Adaptive Stress Response: The Hot Yoga Study

Aging Clinical Trial

Official title:

Molecular Networks Involved in the Adaptive Stress Response: The Hot Yoga Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06395376
• Other study ID #: IRB1911122754
• Status: Completed
• Phase: N/A
• Start date: February 11, 2023
• Est. completion date: May 15, 2023

Study information

• Verified date: April 2024
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 15, 2023
• Est. primary completion date: May 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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

5. Agree not to take interfering medications (stated in 'Exclusion Criteria' section below) during the duration of the study

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 Exclusion Criteria:1) Menopausal 2) Answered "Yes" to any question on the Physical Activity Readiness Questionnaire (PAR-Q) 3) Currently lactating 4) Currently pregnant or plan to get pregnant within the duration of the study 5) Has participated in hot yoga within the last 12-months 6) Used tobacco products (smoked, smokeless, electronic) within the last six months 7) Have diabetes, cancer, heart attack or vascular surgery within the past year, be diagnosed with heart disease, high blood pressure, history of stroke, atherosclerosis, asthma, multiple sclerosis or chronic joint disease 8) Have gallbladder disease or had

gallbladder removed 9) Have any of the following health conditions:

• 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

Related Conditions & MeSH terms

• Aging
• Depression, Anxiety
• Inflammation

Intervention

Other:
• 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)
• 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.

Locations

Country	Name	City	State
United States	Tucson Yoga Sol	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in body wieght	Body weight in kilograms (kg) will be measured at baseline and at the end of the intervention (Week 6) to determine any changes in body weight as result of participating in the intervention.	Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Other	Changes Body Mass Index (BMI) in kg/m^2	Body Mass Index (BMI, kg/m^2) will be calculated using height measured and baseline and body weight measured at baseline and at the end of intervention (Week 6) to determine any changes in BMI as result of participating in the intervention.	Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Other	Changes in waist-to-hip ratio (WHR)	Waist circumference (cm) and hip circumference (cm) will be measured at baseline and end of intervention (Week 8). These measurements will be used to calculate waist-to-hip ratio to determine any changes in WHR as result of participating in the intervention. The ratio is without units.	Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Other	Changes in blood pressure (Systolic/Diastolic, in mmHg)	Blood pressure (mmHg) will be measured using an automated blood pressure instrument at baseline and at the end of intervention (Week 6) to determine any changes in blood pressure as result of participating in the intervention.	Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Other	Change in percent body fat (%Fat)	Body fat (%Fat) was measured using an arm-to-arm bioelectrical impedance analyzer and reported as a percent of total fat relative to total body weight.	Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Primary	Inflammatory biomarkers	cytokines and hsCRP	Assessed at baseline, Intervention week1, intervention midpoint (3 weeks), end of intervention (Week 6). end of study (Week 12; after washout)
Primary	Blood Lipids	Lipid panel (milligrams per deciliter, mg/dL)	Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Primary	Hemoglobin A1C	Comprehensive Metabolic Panel (millimole per mole, mmol/mol)	Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Primary	Fasting glucose/insulin	Comprehensive Metabolic Panel (milligrams per deciliter, mg/dL)	Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)
Primary	Immune cell phenotypes	Percent Immune phenotypes	Measured at the Start of Intervention (Week1), intervention midpoint (Week 3), end of intervention (Week 6), and end of study (Week 12; after washout)
Secondary	Positive and Negative Affect Schedule (PANAS) (Measures Positive and Negative Mood)	The Positive and Negative Affect Schedule (PANAS) questionnaire used as a self-report measure of mood and is made up of two mood scales, one measuring positive affect and the other measuring negative affect. The questionnaire consists of 20 items and uses a likert scale of "1" to "5" to measure responses of "1" (Very slightly or not at all), "2" (A little), "3" (Moderately), "4" (Quite a bit), and "5" (Extremely)	Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Secondary	PROMIS (Patient Reported Outcomes Measurement Information System) - Global Health Scale (Measures well-being)	PROMIS is a system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. This instrument uses a "reverse" Likert scale of "5" to "1" to measure responses of "5" (Excellent), "4" (Very good), "3" (Good), "2" (Fair), and "1" (Poor) to measure responses to 10 items.	Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Secondary	Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Measures well-being)	Warwick-Edinburgh Mental Well-being Scale (WEMWBS) measures subjective well-being and assesses aspects of well-being that are "conducive to happiness or eudemonic" and "sensually self-indulgent or hedonistic". This instrument has 14 items and uses a Likert scale of "1" to "5" to measure responses: "1" (None of the time), "2" (Rarely), "3" (Some of the time), "4" (Often), and "5" (All of the time)	Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Secondary	Patient Health Questionnaire (PHQ-9) (Measures depression)	Patient Health Questionnaire (PHQ-9) is a multipurpose instrument that has two questions (the first is split into 9 "subsections") and is used for screening, diagnosing, monitoring and measuring the severity of depression. A scale of "0-3" is assigned to the four boxes. These numbers represent an individual value for each item (depending on which box is checked) that, when summed, provides a "total score" that is representative of a level of depression.	Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Secondary	Generalized Anxiety Disorder (GAD-7)	Generalized Anxiety Disorder (GAD-7) consists of seven items used to measure worry and anxiety symptoms using a "0" to "3" Likert scale to score responses to "how often": "0" (Not at all sure), "1" (Several Days), "2" (Over half the days), "3" (Nearly every day).	Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)
Secondary	Perceived Stress Scale (PSS)	Perceived Stress Scale (PSS) uses ten questions to measure the degree to which situations in one's life are appraised/perceived as stressful. This instrument uses a Likert scale of "0" to "4": "0" (Never), "1" (Almost never), "2" (Sometimes), "3" (Fairly Often), "4" (Very Often).	Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)