Body Temperature ChangesPrep4heatNCT06389604
Preparing for Heat Waves - Enhancing Human Thermophysiological Resilience
A study testing Heat acclimation in people with Body Temperature Changes and Heat Exposure, run by Maastricht University Medical Center.
Trial summary
As the ongoing progression of climate change exposes individuals to elevated temperatures and an escalating frequency of extreme heat events, the risk of more intense and prolonged heat waves raises significant concerns for public health, particularly among vulnerable populations. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Changes, Heat Exposure, Heat Stress
- What is being tested?
- Heat acclimation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Dec 2024
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females
- 60 to 80 years
- BMI 25-30 kg/m2
- Sedentary (<2h exercise/week)
Who cannot join
- Presence of chronic cardiovascular disease, as determined by medical history and physical examination
- Participating in a structured exercise program
- Taking hot baths/saunas regularly
- Travelled for a prolonged time to destinations with elevated temperatures the last 3 months
- Pre-existing T2DM
- Blood donation within a month of study initiation
Show all 10Show fewer
- People with low haemoglobin concentration (males: Hb = 13.5-17.5 g/dL, females: Hb = 11.5-15.5 g/dL)
- Recent participation in biomedical study (less than 1 month)
- Using any medication that may influence glucose or lipid metabolism (beta-blockers, thyroid medications, stimulants, antidepressants, anticoagulants)
- Smoking or abuse of alcohol
Trial locations and contacts
No sites are listed yet.
About this study
As the ongoing progression of climate change exposes individuals to elevated temperatures and an escalating frequency of extreme heat events, the risk of more intense and prolonged heat waves raises significant concerns for public health, particularly among vulnerable populations. The physiological response to acute heat stress involves involuntary thermolytic reactions that may strain the cardiovascular system, especially in individuals with pre-existing vulnerabilities. Heat acclimation has been identified as a potential strategy to enhance thermoregulation and mitigate the adverse effects of heat stress. While existing research primarily focuses on athletes and military, this study aims to investigate the impact of a practical heat acclimation strategy, combining passive and active heat exposure, on thermophysiological, cardiovascular and metabolic parameters in healthy overweight adults. The study targets a population at increased risk for heat-related complications, seeking to provide realistic guidelines for broader application when a heat wave appears on the weather forecast.
Read the detailed description
A non-randomized, within-subject experimental trial will be conducted. The complete study will consist of a screening day, a control week, a heat acclimation week, 3 heat stress test (HST) and meal-test (MT) days (t = -7, 0, and 8 (days)). To avoid a confounding effect of seasonal thermal differences and achieve maximal methodological quality, the study will be performed in the shortest possible timeframe for each participant. Given the seasonal fluctuations in NL, transitioning from April (~7oC) to June (~20oC), a crossover design is not applicable as a washout period of approximately 2 months would be needed and the measurements would likely take place in different climatic outdoor conditions. In total, 12 healthy male and female participants will be included in the study. During the no-intervention week (week 1), participants will be asked to continue their normal life at home, without being present at the university. In addition, during week 1, participants will be asked to wear a temperature sensor on their clothing to measure the environment temperature they are exposed to at home. Thereafter, on the intervention week (week 2), participants will be exposed to increasing elevated temperatures and undergo 30 min of low-to-moderate intensity cycling in the heated laboratory room for 7 days. The temperature settings are derived from past heat waves in the Netherlands, ensuring a realistic representation. The low exercise intensity is selected to be accessible to the majority of individuals within the target population. The HST-MT will be conducted on the first visit after the screening to serve as baseline measurements. The same tests will also be repeated before and after the heat acclimation week to determine the physiological response to increasing ambient temperatures. All measurements will take place in the Metabolic Research Unit of Maastricht University (MRUM), the Netherlands.
