Adaptive Stress Response: The Hot Yoga Study

NCT ID: NCT06395376

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-11
• Study Completion Date: 2023-05-15

Brief Summary

This is a small intervention study which is aimed at characterizing what is known as the adaptive stress response (also know as "hormesis") in women aged 30-45 years. Participants will perform Bikram Yoga in a room heated to 104°F (40°C) which is often referred to as "Hot Yoga".

The hypothesis of this study is that a protective and health-promoting adaptive stress response can be induced in living humans by performing exercise in a hot environment. The primary question is:How does the body physiologically adapt to performing moderately vigorous exercise in a hot environment?

Detailed Description

This is a small scale intervention pilot study which is aimed at characterizing "hormesis" or the "adaptive stress response" in a small cadre (n = 28) of women aged 30-45 years performing moderately vigorous physical activity, Bikram Yoga, in a hot environment, simply referred to as "Hot Yoga". The primary question is:How does the body physiologically adapt to performing moderately vigorous exercise in a hot environment?

The hypothesis of this study which underlies the primary question is that a protective and health-promoting adaptive stress response can be induced in living humans through exposure to mild heat stress and moderately vigorous physical exercise while practicing hot yoga. The central premise is that a combination of environmental stressors during each hot yoga session will induce changes in molecular networks and metabolism that will enhance physical/mental health and physiological resilience.

Primary, secondary and tertiary study endpoints:

Characterize the physiological changes brought on by the adaptive stress response using an "omics" approach. Lipidomics and metabolomics will be used to identify changes in small molecule species found in circulating plasma that are associated with the physiological changes the investigators anticipate will occur with the adaptive stress response.

Characterize the adaptive stress response by measuring the changes in the inflammatory response using common inflammation biomarkers: C-reactive protein (CRP), Tumor Necrosis Factor Alpha (TNF-alpha), and Interleukin-6 (IL-6). A complete blood count (CBC) w/Differential assay will also be performed at baseline and after the last Hot Yoga practice to assess any changes in blood components (red blood cells [RBC], white blood cells [WBC], platelets, etc.) that may have occurred in response to the intervention. In addition, the investigators will use buffy coat to assay all WBCs and will perform both typing and counting of WBCs to assess changes relevant to the adaptive stress response. Finally, buffy coat will be used for DNA isolation to genotype for single nucleotide polymorphisms (SNPs) that are related to the adaptive stress response.

Characterize the acute effect that exercising in a hot environment has on emotional stress and well-being using:

Positive and Negative Affect Schedule - Short Form (PANAS-SF) PROMIS - Global Health Scale

Assess long-term effects of the intervention on emotional stress and well-being using a battery of questionnaires that include Warwick-Edinburgh Mental Well-being Scale (WEMWBS) Patient Health Questionnaire (PHQ-9) Generalized Anxiety Disorder (GAD-7) Perceived Stress Scale (PSS)

Importantly, circulating levels of small molecule metabolites will be determined with metabolomic and lipidomic analyses utilizing HPLC-tandem mass spectrometry. Levels of blood inflammatory and stress biomarkers interleukin-6 (IL-6), Tumor Necrosis Factor Alpha (TNF-α), and C-reactive protein (CRP) will be measured utilizing standard enzyme linked immunosorbent assays (ELISA). These assays may be performed in-house or at Sonora Quest Laboratories.

The investigators will implement the use of biostatistics, bioinformatics, and other statistical methods to analyze, interpret, and express the found data and dependent upon the findings, then use the data as the base for grant funding to conduct a full scale clinical trial testing the aforementioned hypotheses.

Conditions

Inflammation; Aging; Depression, Anxiety

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hot Yoga Intervention

Bikram Hot Yoga intervention: Participants perform a minimum of 60-minutes of Hot Yoga (Bikram Sequence), 3x per week in a heated room (40 degrees C) for 6-weeks

Group Type: EXPERIMENTAL

Bikram Hot Yoga Intervention

Intervention Type: OTHER

Active participants engage in a yoga intervention which entails participating in a minimum of 60-minutes of hot yoga (Bikram sequence), 3x per week in a heated room at 40 degrees C. The intervention will be 6-weeks of active intervention when they are participating in yoga, followed by an 6-week "washout" period where they will be asked to not practice yoga. Participants will be asked to give blood at 9 timepoints throughout the 12-week study, including baseline, week one, midpoint, end of Hot Yoga Intervention (Week 6) and after Washout (Week 12)

Hot Yoga Washout

Hot Yoga Washout: Participants complete a 6-week "Washout" period during which the participants performed no Hot Yoga.

Group Type: OTHER

Hot Yoga Washout

Intervention Type: OTHER

The "Washout" period consists of 6-weeks occurring immediately after the Hot Yoga Intervention during which the participants do not perform any hot yoga.

Interventions

Bikram Hot Yoga Intervention

Active participants engage in a yoga intervention which entails participating in a minimum of 60-minutes of hot yoga (Bikram sequence), 3x per week in a heated room at 40 degrees C. The intervention will be 6-weeks of active intervention when they are participating in yoga, followed by an 6-week "washout" period where they will be asked to not practice yoga. Participants will be asked to give blood at 9 timepoints throughout the 12-week study, including baseline, week one, midpoint, end of Hot Yoga Intervention (Week 6) and after Washout (Week 12)

Intervention Type: OTHER

Hot Yoga Washout

The "Washout" period consists of 6-weeks occurring immediately after the Hot Yoga Intervention during which the participants do not perform any hot yoga.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy, non-menopausal women between the aged 30 to 45 years (≥30 years and ≤45 years)

2. Not pregnant/not planning to get pregnant during the study duration

3. Have not previously participated in hot yoga in the last 12-months

4. Able to give informed consent and be willing to participate for the entirety of the study

Exclusion Criteria

6. Agree to allow samples to be stored for future use

7. Pass the preliminary health screening

8. Answer no for every question on the Physical Activity Readiness Questionnaire (PAR-Q ) during preliminary screening

• fasting Triglycerides greater than 150 milligrams/deciliter
• Blood pressure greater than 130/90
• Body Mass Index equal to or greater than 30 or less than 19
• Fasting glucose greater than 125 milligrams/deciliter.
• Having a pacemaker or a defibrillator 10) Taking any of the following drugs:
• Taking greater than 100 mg aspirin/day
• Taking non-steroidal anti-inflammatory drugs or oral corticosteroids
• Taking monteleukast-type of allergy medications
• Use of statins, niacin or fibrates or other lipid lowering medications

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Floyd Chilton

Professor, Department of Nutritional Sciences Director, Precision Nutrition & Wellness Initiative Associate Director,The BIO5 Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Floyd Chilton, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

Tucson Yoga Sol

Tucson, Arizona, United States

Countries

United States

Other Identifiers

IRB1911122754

Identifier Type: -

Identifier Source: org_study_id