Adults 30 to 50, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Daytime Blood PressurePrimary· approximately 16 hours post enema
Immediately following self-administration of butyrate enema, participants will be fitted with an ambulatory blood pressure monitor to be worn for 24 hours.
Group
Value
95% CI
Sodium Butyrate [5 mmol]
137.5
± 13.47
Sodium Butyrate [80 mmol]
132.9
± 12.64
Control
128.2
± 16.31
Mean Nighttime Blood PressurePrimary· approximately 8 hours post enema
Immediately following self-administration of butyrate enema, participants will be fitted with an ambulatory blood pressure monitor to be worn for 24 hours.
Group
Value
95% CI
Sodium Butyrate [5 mmol]
123.2
± 13.5
Sodium Butyrate [80 mmol]
116.2
± 10.9
Control
114.0
± 12.8
Blood Butyrate ConcentrationsSecondary· up to 1 hour post enema
Measure blood butyrate concentrations before, 30 minutes post, and 60 minutes post self-administration of the butyrate enemas
Baseline
Group
Value
95% CI
Sodium Butyrate [5 mmol]
143.88
± 20.62
Sodium Butyrate [80 mmol]
138.60
± 16.84
Control
149.89
± 45.47
30 Minutes Post
Group
Value
95% CI
Sodium Butyrate [5 mmol]
138.64
± 11.29
Sodium Butyrate [80 mmol]
151.57
± 36.12
Interleukin-1 Beta (IL-1β) ConcentrationSecondary· up to 1 hour post enema
Blood biomarker samples were collected for the inflammatory cytokine IL-1β.
Group
Value
95% CI
Sodium Butyrate [5 mmol]
NA
± NA
Sodium Butyrate [80 mmol]
NA
± NA
Control
NA
± NA
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07413159 — The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans A
· NA
· recruiting
NCT07361276 — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care S
· recruiting
NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors
· NA
· recruiting
NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia
· Phase 2
· recruiting
NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension
· NA
· recruiting
Other University of North Carolina, Chapel Hill trials
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 18 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04415333.