60 mL total)

Sponsors & Collaborators

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • North Carolina Agriculture & Technical State University

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Marc D Cook, PhD · North Carolina A&T State Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2021-11-01
Completion
2021-11-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415333 on ClinicalTrials.gov