- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06147557
Effect of Passive Heat Therapy on Metabolism
Effect of Repeated Brief Passive Heat Therapy on Metabolism in Healthy Young Adults
The goal of this prospective interventional study is to examine if repeated brief hot stimuli affects glucose metabolism and substrate oxidation in young non-obese adults. Young adult participants were asked to participate in fourteen 5-min procedures involving whole body passive heating at 45°C water.
The main question it aims to answer is: "Does repeated brief noxious heat stimuli is sufficient to improve glucose tolerance, insulin sensitivity, and fat oxidation in young non-obese adults?"
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaunas, Lithuania
- Institute of Sport Science and Innovations
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy non-obese (BMI between 18.5 and 29.9 kg/m2) males and females;
- no diseases, or conditions that could be worsened by exposure to acute hot water and affect experimental variables;
- no participation in any excessive formal physical exercise or sports program, temperature manipulation program or exposure to extreme temperatures.
Exclusion Criteria:
- smokers;
- obesity (BMI greater than 30 kg/m2);
- needle phobia;
- taking medication and/or dietary supplements that may affect experimental variables.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Heat therapy
14 heat sessions of whole-body immersed in a 45°C water bath for 5 minutes.
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14 heat sessions, during each session subjects were fully immersed in a 45°C water bath for 5 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in catecholamines concentration (ng/mL)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
The venous plasma adrenaline and noradrenaline concentrations (in ng/mL) were measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
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Changes in cytokines concentration (pg/mL)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
The venous serum interleukin-6 and tumor necrosis factor alpha concentrations (in pg/mL) were measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
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Change in glucose concentration (mmol/L)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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The venous glucose concentration (in mmol/L) was measured using a Glucocard X-mini plus meter.
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
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Change in insulin concentration (μIU/mL)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
The venous serum insulin concentrations (in μIU/mL) were measured using enzyme-linked immunosorbent assay kits (Cat.
No. E-EL-H2237, Elabscience, China) and a Spark multimode microplate reader (Tecan, Austria).
|
Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
|
Change in insulin sensitivity
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
Indices for insulin sensitivity/resistance assessment were computed using the homeostatic model assessment for insulin resistance, quantitative insulin-sensitivity check index (QUICKI), and the Matsuda insulin sensitivity index were calculated.
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
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Change in substrate oxidation
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
Oxygen consumption (VO2) and carbon dioxide (VCO2) output on a breath-by breath basis using a stationary MetaLyzer® 3B spiroergometry system (Cortex Biophysik GmbH) was measured at rest, and the respiratory quotient (RQ=VCO2/VO2) was computed to determine substrate utilisation.
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
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Change in fat oxidation (g/min
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Oxygen consumption (VO2) and carbon dioxide (VCO2) output on a breath-by breath basis using a stationary MetaLyzer® 3B spiroergometry system (Cortex Biophysik GmbH) was measured at rest, and the fat oxidation (FATox; g/min) was calculated by using the equation: FATox = 1.67 × VO2 - 1.67 × VCO2,
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Change in fat oxidation (g/min)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Oxygen consumption (VO2) and carbon dioxide (VCO2) output on a breath-by breath basis using a stationary MetaLyzer® 3B spiroergometry system (Cortex Biophysik GmbH) was measured at rest, and the carbohydrate oxidation (CARBox; g/min) was calculated by using the equation: CARBox = 4.55 × VCO2 - 3.21 × VO2
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Change in resting energy expenditure (kcal/day)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Oxygen consumption (VO2) and carbon dioxide (VCO2) output on a breath-by breath basis using a stationary MetaLyzer® 3B spiroergometry system (Cortex Biophysik GmbH) was measured at rest, and the resting energy expenditure (REE; kcal/day) was calculated by using the Weir equation: REE = (3.941(VO2)
+ 1.106(VCO2)) × 1440.
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in body mass (kg)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Body mass (in kg) was evaluated using Tanita Body Composition Analyzer.
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
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Change in fat mass (kg)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Fat mass (in kg) was evaluated using Tanita Body Composition Analyzer.
|
Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
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Change in fat mass (%)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Fat mass (in %) was evaluated using Tanita Body Composition Analyzer
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Change in fat free mass (kg)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Fat free mass (in kg) was evaluated using Tanita Body Composition Analyzer
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Change in fat free mass (%)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Fat free mass (in %) was evaluated using Tanita Body Composition Analyzer
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Change in body mass index (kg/m2)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Body mass index (in kg/m2) was evaluated using Tanita Body Composition Analyzer
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Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
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Change in oxygen consumption and carbon dioxide output (mL/min)
Time Frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
|
Oxygen consumption and carbon dioxide output (in mL/min) on a breath-by breath basis using a stationary MetaLyzer® 3B spiroergometry system (Cortex Biophysik GmbH) was measured at rest.
|
Pre-condition, post-condition (after 14 days), and after 1 month recovery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marius Brazaitis, PhD, Lithuanian Sports University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LithuananianSportsU-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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