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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

Tracking Information
First Submitted Date  ICMJE January 26, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date April 1, 2019
Estimated Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise, Hypertension, and Gut Dysbiosis in African Americans
Official Title  ICMJE Effects of Exercise on Hypertension and Gut Dysbiosis in African Americans
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Hypertension
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Exercise Training effect on Hypertension and Gut Dysbiosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marc Cook, PhD 336-285-3547 mdcook@ncat.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03897777
Other Study ID Numbers  ICMJE NCarolinaATSU
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will be available within 6 months of the end of the study
Responsible Party Marc D Cook, North Carolina Agriculture & Technical State University
Study Sponsor  ICMJE North Carolina Agriculture & Technical State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc Cook, PhD North Carolina Agriculture & Technical State University
PRS Account North Carolina Agriculture & Technical State University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP