Exercise, Hypertension, and Gut Dysbiosis in African Americans
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ClinicalTrials.gov Identifier: NCT03897777 |
Recruitment Status :
Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Behavioral: Exercise Training effect on Hypertension and Gut Dysbiosis | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Effects of Exercise on Hypertension and Gut Dysbiosis in African Americans |
Estimated Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2021 |

Arm | Intervention/treatment |
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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.
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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. |
- Blood Pressure [ Time Frame: 3 months ]Expect a change in systolic and diastolic BP
- Gut Dysbiosis [ Time Frame: 3 months ]Expect an change in microbial diversity and SCFA producing microbes

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Ages Eligible for Study: | 30 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897777
Contact: Marc Cook, PhD | 336-285-3547 | mdcook@ncat.edu |
United States, North Carolina | |
North Carolina A&T State University | Not yet recruiting |
Greensboro, North Carolina, United States, 27411 | |
Contact: Stephanie Evans sevans3@ncat.edu | |
Principal Investigator: Marc Cook, PhD |
Principal Investigator: | Marc Cook, PhD | North Carolina Agriculture & Technical State University |
Documents provided by Marc D Cook, North Carolina Agriculture & Technical State University:
Responsible Party: | Marc D Cook, Assistant Professor of Exercise Immunology, North Carolina Agriculture & Technical State University |
ClinicalTrials.gov Identifier: | NCT03897777 History of Changes |
Other Study ID Numbers: |
NCarolinaATSU |
First Posted: | April 1, 2019 Key Record Dates |
Last Update Posted: | April 1, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identifiable IPD will be made available for all primary and secondary data measures. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data will be available within 6 months of the end of the study |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Blood pressure Gut dysbiosis Exercise training |
Hypertension Dysbiosis Vascular Diseases Cardiovascular Diseases Pathologic Processes |