- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05353270
Effects of Yoga on Sodium-induced Pressor Responses in African American Adults
April 9, 2024 updated by: Stacy Hunter, Texas State University
Effects of Yoga on Pressor and Endothelial Function in Responses to Sodium Loading in African American Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Marcos, Texas, United States, 78666
- Cardiovascular Physiology Laboratory-Texas State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga
Yoga sessions (35 minutes each) will be performed 5 times weekly for 4 weeks.
|
Yoga sessions will be completed 5 times per week for 4 weeks.
|
|
Other: Waitlist control
Waitlisted participants will maintain their normal diet and exercise patterns for 4 weeks prior to rerandomization to the yoga group.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
|
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.
|
Measurements will be completed after 3 days of low- and 3 days of high-sodium intake at baseline and at week 4.
|
|
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.
|
Measurements will be completed after 3 days of low- and 3 days of high-sodium intake at baseline and at week 4.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Measurements will be completed after 3 days of low- and 3 days of high-sodium intake at baseline and at week 4.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
July 1, 2022
Study Completion (Actual)
July 1, 2022
Study Registration Dates
First Submitted
April 25, 2022
First Submitted That Met QC Criteria
April 25, 2022
First Posted (Actual)
April 29, 2022
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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