Exercise, Hypertension, and Gut Dysbiosis in African Americans

April 8, 2026 updated by: Marc D Cook, North Carolina Agriculture & Technical State University

Effects of Exercise on Hypertension and Gut Dysbiosis in African Americans

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

African Americans (AA) have the greatest burden of hypertension and elucidating the pathogenesis of this racial disparity is important for amending treatment strategies. Gut microbial dysbiosis has been linked to hypertension and has been characterized as low microbial composition of short chain fatty acid (SCFA) producing microbes. Reduced gut SCFA production has been observed in AA with disease, such as glucose intolerance and vitamin deficiency, and may be related to the pathogenesis of hypertension in this group. Preliminary data show that aerobic exercise improves the gut microbial profile and increases SCFA production in animal models and humans. Additional preliminary data show that the SCFA butyrate attenuates dysfunction in AA endothelial cells suggesting a role for SCFA in endothelial/vascular function. The proposed studies have been constructed to fill a critical void in our understanding of the pathogenesis of hypertension in AA involving the gut microbiome. The investigators hypothesize that lower SCFA production is associated with blood pressure in AA and exercise will be effective in reducing blood pressure by coupling improvements in gut microbial health (↑SCFA production) and vascular health. The proposed research will: 1) quantify the relationship between gut dysbiosis (reduced gut and circulating SCFA) and blood pressure in AA with hypertension and 2) quantify the impact of aerobic exercise training on gut microbial community structure, identify adaptable SCFA microbes related to blood pressure, blood concentrations of SCFA, and blood pressure in AA. The research will provide novel insight into the pathogenesis of hypertension, particularly in the health disparate AA population, and will facilitate the development of future mechanistic studies to advance the clinical communities understanding of the "gut-vascular axis" concerning endothelial function and vascular disease in AA.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Greensboro, North Carolina, United States, 27411
        • North Carolina A&T State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hypertension (Exercise Intervention)
Participants with hypertension will submit blood and fecal samples for comparison to control participants with normal blood pressure. Control group will only donate fecal and blood samples and will not participate in the exercise intervention. Participants with hypertension will also perform 3 months of supervised aerobic exercise (5 days/week) and submit blood and fecal samples every 4 weeks until the completion of the study.
Behavioral: Exercise Training effect on Hypertension and Gut Dysbiosis
the proposed research will: 1) Characterize gut microbial community structure in AA with hypertension in two important compartments that make up the overall gut bacteria in the colon (fecal and colon mucosa); 2) Quantify the relationship between aerobic exercise training and gut bacteria to identify SCFA microbes that adapt to exercise and benefit BP.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 3 months
Expect a change in systolic and diastolic BP
3 months
Gut Dysbiosis
Time Frame: 3 months
Expect an change in microbial diversity and SCFA producing microbes
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
North Carolina Agriculture & Technical State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Cook, PhD, North Carolina Agriculture & Technical State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCarolinaATSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identifiable IPD will be made available for all primary and secondary data measures.

IPD Sharing Time Frame

Data will be available within 6 months of the end of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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