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Effects of Yoga on Sodium-induced Pressor Responses in African American Adults

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ClinicalTrials.gov Identifier: NCT05353270
Recruitment Status : Recruiting
First Posted : April 29, 2022
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Stacy Hunter, Texas State University

Study Description
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Brief Summary:
This investigation aims to determine the effects of a 4-week yoga intervention on sodium-induced pressor and endothelial function responses as well as markers of renal sodium handling in African American adults.

Condition or disease Intervention/treatment Phase
Blood Pressure Behavioral: Yoga Behavioral: Waitlist control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Yoga on Pressor and Endothelial Function in Responses to Sodium Loading in African American Adults
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Yoga
Yoga sessions (35 minutes each) will be performed 5 times weekly for 4 weeks.
 Behavioral: Yoga
Yoga sessions will be completed 5 times per week for 4 weeks.
Waitlist control
Waitlisted participants will maintain their normal diet and exercise patterns for 4 weeks prior to rerandomization to the yoga group.
 Behavioral: Waitlist control
Waitlisted participants will maintain their normal exercise and diet for 4 weeks. After follow up testing at week 4, participants will be rerandomized to the yoga condition.


Outcome Measures
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Primary Outcome Measures :
  1. Change in blood pressure from low- to high-sodium dietary conditions [ Time Frame: Measurements will be completed after 3 days of low and 3 days of high sodium intake at baseline and after 4 weeks for both conditions. ]
    Blood pressure will be measured after 3 days of very low sodium and 3 days of high sodium intake.

  2. Change in endothelial function from low- to high-sodium dietary conditions. [ Time Frame: Measurements will be completed after 3 days of low- and 3 days of high-sodium intake at baseline and at week 4. ]
    Flow-mediated dilation will be measured via ultrasound imaging of the upper arm after 3 days of low- and 3 days of high- sodium dietary conditions.

  3. Change in arterial stiffness from low- to high-sodium dietary conditions. [ Time Frame: Measurements will be completed after 3 days of low- and 3 days of high-sodium intake at baseline and at week 4. ]
    Cardio-ankle vascular index will be measured after 3 days of low- and 3 days of high-sodium intake.


Secondary Outcome Measures :
  1. Change in urinary sodium excretion from low- to high-sodium dietary conditions. [ Time Frame: Measurements will be completed after 3 days of low- and 3 days of high-sodium intake at baseline and at week 4. ]
    24-hour urine collection will be completed after 3 days of low- and after 3 days of high-sodium dietary conditions.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American
  • Adults ages 18-60 years

Exclusion Criteria:

  • pregnancy or within 60 days postpartum
  • having taken blood pressure (including diuretics beta-blockers, ACE inhibitors, angiotensin receptor blockers, and calcium channel blockers) or statin medications within the past 3 months (statins have been demonstrated to reduce oxidative stress which could impact flow-mediated dilation);
  • infection (viral or other) within the past 4 weeks;
  • having adrenal or endocrine tumors (these could impact BP);
  • renal disease defined as a glomerular filtration rate (GFR) of less than 60 (creatinine will be tested at initial screening and GFR will be calculated);
  • prior myocardial infarction; vii) known coronary heart disease;
  • personal history of stroke;
  • heart failure;
  • cardiac arrhythmias;
  • chronic obstructive pulmonary disease;
  • recent chest pain or dyspnea;
  • orthopedic limitations that preclude the execution of yoga postures;
  • current insulin dependence;
  • currently taking steroid medications;
  • currently undergoing chemotherapy or radiation;
  • having practiced yoga or yogic breathing techniques at least once weekly consistently within the past 3 months;
  • heat intolerance or electrolyte imbalances (hypo- or hyper-natremia or hypo- or hyper-kalemia).
Contacts and Locations
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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): NCT05353270


Locations
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United States, Texas
Cardiovascular Physiology Laboratory-Texas State University Recruiting
San Marcos, Texas, United States, 78666
Contact: Stacy D. Hunter, PhD    512-245-8046    s_h393@txstate.edu   
Contact       s_h393@txstate.edu   
Principal Investigator: Stacy D Hunter, PhD         
Sponsors and Collaborators
Texas State University
More Information
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Responsible Party: Stacy Hunter, Assistant Professor, Texas State University
ClinicalTrials.gov Identifier: NCT05353270    
Other Study ID Numbers: 7620
First Posted: April 29, 2022    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Stacy Hunter, Texas State University:
Blood pressure
Salt sensitivity