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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06147557
Other study ID # LithuananianSportsU-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date May 31, 2022

Study information

Verified date November 2023
Source Lithuanian Sports University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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?"


Description:

No studies yet addressed whether brief heat stimuli could be viable time-efficient alternative approach in order to improve glucose metabolism and fat oxidation. Consequently, we aimed to examine the ability of brief noxious heat stimuli to improve glucose tolerance, insulin sensitivity, and fat oxidation in young adults. Non-obese males and females completed fourteen 5-min sessions involving whole body passive heating at 45°C water. Changes in catecholamines, cytokines, substrate oxidation, resting energy expenditure, glucose tolerance and insulin response were assessed.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Heat therapy
14 heat sessions, during each session subjects were fully immersed in a 45°C water bath for 5 minutes.

Locations

Country Name City State
Lithuania Institute of Sport Science and Innovations Kaunas

Sponsors (1)

Lead Sponsor Collaborator
Lithuanian Sports University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in catecholamines concentration (ng/mL) The venous plasma adrenaline and noradrenaline concentrations (in ng/mL) were measured using enzyme-linked immunosorbent assay kits and a Spark multimode microplate reader Pre-condition, post-condition (after 14 days), and after 1 month recovery
Primary Changes in cytokines concentration (pg/mL) 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 Pre-condition, post-condition (after 14 days), and after 1 month recovery
Primary Change in glucose concentration (mmol/L) The venous glucose concentration (in mmol/L) was measured using a Glucocard X-mini plus meter. Pre-condition, post-condition (after 14 days), and after 1 month recovery
Primary Change in insulin concentration (µIU/mL) 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
Primary Change in insulin sensitivity 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. Pre-condition, post-condition (after 14 days), and after 1 month recovery
Primary Change in substrate oxidation 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. Pre-condition, post-condition (after 14 days), and after 1 month recovery
Primary Change in fat oxidation (g/min 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, Pre-condition, post-condition (after 14 days), and after 1 month recovery
Primary Change in fat oxidation (g/min) 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 Pre-condition, post-condition (after 14 days), and after 1 month recovery
Primary Change in resting energy expenditure (kcal/day) 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. Pre-condition, post-condition (after 14 days), and after 1 month recovery
Secondary Change in body mass (kg) Body mass (in kg) was evaluated using Tanita Body Composition Analyzer. Pre-condition, post-condition (after 14 days), and after 1 month recovery
Secondary Change in fat mass (kg) Fat mass (in kg) was evaluated using Tanita Body Composition Analyzer. Pre-condition, post-condition (after 14 days), and after 1 month recovery
Secondary Change in fat mass (%) Fat mass (in %) was evaluated using Tanita Body Composition Analyzer Pre-condition, post-condition (after 14 days), and after 1 month recovery
Secondary Change in fat free mass (kg) Fat free mass (in kg) was evaluated using Tanita Body Composition Analyzer Pre-condition, post-condition (after 14 days), and after 1 month recovery
Secondary Change in fat free mass (%) Fat free mass (in %) was evaluated using Tanita Body Composition Analyzer Pre-condition, post-condition (after 14 days), and after 1 month recovery
Secondary Change in body mass index (kg/m2) Body mass index (in kg/m2) was evaluated using Tanita Body Composition Analyzer Pre-condition, post-condition (after 14 days), and after 1 month recovery
Secondary Change in oxygen consumption and carbon dioxide output (mL/min) 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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