Gut Butyrate and Blood Pressure in African Americans

Completed · Phase 1

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT04415333

Run by

University of North Carolina, Chapel Hill

People needed

20

Starts

2021-07-08

Expected to finish

2021-11-02

Last updated by the study team

2023-10-18

Who can join

Age: 30 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• NC A&T State University — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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