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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05353270
Other study ID # 7620
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date July 1, 2022

Study information

Verified date April 2024
Source Texas State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Yoga
Yoga sessions will be completed 5 times per week for 4 weeks.
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.

Locations

Country Name City State
United States Cardiovascular Physiology Laboratory-Texas State University San Marcos Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in blood pressure from low- to high-sodium dietary 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.
Primary Change in endothelial function from low- to high-sodium dietary conditions. 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.
Primary Change in arterial stiffness from low- to high-sodium dietary conditions. 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 Change in urinary sodium excretion from low- to high-sodium dietary conditions. 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.
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