Blood Pressure Clinical Trial
Official title:
Effects of Yoga on Pressor and Endothelial Function in Responses to Sodium Loading in African American Adults
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 |
Verified date | April 2024 |
Source | Texas State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
United States | Cardiovascular Physiology Laboratory-Texas State University | San Marcos | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas State University |
United States,
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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