Exercise, Hypertension, and Gut Dysbiosis in African Americans (NCT03897777) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Exercise, Hypertension, and Gut Dysbiosis in African Americans
United States36 participantsStarted 2019-06-01
Plain-language summary
African Americans have the greatest burden of endothelial dysfunction and 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. Exercise reduces blood pressure and improves gut dysbiosis (increases SCFA) and likely couples' improvements in gut microbial health and vascular function to reduce blood pressure. Thus, the goals of this research are to fill a critical void concerning the interaction of gut dysbiosis, hypertension, and utilizing exercise to identify gut microbial adaptations that accompany a reduction in blood pressure. The short-term implications of this work will advance the clinical communities understanding of the relationship between dysbiosis and the pathogenesis of hypertension in African Americans, while long term implications will promote identifying adaptable gut microbes associated with vascular health to aid in amending treatment strategies for hypertension.
Who can participate
Age range
30 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Sedentary (regular aerobic exercise frequency ≤2 times per week and duration ≤20 minutes per session; sedentary profession);
* 30-50 years of age;
* Control normotensive (systolic BP: 90-120 mmHg/diastolic BP: 60-80 mmHg)
* Elevated to Stage 1 Hypertension (systolic BP: 120-129 mmHg/diastolic BP: 80-89 mmHg) and/or stage 1 hypertension (systolic BP: 130-159 mmHg/diastolic BP: 90-99 mmHg).
Exclusion Criteria
Diagnosed with any of the following:
* Uncontrolled hypertension, stroke, history of heart attack, heart disease;
* Metabolic disease (diabetes mellitus);
* Inflammatory diseases (inflammatory bowel disease(s), rheumatoid arthritis, and systemic lupus erythematosus);
* Kidney stones or gallbladder problems;
* Kidney disease;
* Liver disease;
* Lung disease;
* Cancer within the previous 6 months; (11) pregnant females;
* Peripheral vascular disease;
* Taking hypertension medications or those known to affect inflammation or metabolic function (anti-inflammatories, statins, thyroid medication) in the past 1 month;
* Currently smoking;
* Other conditions that would exclude vigorous exercise (\>2mV ST-segment depression or CVD signs and symptoms during the screening graded exercise test).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood Pressure
Timeframe: 3 months
2
Gut Dysbiosis
Timeframe: 3 months
Trial details
NCT IDNCT03897777
SponsorNorth Carolina Agriculture & Technical State University