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Phase 1 N=20 Randomized Quadruple-blind Other

Gut Butyrate and Blood Pressure in African Americans

Hypertension

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Mean Daytime Blood Pressure — 137.5; 132.9; 128.2 mmHg

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Sodium Butyrate 5 mmol (Drug); Sodium Butyrate 80 mmol (Drug)
Age
Adult · 30+ yrs
Sex
All
Sponsor
University of North Carolina, Chapel Hill
Primary completion
Nov 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Daytime Blood Pressure
137.5; 132.9; 128.2
PRIMARY
Mean Nighttime Blood Pressure
123.2; 116.2; 114.0
SECONDARY
Blood Butyrate Concentrations
143.88; 138.60; 149.89; 138.64; 151.57
SECONDARY
Interleukin-1 Beta (IL-1β) Concentration
NA; NA; NA

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.

Eligibility Criteria

Inclusion Criteria

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):

  • Provision of signed and dated informed consent form
  • Be an African American adult (man or woman) between 30 - 50 years of age with normal blood pressure (never diagnosed with hypertension) (systolic: 90-129 and diastolic: 60-89 mmHg).
  • Body Mass Index of 18.5-30 kg/m^2
  • Not have any other diagnosed cardiovascular disease
  • Not exercise regularly (Participate in less than 60 minutes of exercise/week)
  • Not be pregnant or be lactating
  • Be free of active diseases that affect your intestines (i.e., chronic constipation, diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, diabetes, hepatitis, HIV, and cancer)
  • Have not taken antibiotics in the past 3 months
  • Have not been regularly taking medications that impact intestinal function (i.e., laxatives, enemas, anti-diarrheal agents, narcotics, antacids, antispasmodics, antidepressants, anticonvulsants, antibiotics, herbals, homeopathy, and home remedies) or fiber supplements.
  • Have no plans of travel out of town during the study periods.
  • Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

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):

  • Provision of signed and dated informed consent form. Letter of clearance or signature of PCP on informed consent.
  • Be an African American adult (man or woman) between 30 - 50 years of age with stage-1 to stage-2 hypertension (systolic: 130-159 and diastolic: 80-99 mmHg).
  • Not taking any anti-hypertension medications (although the investigators may enroll individuals only taking a diuretic where resting BP levels are within the range of stage-1 hypertension: systolic BP 130-140 mmHg. Subjects can resume taking the diuretic after they remove the monitor).
  • Body Mass Index of 18.5-30 kg/m^2
  • Not have any other diagnosed cardiovascular disease
  • Not exercise regularly (Participate in less than 60 minutes of exercise/week)
  • Not be pregnant or be lactating
  • Be free of active diseases that affect your intestines (i.e., chronic constipation, diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, diabetes, hepatitis, HIV, and cancer)
  • Have not taken antibiotics in the past 3 months
  • Have not been regularly taking medications that impact intestinal function (i.e., laxatives, enemas, anti-diarrheal agents, narcotics, antacids, antispasmodics, antidepressants, diuretics, anticonvulsants, antibiotics, herbals, homeopathy, and home remedies) or fiber supplements.
  • Have no plans of travel out of town during the study periods.
  • Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria for both groups:

  • Exercise more than 60 minutes per week for more than 4 consecutive weeks.
  • Diagnosed with stroke, history of myocardial infarction (heart attack); liver, lung, or kidney diseases; peripheral vascular disease or cancer within the last 6 months.
  • Presence of metabolic disease (diabetes mellitus), inflammatory diseases (e.g., inflammatory bowel diseases, rheumatoid arthritis, and systemic lupus erythematosus); kidney stones or gallbladder problems; diagnosed liver, lung or kidney diseases;
  • Pregnancy, lactation, or actively
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04415333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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