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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04864184
Other study ID # 7374
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date September 30, 2021

Study information

Verified date November 2021
Source Texas State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Normal physiologic rate breathing
2-minute breathing exercises will be completed every 15 minutes.
Slow breathing
2-minute breathing exercises will be completed every 15 minutes.

Locations

Country Name City State
United States Cardiovascular Physiology Laboratory-Texas State University San Marcos Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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.
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