NCT05353270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

April 25, 2022

Last Update Submit

April 9, 2024

Conditions

Blood Pressure

Keywords

Blood pressureSalt sensitivity

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (1)

  • Change in urinary sodium excretion from low- to 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.

Study Arms (2)

Yoga

EXPERIMENTAL

Yoga sessions (35 minutes each) will be performed 5 times weekly for 4 weeks.

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.

Behavioral: Waitlist control

Interventions

YogaBEHAVIORAL

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

Yoga
Waitlist controlBEHAVIORAL

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.

Waitlist control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • African American
  • Adults ages 18-60 years

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Physiology Laboratory-Texas State University

San Marcos, Texas, 78666, United States

Location

Related Publications (1)

  • 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.

    PMID: 37027326DERIVED

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

September 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

US(1)