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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05488574
Other study ID # ML-CHHS-22-338
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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