- Conditions
- Body Temperature Changes, Heat Exposure, Heat Stress, Hyperthermia
- Being tested
- Heat acclimation
- Keywords
- heat acclimation, thermoregulation, heat exposure, cardiovascular
- Medical subject headings
- Body Temperature Changes, Heat Stress Disorders, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat acclimationOther
Daily repeated heat exposure to assess the effects of combined passive and active heat acclimation
| Study group | Role | What they receive |
|---|---|---|
| Heat acclimation | Experimental | Passive heat exposure (29-35ºC; 6h/day for 7 days) in combination with 30min/day low-to-moderate intensity cycling. Receives: Other: Heat acclimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
thermophysiological parameters (ºC)
Measured: 1 week of heat acclimation
Secondary outcomes (10)
Skin temperature
thermophysiological parameters (ºC)
Measured: 1 week of heat acclimation
Sweat rate
thermophysiological parameters (mL/min)
Measured: 1 week of heat acclimation
Heart rate
cardiovascular parameters (bpm)
Measured: 1 week of heat acclimation
Blood pressure
cardiovascular parameters (mmHg)
Measured: 1 week of heat acclimation
Skin blood flow
cardiovascular parameters (mL/min)
Measured: 1 week of heat acclimation
Energy expenditure
Metabolic parameters (kJ/min)
Measured: 1 week of heat acclimation
Substrate oxidation
glucose and fat oxidation (umol/kg/min)
Measured: 1 week of heat acclimation
Plasma metabolites
Plasma glucose, insulin, free-fatty acids, triglycerides, total cholesterol (mmol/L)
Measured: 1 week of heat acclimation
Brain blood flow
additional cardiovascular parameters (mL/min)
Measured: 1 week of heat acclimation
Flow-mediated dilation
endothelial function, (mm)
Measured: 1 week of heat acclimation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body Temperature ChangesStudies 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
- Model description
- Non-randomized, within subject experiemental trial
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannah Pallubinsky, Dr., Principal investigator, Maastricht UniversityGuy Plasqui, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389604
- Sponsor's protocol ID
- NL86367.068.24
- Acronym
- Prep4heat
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pallubinsky H, Schellen L, Kingma BRM, Dautzenberg B, van Baak MA, van Marken Lichtenbelt WD. Thermophysiological adaptations to passive mild heat acclimation. Temperature (Austin). 2017 Mar 10;4(2):176-186. doi: 10.1080/23328940.2017.1303562. eCollection 2017.
PubMed 28680933Pallubinsky H, Phielix E, Dautzenberg B, Schaart G, Connell NJ, de Wit-Verheggen V, Havekes B, van Baak MA, Schrauwen P, van Marken Lichtenbelt WD. Passive exposure to heat improves glucose metabolism in overweight humans. Acta Physiol (Oxf). 2020 Aug;229(4):e13488. doi: 10.1111/apha.13488. Epub 2020 Jun 1.
PubMed 32359193
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing for Heat Waves - Enhancing Human Thermophysiological Resilience
- ClinicalTrials.gov ID
- NCT06389604
- Acronym / sponsor ID
- Prep4heat / NL86367.068.24
- Conditions
- Body Temperature Changes, Heat Exposure, Heat Stress, Hyperthermia
- Keywords
- heat acclimation, thermoregulation, heat exposure, cardiovascular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Apr 2024 (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.
As the ongoing progression of climate change exposes individuals to elevated temperatures and an escalating frequency of extreme heat events, the risk of more intense and prolonged heat waves raises significant concerns for public health, particularly among vulnerable populations. The physiological response to acute heat stress involves involuntary thermolytic reactions that may strain the cardiovascular system, especially in individuals with pre-existing vulnerabilities. Heat acclimation has been identified as a potential strategy to enhance thermoregulation and mitigate the adverse effects of heat stress. While existing research primarily focuses on athletes and military, this study aims to investigate the impact of a practical heat acclimation strategy, combining passive and active heat exposure, on thermophysiological, cardiovascular and metabolic parameters in healthy overweight adults. The study targets a population at increased risk for heat-related complications, seeking to provide realistic guidelines for broader application when a heat wave appears on the weather forecast.
