Effects of Novel Breathing Behavior Modification Yoga Positioning Integrated Program on Weight Loss

Weight Loss Clinical Trial

— Breathing  

Official title:

Effects of Novel Breathing, Behavior Modification, Yoga Positioning Integrated Program on Weight Loss.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05488574
• Other study ID #: ML-CHHS-22-338
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: November 23, 2022

Study information

• Verified date: October 2022
• Source: Touro University Nevada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: November 23, 2022
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Metabolism
• Weight Loss

Intervention

Other:
• Deep breathing with Yoga positioning
Deep breathing with yoga positioning 10min in morning, 1 minute noon, and 1 minute evening (diner)

Locations

Country	Name	City	State
United States	Michael Laymon	Henderson	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Touro University Nevada

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	stress level - autonomic function	Heart Rate Variability	Baseline, 10 days, 30 days, 60 days
Other	Depression	Hamilton Depression Rating Scale (HAM-D) depression index self reported survey scored 0-62 with higher score indicating a worse outcome.	Baseline, 10 days, 30 days, and 60 days.
Other	Sleep	Insomnia Severity Index (ISI) self reported survey scored 0-28 with higher score indicating worse outcome.	Baseline, 10 days, 30 days, and 60 days.
Primary	Change rom baseline in body Weight	Weight in kilograms	Baseline, 10 days, 30 days, and 60 days.
Primary	Change from baseline in Body Mass Index	DEXA Measurement of % total fat	Baseline, 10 days, 30 days, and 60 days.
Secondary	Human Growth Hormone - Metabolic rate	Measurement of Human Growth Hormone	baseline, 10 days, 30 days, 60 days
Secondary	VO2 at rest, Oxygen consumption at rest-resting metabolic rate(RMR)	Oxygen consumption via oxygen plethysmograph	Baseline, 10 days, 30 days, and 60 days.
Secondary	Respiratory quotient (RQ) - metabolic rate	CO2 eliminated/O2 consumed	Baseline, 10 days, 30 days, and 60 days.
Secondary	lipid panel - metabolic rate	Total cholesterol, high density lipids, low density lipids, triglycerides	Baseline, 10 days, 30 days, and 60 days.