Exercise, Hypertension, and Gut Dysbiosis in African Americans

NCT03897777 | Active Not Recruiting

• 1 other identifier: NCarolinaATSU
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Blood pressure; Gut dysbiosis; Exercise training

Outcome Measures

Primary Outcomes (2)

• Blood Pressure

  Expect a change in systolic and diastolic BP

  3 months

• Gut Dysbiosis

  Expect an change in microbial diversity and SCFA producing microbes

  3 months

Study Arms (1)

Hypertension (Exercise Intervention)

EXPERIMENTAL

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

Interventions

Exercise Training effect on Hypertension and Gut Dysbiosis BEHAVIORAL

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.

Hypertension (Exercise Intervention)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sedentary (regular aerobic exercise frequency ≤2 times per week and duration ≤20 minutes per session; sedentary profession);
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• North Carolina Agriculture & Technical State University: lead

Study Sites (1)

North Carolina A&T State University

Greensboro, North Carolina, 27411, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marc Cook, PhD

  North Carolina Agriculture & Technical State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Exercise Immunology

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: April 1, 2019
• Study Start: June 1, 2019
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available within 6 months of the end of the study

Locations

US (1)