HealthyNCT04864184
Effects of Breathing Patterns on Post-prandial Vascular Function
A study testing Normal physiologic rate breathing and Slow breathing in people with Healthy, run by Texas State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Normal physiologic rate breathing and Slow breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants ages 18-35 years
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Physiology Laboratory-Texas State University
San Marcos, Texas, 78666
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Normal physiologic rate breathing, Slow breathing
- Keywords
- Breathing, Yogic breathing
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal physiologic rate breathingBehavioural
2-minute breathing exercises will be completed every 15 minutes.
Slow breathingBehavioural
2-minute breathing exercises will be completed every 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Normal physiologic rate breathing; Behavioral: Slow breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Once at baseline and again at 1, 2, and 4 hours post high-fat meal consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Dec 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will complete 2 different sessions in random order.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864184
- Sponsor's protocol ID
- 7374
- Status last verified
- Nov 2021
- First submitted
- 29 Mar 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36344308
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Breathing Styles on Post High-Fat Meal Blood Vessel Function
- ClinicalTrials.gov ID
- NCT04864184
- Acronym / sponsor ID
- 7374
- Conditions
- Healthy
- Keywords
- Breathing, Yogic breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will complete 2 different sessions in random order.
| Arm | Type | Receives |
|---|---|---|
| Breathing intervention | Experimental | Behavioral: Normal physiologic rate breathing, Behavioral: Slow breathingParticipants will complete 2-minute breathing exercises following the Breathing App every 15 minutes during a 4-hour postprandial period following high-fat meal consumption. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male participants ages 18-35 years
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal physiologic rate breathing2-minute breathing exercises will be completed every 15 minutes. | Behavioural | Breathing intervention |
| Slow breathing2-minute breathing exercises will be completed every 15 minutes. | Behavioural | Breathing intervention |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Derived from this study: PubMed 36344308Hunter 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.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Active, not recruiting
Deliver-EE: Evaluating Effects of Meal Delivery
Healthy
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal physiologic rate breathing and Slow breathing in people with Healthy, run by Texas State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in flow-mediated dilation (time frame: At baseline and at again 1, 2, 4 hours post high-fat meal consumption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04864184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021; AzTrials last refreshed its copy on 29 Oct 2026.