NCT06147557

Brief 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?"

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

November 15, 2023

Last Update Submit

November 17, 2023

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (7)

  • Change in body mass (kg)

    Pre-condition, post-condition (after 14 days), and after 1 month recovery

  • Change in fat mass (kg)

    Pre-condition, post-condition (after 14 days), and after 1 month recovery

  • Change in fat mass (%)

    Pre-condition, post-condition (after 14 days), and after 1 month recovery

  • Change in fat free mass (kg)

    Pre-condition, post-condition (after 14 days), and after 1 month recovery

  • Change in fat free mass (%)

    Pre-condition, post-condition (after 14 days), and after 1 month recovery

  • +2 more secondary outcomes

Study Arms (1)

Heat therapy

EXPERIMENTAL

14 heat sessions of whole-body immersed in a 45°C water bath for 5 minutes.

Procedure: Heat therapy

Interventions

Heat therapyPROCEDURE

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

Heat therapy

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • smokers;
  • obesity (BMI greater than 30 kg/m2);
  • needle phobia;
  • taking medication and/or dietary supplements that may affect experimental variables.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sport Science and Innovations

Kaunas, Lithuania

Location

MeSH Terms

Interventions

Diathermy

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • Marius Brazaitis, PhD

    Lithuanian Sports University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 27, 2023

Study Start

October 1, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations