Gut Butyrate and Blood Pressure in African Americans
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT04415333 ↗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
| Outcome | Result | p-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
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
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.