Clinical trial NCT05488574: Effects of Novel Breathing Behavior Modification Yoga Positioning Integrated Program on Weight Loss
Official title: Effects of Novel Breathing, Behavior Modification, Yoga Positioning Integrated Program on Weight Loss.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Metabolism
Keywords: metabolism
obesity
mentation
Lead sponsor: Touro University Nevada
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized control group, investigator blinded, repeated measure interventional program.
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change rom baseline in body Weight
timeFrame: Baseline, 10 days, 30 days, and 60 days.
measure: Change from baseline in Body Mass Index
timeFrame: Baseline, 10 days, 30 days, and 60 days.
Secondary outcomes:
measure: Human Growth Hormone - Metabolic rate
timeFrame: baseline, 10 days, 30 days, 60 days
measure: VO2 at rest, Oxygen consumption at rest-resting metabolic rate(RMR)
timeFrame: Baseline, 10 days, 30 days, and 60 days.
measure: Respiratory quotient (RQ) - metabolic rate
timeFrame: Baseline, 10 days, 30 days, and 60 days.
measure: lipid panel - metabolic rate
timeFrame: Baseline, 10 days, 30 days, and 60 days.
Other outcomes:
measure: stress level - autonomic function
timeFrame: Baseline, 10 days, 30 days, 60 days
measure: Depression
timeFrame: Baseline, 10 days, 30 days, and 60 days.
measure: Sleep
timeFrame: Baseline, 10 days, 30 days, and 60 days.
Locations:
city: Henderson
country: United States
facility: Michael Laymon
state: Nevada
Study officials:
affiliation: Touro University Nevada
name: Michael S Laymon, DSc, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sato 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.
citation: Sato 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.
citation: Nivethitha 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.
citation: Nivethitha 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.