Weight LossBreathingNCT05488574
Effects of Novel Breathing Behavior Modification Yoga Positioning Integrated Program on Weight Loss
A study testing Deep breathing with Yoga positioning in people with Weight Loss and Metabolism, run by Touro University Nevada at 1 site in United States.
Trial summary
This study is to evaluate the physical and cognitive effects of a 15 min per day novel breathing and mindfulness moving-meditation program on metabolism, cognition, and emotion health. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Metabolism
- What is being tested?
- Deep breathing with Yoga positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2022to 23 Nov 2022
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Body Mass Index at or above 27
- Stable weight past 3 months
- able to stand for 10 minutes
- Able to lift arms overhead
Who cannot join
- Chronic Obstructive Pulmonary Disease
- acute respiratory distress
- supplemental oxygen use
- inability to stand, flex trunk, or move arms overhead
- Pacemaker implant
- Taking beta blocking medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Novel Breathing, Behavior Modification, Yoga Positioning Integrated Program on Weight Loss.
This study is to evaluate the physical and cognitive effects of a 15 min per day novel breathing and mindfulness moving-meditation program on metabolism, cognition, and emotion health. It is thought that the breathing and movement program will increase basal metabolism, facilitate fat loss, and decrease depressive behaviors. Anthropometric, blood chemistries, and cognitive measures of depression, sleep, and hunger will be measured over a two-month interventional program.
Read the detailed description
Subjects will be randomized into two groups, an active group and control group. For the first 30 days, the active group will follow the movement/breath program and the controls will be instructed not to change their lifestyle (no change in diet, and no change in exercise / physical activities). The technicians taking measurements will be blinded as to which participants are actives vs controls. The following 30 days' intervention will consist of continuing the Phase I interventions combined with implementing the behavior change strategies on 2 to 3 habit changes self-selected from a list of 30 top "bad habits" that contribute to weight gain and undermine one's ability to lose weight with the control group again not changing any lifestyle activities. Measurements: Measurements will be taken at the start (baseline), 10 days, 30 days, and 60 days of intervention with the measurement days scheduled to evaluate people completing 10 full days of the program, 30 full days, and 60 full days respectively. Measurements taken at each interval to include weight, body composition (lean mass \& fat percentages), anthropometric measurements (umbilicus, hips, right thigh, right upper arm), pO2, resting heart rate, HRV, blood pressure, pulmonary health (i.e., O2 max, spirometry), hunger, sleep, and depression rating (by self-assessment survey scale). Serum chemistry for basic metabolic panel, inflammatory markers, and lipids, hematology for oxygen carrying capacity and gross immune response, Human Growth Factor production via ELISA quantification, imaging ultrasound to measure subcutaneous fat thickness at the areas of girth measurements, DEXA for overall and targeted areas body composition, and resting metabolic rate via oxygen plethysmograph.
- Conditions
- Weight Loss, Metabolism
- Being tested
- Deep breathing with Yoga positioning
- Keywords
- metabolism, obesity, mentation
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep breathing with Yoga positioningOther
Also called Novel breathing and mindfulness moving-meditation.
Deep breathing with yoga positioning 10min in morning, 1 minute noon, and 1 minute evening (diner)
| Study group | Role | What they receive |
|---|---|---|
| Deep breathing with Yoga positioning | Experimental | subjects participating in breathing and moving meditation program. 12 minutes daily of deep breathing and yoga positioning first 30 days, then continuation of breathing and positioning and self-directed, mentored, behavior modification activities the second 30 days. Receives: Other: Deep breathing with Yoga positioning |
| Control | No intervention | No changes in lifestyle or activities over the 60 day period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rom baseline in body Weight
Weight in kilograms
Measured: Baseline, 10 days, 30 days, and 60 days.
Change from baseline in Body Mass Index
DEXA Measurement of % total fat
Measured: Baseline, 10 days, 30 days, and 60 days.
Secondary outcomes (4)
Human Growth Hormone - Metabolic rate
Measurement of Human Growth Hormone
Measured: baseline, 10 days, 30 days, 60 days
VO2 at rest, Oxygen consumption at rest-resting metabolic rate(RMR)
Oxygen consumption via oxygen plethysmograph
Measured: Baseline, 10 days, 30 days, and 60 days.
Respiratory quotient (RQ) - metabolic rate
CO2 eliminated/O2 consumed
Measured: Baseline, 10 days, 30 days, and 60 days.
lipid panel - metabolic rate
Total cholesterol, high density lipids, low density lipids, triglycerides
Measured: Baseline, 10 days, 30 days, and 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start20 Sep 2022
- Primary completion23 Nov 2022 (estimated)
- Study completion23 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized control group, investigator blinded, repeated measure interventional program.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Touro University Nevada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Laymon, Touro University Nevada
- Investigators
- Michael S Laymon, DSc, PT, Principal investigator, Touro University Nevada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488574
- Sponsor's protocol ID
- ML-CHHS-22-338
- Acronym
- Breathing
- Status last verified
- Oct 2022
- First submitted
- 28 Jul 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect privacy of subjects, Data will be reported as cumulative without individual participant data. In the event of potential health adverse disease process IPD may be shared with individuals' consent to their designated, licensed, healthcare provider.
Publications
Sato K, Kawamura T, Yamagiwa S. The "Senobi" breathing exercise ameliorates depression in obese women through up-regulation of sympathetic nerve activity and hormone secretion. Biomed Res. 2011 Apr;32(2):175-80. doi: 10.2220/biomedres.32.175.
PubMed 21551954Sato K, Kawamura T, Yamagiwa S. The "Senobi" breathing exercise is recommended as first line treatment for obesity. Biomed Res. 2010 Aug;31(4):259-62. doi: 10.2220/biomedres.31.259.
PubMed 20834183Sato K, Kawamura T, Abo T. "Senobi" stretch ameliorates asthma symptoms by restoring autonomic nervous system balance. J Investig Med. 2010 Dec;58(8):968-70. doi: 10.231/JIM.0b013e3181f9167b.
PubMed 20930645Nivethitha L, Mooventhan A, Manjunath NK. Evaluation of Cardiovascular Functions during the Practice of Different Types of Yogic Breathing Techniques. Int J Yoga. 2021 May-Aug;14(2):158-162. doi: 10.4103/ijoy.IJOY_61_20. Epub 2021 May 10.
PubMed 34188389Nivethitha L, Mooventhan A, Manjunath NK, Bathala L, Sharma VK. Cerebrovascular Hemodynamics During the Practice of Bhramari Pranayama, Kapalbhati and Bahir-Kumbhaka: An Exploratory Study. Appl Psychophysiol Biofeedback. 2018 Mar;43(1):87-92. doi: 10.1007/s10484-017-9387-8.
PubMed 29188396
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Novel Breathing, Behavior Modification, Yoga Positioning Integrated Program on Weight Loss.
- ClinicalTrials.gov ID
- NCT05488574
- Acronym / sponsor ID
- Breathing / ML-CHHS-22-338
- Conditions
- Weight Loss, Metabolism
- Keywords
- metabolism, obesity, mentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Touro University NevadaUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 23 Nov 2022 (estimated)
- Study completion
- 23 Nov 2022 (estimated)
- First posted
- 4 Aug 2022 (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.
This study is to evaluate the physical and cognitive effects of a 15 min per day novel breathing and mindfulness moving-meditation program on metabolism, cognition, and emotion health. It is thought that the breathing and movement program will increase basal metabolism, facilitate fat loss, and decrease depressive behaviors. Anthropometric, blood chemistries, and cognitive measures of depression, sleep, and hunger will be measured over a two-month interventional program.
Detailed description
Subjects will be randomized into two groups, an active group and control group. For the first 30 days, the active group will follow the movement/breath program and the controls will be instructed not to change their lifestyle (no change in diet, and no change in exercise / physical activities). The technicians taking measurements will be blinded as to which participants are actives vs controls. The following 30 days' intervention will consist of continuing the Phase I interventions combined with implementing the behavior change strategies on 2 to 3 habit changes self-selected from a list of 30 top "bad habits" that contribute to weight gain and undermine one's ability to lose weight with the control group again not changing any lifestyle activities. Measurements: Measurements will be taken at the start (baseline), 10 days, 30 days, and 60 days of intervention with the measurement days scheduled to evaluate people completing 10 full days of the program, 30 full days, and 60 full days respectively. Measurements taken at each interval to include weight, body composition (lean mass \& fat percentages), anthropometric measurements (umbilicus, hips, right thigh, right upper arm), pO2, resting heart rate, HRV, blood pressure, pulmonary health (i.e., O2 max, spirometry), hunger, sleep, and depression rating (by self-assessment survey scale). Serum chemistry for basic metabolic panel, inflammatory markers, and lipids, hematology for oxygen carrying capacity and gross immune response, Human Growth Factor production via ELISA quantification, imaging ultrasound to measure subcutaneous fat thickness at the areas of girth measurements, DEXA for overall and targeted areas body composition, and resting metabolic rate via oxygen plethysmograph.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized control group, investigator blinded, repeated measure interventional program.
