HealthyNCT06147557
Effect of Passive Heat Therapy on Metabolism
A study testing Heat therapy in people with Healthy, run by Lithuanian Sports University at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Heat therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Oct 2020to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- smokers;
- obesity (BMI greater than 30 kg/m2);
- needle phobia;
- taking medication and/or dietary supplements that may affect experimental variables.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?"
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- Heat therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat therapyProcedure or surgery
14 heat sessions, during each session subjects were fully immersed in a 45°C water bath for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Heat therapy | Experimental | 14 heat sessions of whole-body immersed in a 45°C water bath for 5 minutes. Receives: Procedure: Heat therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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,
Measured: 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
Measured: 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.
Measured: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Secondary outcomes (7)
Change in body mass (kg)
Body mass (in kg) was evaluated using Tanita Body Composition Analyzer.
Measured: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in fat mass (kg)
Fat mass (in kg) was evaluated using Tanita Body Composition Analyzer.
Measured: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in fat mass (%)
Fat mass (in %) was evaluated using Tanita Body Composition Analyzer
Measured: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in fat free mass (kg)
Fat free mass (in kg) was evaluated using Tanita Body Composition Analyzer
Measured: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in fat free mass (%)
Fat free mass (in %) was evaluated using Tanita Body Composition Analyzer
Measured: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in body mass index (kg/m2)
Body mass index (in kg/m2) was evaluated using Tanita Body Composition Analyzer
Measured: Pre-condition, post-condition (after 14 days), and after 1 month recovery
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.
Measured: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Oct 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marius Brazaitis, PhD, Principal investigator, Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147557
- Sponsor's protocol ID
- LithuananianSportsU-16
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Brief Passive Heat Therapy on Metabolism in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT06147557
- Acronym / sponsor ID
- LithuananianSportsU-16
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?"
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heat therapy | Experimental | Procedure: Heat therapy14 heat sessions of whole-body immersed in a 45°C water bath for 5 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- smokers;
- obesity (BMI greater than 30 kg/m2);
- needle phobia;
- taking medication and/or dietary supplements that may affect experimental variables.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat therapy14 heat sessions, during each session subjects were fully immersed in a 45°C water bath for 5 minutes. | Procedure or surgery | Heat therapy |
Primary outcome
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
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
Change in glucose concentration (mmol/L)
Time frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
The venous glucose concentration (in mmol/L) was measured using a Glucocard X-mini plus meter.
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).
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.
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.
Change in fat oxidation (g/min
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 fat oxidation (FATox; g/min) was calculated by using the equation: FATox = 1.67 × VO2 - 1.67 × VCO2,
Change in fat oxidation (g/min)
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 carbohydrate oxidation (CARBox; g/min) was calculated by using the equation: CARBox = 4.55 × VCO2 - 3.21 × VO2
Change in resting energy expenditure (kcal/day)
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 resting energy expenditure (REE; kcal/day) was calculated by using the Weir equation: REE = (3.941(VO2) + 1.106(VCO2)) × 1440.
7 secondary outcomes
Change in body mass (kg)
Time frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in fat mass (kg)
Time frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in fat mass (%)
Time frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in fat free mass (kg)
Time frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in fat free mass (%)
Time frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in body mass index (kg/m2)
Time frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Change in oxygen consumption and carbon dioxide output (mL/min)
Time frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius Brazaitis, PhD principal investigator
Lithuanian Sports University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat therapy in people with Healthy, run by Lithuanian Sports University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in catecholamines concentration (ng/mL) (time frame: Pre-condition, post-condition (after 14 days), and after 1 month recovery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.