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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
Sponsor:
Information provided by (Responsible Party):
Marc D Cook, North Carolina Agriculture & Technical State University

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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Exercise Training effect on Hypertension and Gut Dysbiosis Not Applicable

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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: 3 months ]
    Expect a change in systolic and diastolic BP

  2. 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
Criteria

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).

Information from the National Library of Medicine

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


Contacts
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Contact: Marc Cook, PhD 336-285-3547 mdcook@ncat.edu

Locations
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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         
Sponsors and Collaborators
North Carolina Agriculture & Technical State University
Investigators
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Principal Investigator: Marc Cook, PhD North Carolina Agriculture & Technical State University
  Study Documents (Full-Text)

Documents provided by Marc D Cook, North Carolina Agriculture & Technical State University:
Informed Consent Form  [PDF] June 25, 2018


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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marc D Cook, North Carolina Agriculture & Technical State University:
Blood pressure
Gut dysbiosis
Exercise training
Additional relevant MeSH terms:
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Hypertension
Dysbiosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes