Adaptive Stress Response: The Hot Yoga Study

NCT06395376 | Completed

• 1 other identifier: IRB1911122754
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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?

Conditions

Inflammation; Aging; Depression, Anxiety

Keywords

Yoga; Hyperthermia; Inflammation; Exercise

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (6)

• Positive and Negative Affect Schedule (PANAS) (Measures Positive and Negative Mood)

  Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)

• PROMIS (Patient Reported Outcomes Measurement Information System) - Global Health Scale (Measures well-being)

  Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)

• Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Measures well-being)

  Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)

• Patient Health Questionnaire (PHQ-9) (Measures depression)

  Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)

• Generalized Anxiety Disorder (GAD-7)

  Assessed at Baseline, Midpoint of Intervention (Week 3), End of Intervention (Week 6) and End of Study (Week 12)

Other Outcomes (5)

• Changes in body wieght

  Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)

• Changes Body Mass Index (BMI) in kg/m^2

  Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)

• Changes in waist-to-hip ratio (WHR)

  Measured at Baseline, end of intervention (Week 6), and end of study (Week 12; after washout)

Study Arms (2)

Hot Yoga Intervention

EXPERIMENTAL

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

Other: Bikram Hot Yoga Intervention

Hot Yoga Washout

OTHER

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

Other: Hot Yoga Washout

Interventions

Bikram Hot Yoga Intervention 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 Intervention

Hot Yoga Washout 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.

Hot Yoga Washout

Eligibility Criteria

• Age: 30 Years - 45 Years
• Gender Eligibility Details: Prospective participants need to be healthy women aged 30 and 45 years (≥30 years and ≤45 years). Not pregnant or planning to get pregnant, not lactating, not menopausal.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non-menopausal women between the aged 30 to 45 years (≥30 years and ≤45 years)
• Not pregnant/not planning to get pregnant during the study duration
• Have not previously participated in hot yoga in the last 12-months
• Able to give informed consent and be willing to participate for the entirety of the study

You may not qualify if:

• Agree to allow samples to be stored for future use
• Pass the preliminary health screening
• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Tucson Yoga Sol

Tucson, Arizona, 85704, United States

Location

MeSH Terms

Conditions

Inflammation; Depression; Anxiety Disorders; Hyperthermia; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Floyd Chilton, Ph.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Nutritional Sciences Director, Precision Nutrition & Wellness Initiative Associate Director,The BIO5 Institute

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 2, 2024
• Study Start: February 11, 2023
• Primary Completion: May 13, 2023
• Study Completion: May 15, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)