Effects of Breathing Patterns on Post-prandial Vascular Function

November 8, 2021 updated by: Texas State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Marcos, Texas, United States, 78666
        • Cardiovascular Physiology Laboratory-Texas State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in flow-mediated dilation
Time Frame: 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.
At baseline and at again 1, 2, 4 hours post high-fat meal consumption
Changes in oxidative stress
Time Frame: 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.
Once at baseline and again at 1, 2, and 4 hours post high-fat meal consumption.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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