Effects of Breathing Patterns on Post-prandial Vascular Function

Sponsor

Texas State University (Other)

Overall Status

Completed

CT.gov ID

NCT04864184

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Normal physiologic rate breathing Behavioral: Slow breathing	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Each participant will complete 2 different sessions in random order.Each participant will complete 2 different sessions in random order.

Masking:

None (Open Label)

Masking Description:

Participants will be blinded to the respiratory rates being practiced during each study visit. Breathing patterns will be completed in random order.

Primary Purpose:

Treatment

Official Title:

The Effects of Different Breathing Styles on Post High-Fat Meal Blood Vessel Function

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breathing intervention 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 breathing 2-minute breathing exercises will be completed every 15 minutes. Behavioral: Slow breathing 2-minute breathing exercises will be completed every 15 minutes.

Arm

Intervention/Treatment

Experimental: Breathing intervention

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 breathing

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

Behavioral: Slow breathing

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

Outcome Measures

Primary Outcome Measures

Change in flow-mediated dilation [At baseline and at again 1, 2, 4 hours post high-fat meal consumption]
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.
Changes in oxidative stress [Once at baseline and again at 1, 2, and 4 hours post high-fat meal consumption.]
Blood draws will be performed and samples will be processed and stored for future biochemical analysis of blood markers indicative of oxidative stress.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

• Male participants ages 18-35 years

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Physiology Laboratory-Texas State University	San Marcos	Texas	United States	78666

Sponsors and Collaborators

Texas State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Texas State University

ClinicalTrials.gov Identifier:

NCT04864184

Other Study ID Numbers:

7374

First Posted:

Apr 28, 2021

Last Update Posted:

Nov 9, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Texas State University

Breathing

Yogic breathing

Additional relevant MeSH terms:

Respiratory Aspiration

Study Results

No Results Posted as of Nov 9, 2021