| Arm | Type | Receives |
|---|---|---|
| Deep breathing with Yoga positioning | Experimental | Other: Deep breathing with Yoga positioningsubjects participating in breathing and moving meditation program. 12 minutes daily of deep breathing and yoga positioning first 30 days, then continuation of breathing and positioning and self-directed, mentored, behavior modification activities the second 30 days. |
| Control | No intervention | –No changes in lifestyle or activities over the 60 day period. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 years
- Body Mass Index at or above 27
- Stable weight past 3 months
- able to stand for 10 minutes
- Able to lift arms overhead
Key exclusion criteria (6 listed)
- Chronic Obstructive Pulmonary Disease
- acute respiratory distress
- supplemental oxygen use
- inability to stand, flex trunk, or move arms overhead
- Pacemaker implant
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 |
|---|---|---|
| Deep breathing with Yoga positioningAlso: Novel breathing and mindfulness moving-meditation.Deep breathing with yoga positioning 10min in morning, 1 minute noon, and 1 minute evening (diner) | Other | Deep breathing with Yoga positioning |
Primary outcome
Change rom baseline in body Weight
Time frame: Baseline, 10 days, 30 days, and 60 days.
Weight in kilograms
Change from baseline in Body Mass Index
Time frame: Baseline, 10 days, 30 days, and 60 days.
DEXA Measurement of % total fat
4 secondary outcomes
Human Growth Hormone - Metabolic rate
Time frame: baseline, 10 days, 30 days, 60 days
VO2 at rest, Oxygen consumption at rest-resting metabolic rate(RMR)
Time frame: Baseline, 10 days, 30 days, and 60 days.
Respiratory quotient (RQ) - metabolic rate
Time frame: Baseline, 10 days, 30 days, and 60 days.
lipid panel - metabolic rate
Time frame: Baseline, 10 days, 30 days, and 60 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Results publication: PubMed 21551954Sato K, Kawamura T, Yamagiwa S. The "Senobi" breathing exercise ameliorates depression in obese women through up-regulation of sympathetic nerve activity and hormone secretion. Biomed Res. 2011 Apr;32(2):175-80. doi: 10.2220/biomedres.32.175.
- Results publication: PubMed 20834183Sato K, Kawamura T, Yamagiwa S. The "Senobi" breathing exercise is recommended as first line treatment for obesity. Biomed Res. 2010 Aug;31(4):259-62. doi: 10.2220/biomedres.31.259.
- Results publication: PubMed 20930645Sato K, Kawamura T, Abo T. "Senobi" stretch ameliorates asthma symptoms by restoring autonomic nervous system balance. J Investig Med. 2010 Dec;58(8):968-70. doi: 10.231/JIM.0b013e3181f9167b.
- Results publication: PubMed 34188389Nivethitha L, Mooventhan A, Manjunath NK. Evaluation of Cardiovascular Functions during the Practice of Different Types of Yogic Breathing Techniques. Int J Yoga. 2021 May-Aug;14(2):158-162. doi: 10.4103/ijoy.IJOY_61_20. Epub 2021 May 10.
- Results publication: PubMed 29188396Nivethitha L, Mooventhan A, Manjunath NK, Bathala L, Sharma VK. Cerebrovascular Hemodynamics During the Practice of Bhramari Pranayama, Kapalbhati and Bahir-Kumbhaka: An Exploratory Study. Appl Psychophysiol Biofeedback. 2018 Mar;43(1):87-92. doi: 10.1007/s10484-017-9387-8.
- Individual participant dataSharing planned: No. To protect privacy of subjects, Data will be reported as cumulative without individual participant data. In the event of potential health adverse disease process IPD may be shared with individuals' consent to their designated, licensed, healthcare provider.
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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.
Michael S Laymon, DSc, PT principal investigator
Touro University Nevada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep breathing with Yoga positioning in people with Weight Loss and Metabolism, run by Touro University Nevada 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Oct 2022. 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?
Results are not available in the source record.
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 rom baseline in body Weight (time frame: Baseline, 10 days, 30 days, and 60 days.). 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 NCT05488574, which also lists 5 linked publications.
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 24 Oct 2022.