Back to resultsEffects of Breathing Patterns on Post-prandial Vascular Function
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normal physiologic rate breathing
Slow breathing
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Breathing, Yogic breathing
Eligibility Criteria
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
Sites / Locations
- Cardiovascular Physiology Laboratory-Texas State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breathing intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04864184
First Posted
March 29, 2021
Last Updated
November 8, 2021
Sponsor
Texas State University
1. Study Identification
Unique Protocol Identification Number
NCT04864184
Brief Title
Effects of Breathing Patterns on Post-prandial Vascular Function
Official Title
The Effects of Different Breathing Styles on Post High-Fat Meal Blood Vessel Function
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Breathing, Yogic breathing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breathing intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Normal physiologic rate breathing
Intervention Description
2-minute breathing exercises will be completed every 15 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Slow breathing
Intervention Description
2-minute breathing exercises will be completed every 15 minutes.
Primary Outcome Measure Information:
Title
Change in flow-mediated dilation
Description
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.
Time Frame
At baseline and at again 1, 2, 4 hours post high-fat meal consumption
Title
Changes in oxidative stress
Description
Blood draws will be performed and samples will be processed and stored for future biochemical analysis of blood markers indicative of oxidative stress.
Time Frame
Once at baseline and again at 1, 2, and 4 hours post high-fat meal consumption.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cardiovascular Physiology Laboratory-Texas State University
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36344308
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Breathing Patterns on Post-prandial Vascular Function
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