Blood PressureNCT05353270
Effects of Yoga on Sodium-induced Pressor Responses in African American Adults
A study testing Yoga in people with Blood Pressure, run by Texas State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- African American
- Adults ages 18-60 years
Who cannot join
- 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;
Show all 17Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Physiology Laboratory-Texas State University
San Marcos, Texas, 78666
About this study
Official title: 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.
- Conditions
- Blood Pressure
- Being tested
- Yoga, Waitlist control
- Keywords
- Blood pressure, Salt sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Yoga sessions will be completed 5 times per week for 4 weeks.
Waitlist controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Yoga sessions (35 minutes each) will be performed 5 times weekly for 4 weeks. Receives: Behavioral: Yoga |
| Waitlist control | Other | Waitlisted participants will maintain their normal diet and exercise patterns for 4 weeks prior to rerandomization to the yoga group. Receives: Behavioral: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Cardio-ankle vascular index will be measured after 3 days of low- and 3 days of high-sodium intake.
Measured: Measurements will be completed after 3 days of low- and 3 days of high-sodium intake at baseline and at week 4.
Secondary outcomes (1)
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.
Measured: Measurements will be completed after 3 days of low- and 3 days of high-sodium intake at baseline and at week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Sep 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacy Hunter, Texas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353270
- Sponsor's protocol ID
- 7620
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hunter SD, Kavouras SA, Rahimi M. Exploring heated exercise as a means of preventing the deleterious effects of high-sodium intake in Black women. Am J Physiol Heart Circ Physiol. 2023 Jun 1;324(6):H833-H839. doi: 10.1152/ajpheart.00699.2022. Epub 2023 Apr 7.
PubMed 37027326
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga on Pressor and Endothelial Function in Responses to Sodium Loading in African American Adults
- ClinicalTrials.gov ID
- NCT05353270
- Acronym / sponsor ID
- 7620
- Conditions
- Blood Pressure
- Keywords
- Blood pressure, Salt sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: YogaYoga sessions (35 minutes each) will be performed 5 times weekly for 4 weeks. |
| Waitlist control | Other | Behavioral: Waitlist controlWaitlisted participants will maintain their normal diet and exercise patterns for 4 weeks prior to rerandomization to the yoga group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- African American
- Adults ages 18-60 years
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaYoga sessions will be completed 5 times per week for 4 weeks. | Behavioural | Yoga |
| Waitlist controlWaitlisted 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. | Behavioural | Waitlist control |
Primary outcome
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.
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 37027326Hunter SD, Kavouras SA, Rahimi M. Exploring heated exercise as a means of preventing the deleterious effects of high-sodium intake in Black women. Am J Physiol Heart Circ Physiol. 2023 Jun 1;324(6):H833-H839. doi: 10.1152/ajpheart.00699.2022. Epub 2023 Apr 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Blood Pressure, run by Texas State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05353270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.