A Phase 1 interventional study of Sodium Butyrate 5 mmol and Sodium Butyrate 80 mmol in Hypertension, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by University of North Carolina, Chapel Hill · Phase 1, Interventional, and Other
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.
Description: African Americans (AA) have the greatest burden of hypertension. Recently, gut microbial dysbiosis (a term that describes a poorly diverse gut microbial profile and lower short-chain fatty acid (SCFA) production) has been linked to hypertension and may be involved in the pathogenesis of hypertension in African Americans. African Americans have been reported to have lower gut SCFA and SCFA can reduce blood pressure. This is a proof of concept pilot study to determine the relationship between gut SCFA and blood pressure (BP). Delivery of butyrate to the gut will be via enema.
Objectives: The objectives of this research are to 1. Identify gut microbial taxa (SCFA butyrate-producing microbes) and circulating butyrate levels associated with hypertension via a cross-sectional design in AA without and with hypertension. 2. Quantify the relationship between SCFA (butyrate) absorption into the bloodstream and subsequent changes in blood pressure in a 24-hour period after delivering butyrate into the gut via enema.
Participants: African Americans males and females ages of 30-50 without hypertension (normal BP/healthy control; systolic BP: 90-129/ diastolic BP: 60-89mmHg) and with hypertension (systolic BP: 130-159 mmHg/ diastolic BP: 80-99 mmHg) that do not take anti-hypertension medication will be recruited.
Description of Study: There are 2 groups; control (without hypertension; BP: 90-129/60-89mmHg; 5 male/5 female, n=10) and experimental (with hypertension; BP 130-159/80-99 mmHg; 5 male/5 female, n=10). Normotensive participants (control group) will be age (±1 year) and sex-matched to hypertensive group participants. All participants (control and experimental groups; 5 male/5 female) will provide stool and blood samples, and complete 24-hour (hr) ambulatory blood pressure (ABP) monitoring to compare the abundance of fecal butyrate-producing microbes, circulating (blood) butyrate concentrations, and average blood pressure responses during the day and overnight. Individuals in the control group will only participate in donating stool (1-time) and a blood sample (1-time) and wearing a 24-hr ABP monitor (1-day). In a crossover blinded randomized controlled pilot study, the 10 hypertensive AA subjects (5 male/5 female) will be randomized to self-administer a sodium butyrate (80mmol butyrate in 0.9% saline, 60 ml total) or control (low dose) butyrate (5mmol butyrate 0.9%, 60 ml total) enema 1 week apart (7 days). Subjects will provide a stool sample before each study day (2 total), have their BP measured via ABP monitor, submit to a blood draws (pre-enema-baseline), self-administer the randomized enema, submit to a 30 min \& 60 min post-enema blood draw, and wear the 24-hour ABP monitor for the remainder of that day. Subjects will be provided with written and verbal instructions on how to self-administer the enema. The dietary supplement (sodium butyrate) will be compounded by a local pharmacy (Custom Care Pharmacy - 109 Pisgah Church Rd. Greensboro, NC) into an enema at the concentrations listed above.
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Normotensive (control subjects without hypertension): In order to be eligible to participate in this study, an individual must meet all of the following criteria (which will be assessed after an initial telephone interview and at Visit 1 (screening and consent visit):
Hypertension subjects not on anti-hypertension medication (intervention group). The pool of subjects that do not take hypertension medication may be limited. If a heavily medicated subject population is encountered, the investigators may include subjects taking diuretics only: In order to be eligible to participate in this study, an individual must meet all of the following criteria (which will be assessed after an initial telephone interview and at Visit 1 (screening and consent visit):
Exclusion Criteria for both groups:
After a randomized assignment in the crossover design, participants with hypertension will come to the testing office to self-administer the first enema with a concentration of 5 mmol sodium butyrate in a 0.9% saline solution (60 mL total). After a 7-days washout period, they will return to testing office to self-administer the other enema with a concentration of 80 mmol sodium butyrate in a 0.9% saline solution (60 mL total).
Drug: Sodium Butyrate 5 mmol · Drug: Sodium Butyrate 80 mmol
After a randomized assignment in the crossover design, participants with hypertension will come to the testing office to self-administer the first enema with a concentration of 80 mmol sodium butyrate in a 0.9% saline solution (60 mL total). After a 7-day washout period, they will return to the testing office to self-administer the other enema with a concentration of 5 mmol sodium butyrate in a 0.9% saline solution (60 mL total).
Drug: Sodium Butyrate 5 mmol · Drug: Sodium Butyrate 80 mmol
African Americans with normal blood pressure (control group) will not perform self-administration of the enema. They will submit to 1 blood draw and wear the 24-hour ambulatory blood pressure monitor for 1-day.
Enema-based delivery of 5 mmol butyrate in 0.9% saline, (60 mL total)
Enema-based delivery of 80 mmol butyrate in 0.9% saline, (60 mL total)
Mean Daytime Blood Pressure
Immediately following self-administration of butyrate enema, participants will be fitted with an ambulatory blood pressure monitor to be worn for 24 hours.
