NCT04864184

Brief Summary

The purpose of this study is investigate the effects of two different breathing styles on postprandial vascular function and oxidative stress markers. Participants will complete 2 breathing conditions in random order.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2020

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

December 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

March 29, 2021

Last Update Submit

November 8, 2021

Conditions

Keywords

BreathingYogic breathing

Outcome Measures

Primary Outcomes (2)

  • Change in flow-mediated dilation

    Ultrasound-derived images of the brachial artery pre- and post-suprasystolic cuff inflation will yield flow-mediated dilation values. These are indices are endothelium-dependent vasodilation.

    At baseline and at again 1, 2, 4 hours post high-fat meal consumption

  • Changes in oxidative stress

    Blood draws will be performed and samples will be processed and stored for future biochemical analysis of blood markers indicative of oxidative stress.

    Once at baseline and again at 1, 2, and 4 hours post high-fat meal consumption.

Study Arms (1)

Breathing intervention

EXPERIMENTAL

Participants will complete 2-minute breathing exercises following the Breathing App every 15 minutes during a 4-hour postprandial period following high-fat meal consumption.

Behavioral: Normal physiologic rate breathingBehavioral: Slow breathing

Interventions

2-minute breathing exercises will be completed every 15 minutes.

Breathing intervention
Slow breathingBEHAVIORAL

2-minute breathing exercises will be completed every 15 minutes.

Breathing intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male participants ages 18-35 years

You may not qualify if:

  • Infection within the previous 4 weeks
  • Renal disorders
  • Any cardiovascular disorders such as prior myocardial infarction, known coronary artery disease, personal history of stroke, heart failure, cardiac arrhythmias
  • Chronic obstructive pulmonary disease
  • Diabetes
  • Inflammatory bowel disease
  • HIV, rheumatoid arthritis, chronic or other inflammatory conditions
  • Currently taking steroids or other anti-inflammatory medications
  • Current use of nonsteroidal anti-inflammatory drugs
  • Smoking
  • Stage 2 hypertension or higher (systolic BP of 140 mm Hg or higher and/or diastolic BP of 90 mm Hg or higher)
  • Lactose intolerance

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, Bernardi L, McAllister MJ, John D, Rahimi M, Lopez MR. Device-guided slow breathing alters postprandial oxidative stress in young adult males: A randomized sham-controlled crossover trial. Nutr Metab Cardiovasc Dis. 2023 Jan;33(1):203-209. doi: 10.1016/j.numecd.2022.10.002. Epub 2022 Oct 10.

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants will be blinded to the respiratory rates being practiced during each study visit. Breathing patterns will be completed in random order.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Each participant will complete 2 different sessions in random order.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 28, 2021

Study Start

December 1, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

November 9, 2021

Record last verified: 2021-11

Locations