Detailed description
A non-randomized, within-subject experimental trial will be conducted. The complete study will consist of a screening day, a control week, a heat acclimation week, 3 heat stress test (HST) and meal-test (MT) days (t = -7, 0, and 8 (days)). To avoid a confounding effect of seasonal thermal differences and achieve maximal methodological quality, the study will be performed in the shortest possible timeframe for each participant. Given the seasonal fluctuations in NL, transitioning from April (~7oC) to June (~20oC), a crossover design is not applicable as a washout period of approximately 2 months would be needed and the measurements would likely take place in different climatic outdoor conditions. In total, 12 healthy male and female participants will be included in the study. During the no-intervention week (week 1), participants will be asked to continue their normal life at home, without being present at the university. In addition, during week 1, participants will be asked to wear a temperature sensor on their clothing to measure the environment temperature they are exposed to at home. Thereafter, on the intervention week (week 2), participants will be exposed to increasing elevated temperatures and undergo 30 min of low-to-moderate intensity cycling in the heated laboratory room for 7 days. The temperature settings are derived from past heat waves in the Netherlands, ensuring a realistic representation. The low exercise intensity is selected to be accessible to the majority of individuals within the target population. The HST-MT will be conducted on the first visit after the screening to serve as baseline measurements. The same tests will also be repeated before and after the heat acclimation week to determine the physiological response to increasing ambient temperatures. All measurements will take place in the Metabolic Research Unit of Maastricht University (MRUM), the Netherlands.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, within subject experiemental trial
| Arm | Type | Receives |
|---|---|---|
| Heat acclimation | Experimental | Other: Heat acclimationPassive heat exposure (29-35ºC; 6h/day for 7 days) in combination with 30min/day low-to-moderate intensity cycling. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males and females
- 60 to 80 years
- BMI 25-30 kg/m2
- Sedentary (<2h exercise/week)
Key exclusion criteria (10 listed)
- Presence of chronic cardiovascular disease, as determined by medical history and physical examination
- Participating in a structured exercise program
- Taking hot baths/saunas regularly
- Travelled for a prolonged time to destinations with elevated temperatures the last 3 months
- Pre-existing T2DM
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 acclimationDaily repeated heat exposure to assess the effects of combined passive and active heat acclimation | Other | Heat acclimation |
Primary outcome
Core temperature
Time frame: 1 week of heat acclimation
thermophysiological parameters (ºC)
10 secondary outcomes
Skin temperature
Time frame: 1 week of heat acclimation
Sweat rate
Time frame: 1 week of heat acclimation
Heart rate
Time frame: 1 week of heat acclimation
Blood pressure
Time frame: 1 week of heat acclimation
Skin blood flow
Time frame: 1 week of heat acclimation
Energy expenditure
Time frame: 1 week of heat acclimation
Substrate oxidation
Time frame: 1 week of heat acclimation
Plasma metabolites
Time frame: 1 week of heat acclimation
Brain blood flow
Time frame: 1 week of heat acclimation
Flow-mediated dilation
Time frame: 1 week of heat acclimation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Background: PubMed 28680933Pallubinsky H, Schellen L, Kingma BRM, Dautzenberg B, van Baak MA, van Marken Lichtenbelt WD. Thermophysiological adaptations to passive mild heat acclimation. Temperature (Austin). 2017 Mar 10;4(2):176-186. doi: 10.1080/23328940.2017.1303562. eCollection 2017.
- Background: PubMed 32359193Pallubinsky H, Phielix E, Dautzenberg B, Schaart G, Connell NJ, de Wit-Verheggen V, Havekes B, van Baak MA, Schrauwen P, van Marken Lichtenbelt WD. Passive exposure to heat improves glucose metabolism in overweight humans. Acta Physiol (Oxf). 2020 Aug;229(4):e13488. doi: 10.1111/apha.13488. Epub 2020 Jun 1.
- 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.
Hannah Pallubinsky, Dr. principal investigator
Maastricht University
Guy Plasqui principal investigator
Maastricht University
Questions about this trial
What is this clinical trial studying?
A study testing Heat acclimation in people with Body Temperature Changes and Heat Exposure, run by Maastricht University Medical Center.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofia Pappa, M.Sc. (+31433882507, sofia.pappa@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature (time frame: 1 week of heat acclimation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06389604, which also lists 2 linked publications.
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 29 Apr 2024.