Time frame: approximately 16 hours post enema
Mean Nighttime Blood Pressure
Immediately following self-administration of butyrate enema, participants will be fitted with an ambulatory blood pressure monitor to be worn for 24 hours.
Time frame: approximately 8 hours post enema
Blood Butyrate Concentrations
Measure blood butyrate concentrations before, 30 minutes post, and 60 minutes post self-administration of the butyrate enemas
Time frame: up to 1 hour post enema
Interleukin-1 Beta (IL-1β) Concentration
Blood biomarker samples were collected for the inflammatory cytokine IL-1β.
Time frame: up to 1 hour post enema
| Milestone | Sodium Butyrate [5 mmol] First, Then Sodium Butyrate [80 mmol] | Sodium Butyrate [80 mmol] First, Then Sodium Butyrate [5 mmol] | Control |
|---|---|---|---|
| Started | 10 | 0 | 10 |
| Completed | 10 | 0 | 10 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sodium Butyrate [5 mmol] First, Then Sodium Butyrate [80 mmol] | Sodium Butyrate [80 mmol] First, Then Sodium Butyrate [5 mmol] | Control |
|---|---|---|---|
| Started | 10 | 0 | 10 |
| Completed | 10 | 0 | 10 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sodium Butyrate [5 mmol] First, Then Sodium Butyrate [80 mmol] | Sodium Butyrate [80 mmol] First, Then Sodium Butyrate [5 mmol] | Control |
|---|---|---|---|
| Started | 10 | 0 | 10 |
| Completed | 10 | 0 | 10 |
| Not completed | 0 | 0 | 0 |
Immediately following self-administration of butyrate enema, participants will be fitted with an ambulatory blood pressure monitor to be worn for 24 hours.
| mmHg | Sodium Butyrate [5 mmol] | Sodium Butyrate [80 mmol] | Control |
|---|---|---|---|
| Mean Daytime Blood Pressure | 137.5 ± 13.47 | 132.9 ± 12.64 | 128.2 ± 16.31 |
Immediately following self-administration of butyrate enema, participants will be fitted with an ambulatory blood pressure monitor to be worn for 24 hours.
| mmHg | Sodium Butyrate [5 mmol] | Sodium Butyrate [80 mmol] | Control |
|---|---|---|---|
| Mean Nighttime Blood Pressure | 123.2 ± 13.5 | 116.2 ± 10.9 | 114.0 ± 12.8 |
Measure blood butyrate concentrations before, 30 minutes post, and 60 minutes post self-administration of the butyrate enemas
| ng/mL | Sodium Butyrate [5 mmol] | Sodium Butyrate [80 mmol] | Control |
|---|---|---|---|
| Baseline | 143.88 ± 20.62 | 138.60 ± 16.84 | 149.89 ± 45.47 |
| 30 Minutes Post | 138.64 ± 11.29 | 151.57 ± 36.12 | — |
Blood biomarker samples were collected for the inflammatory cytokine IL-1β.
| pg/mL | Sodium Butyrate [5 mmol] | Sodium Butyrate [80 mmol] | Control |
|---|---|---|---|
| Interleukin-1 Beta (IL-1β) Concentration | NA ± NA | NA ± NA | NA ± NA |
Collected over During each 1-Day study visit through 24 hours post intervention administration and an additional 7 days after the final 1-Day study visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sodium Butyrate (5 mmol) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Sodium Butyrate (80 mmol) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Control | — | — | — |
No participants received random assignment to the 80 mmol intervention first.
| Age, Categorical(Participants) | Sodium Butyrate [5 mmol] First, Then Sodium Butyrate [80 mmol] | Sodium Butyrate [80 mmol] First, Then Sodium Butyrate [5 mmol] | Control | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 0 | 10 | 20 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Sodium Butyrate [5 mmol] First, Then Sodium Butyrate [80 mmol] | Sodium Butyrate [80 mmol] First, Then Sodium Butyrate [5 mmol] | Control | Total |
|---|---|---|---|---|
| Female | 5 | 0 | 6 | 11 |
| Male | 5 | 0 | 4 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Sodium Butyrate [5 mmol] First, Then Sodium Butyrate [80 mmol] | Sodium Butyrate [80 mmol] First, Then Sodium Butyrate [5 mmol] | Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 0 | 10 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sodium Butyrate [5 mmol] First, Then Sodium Butyrate [80 mmol] | Sodium Butyrate [80 mmol] First, Then Sodium Butyrate [5 mmol] | Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 0 | 10 | 20 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Sodium Butyrate [5 mmol] First, Then Sodium Butyrate [80 mmol] | Sodium Butyrate [80 mmol] First, Then Sodium Butyrate [5 mmol] | Control | Total |
|---|---|---|---|---|
| United States | 10 | 0 | 10 | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The investigators will share the informed consent and de-identified data set including fecal microbiome sequencing, blood pressure data, circulating butyrate levels in an online repository (Carolina Digital Repository).
Supporting information: Informed consent form
Time frame: 3-5 years after the completion of the primary endpoint.
Access criteria: Contact Dr. Marc Cook (mdcook@ncat.edu) at NC A\&T State University. The data set will be shared in the Carolina Digital repository.
Data sharing details ↗ · library.unc.edu
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