Cold ExposureNCT05107570
The Effect of Cold Exposure on Energy Expenditure
A study testing Cold exposure in people with Cold Exposure, run by Maastricht University at 1 site in Netherlands.
Trial summary
Cold-induced thermogenesis, or the increase in energy expenditure upon cold exposure, indicates metabolic stress, as such, cold-induced thermogenesis may signal an appropriate stimulus to improve metabolic health. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold Exposure
- What is being tested?
- Cold exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 May 2021to 2 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Western European origin or of Siberian origin
- BMI between 18.5 and 35 kg/m2
- Generally healthy (determined by dependent physician)
Who cannot join
- Smoking
- Active, uncontrolled cardiovascular disease or cancer
- Raynaud's disease
- Participation in another biomedical study within 1 month before the first study
- Cold-acclimated (Western European group), such as takes daily extended cold baths, works in a refrigerated environment, or regular cold-water swimming within 1 month of starting the study
- Medication use known to hamper subject's safety during study procedures
- Abuse of alcohol or drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cold-induced Thermogenesis in Adults From Siberia and Western Europe
Cold-induced thermogenesis, or the increase in energy expenditure upon cold exposure, indicates metabolic stress, as such, cold-induced thermogenesis may signal an appropriate stimulus to improve metabolic health. Cold acclimation may alter cold-induced thermogenesis due to changes in (non)shivering thermogenesis and blood flow. The main aim of this research is to compare the energy expenditure responses, during a standardised cold stress (~ 9°C air temperature, maximum 1 hour), of Siberian adults with Western European adults. The subjects will be individually matched for age, sex, body mass and height. It was hypothesised that cold-induced thermogenesis will be reduced in the Siberian population.
- Conditions
- Cold Exposure
- Being tested
- Cold exposure
- Keywords
- Cold exposure, Energy expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold exposureOther
Cold air exposure (~ 9°C, maximum 1 hour duration)
| Study group | Role | What they receive |
|---|---|---|
| Cold exposure applied to Western European individuals | Other | Participants rested under thermoneutral conditions for 30 min, which was then followed by exposure to ~ 9°C air temperature for a maximum of 1 hour. Same duration as matched Siberian individuals. Receives: Other: Cold exposure |
| Cold exposure applied to Siberian individuals | Other | Participants rested under thermoneutral conditions for 30 min, which was then followed by exposure to ~ 9°C air temperature for a maximum of 1 hour. Same duration as matched European individuals. Receives: Other: Cold exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold-induced thermogenesis
Energy expenditure with indirect calorimetry
Measured: 30 min before and during the cold exposure (maximum 1 hour)
Secondary outcomes (4)
Skin temperature
Skin temperature determined with iButtons, measured in °C
Measured: 30 min before and during the cold exposure (maximum 1 hour)
Core temperature
Core temperature determined with a gastrointestinal pill, measured in °C
Measured: 30 min before and during the cold exposure (maximum 1 hour)
Shivering activity
Electromyography will be used to measure the electrical activity of 3 skeletal muscles
Measured: 30 min before and during the cold exposure (maximum 1 hour)
Substrate oxidation
Carbohydrate and fat oxidation will be determined with indirect calorimetry
Measured: 30 min before and during the cold exposure (maximum 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start17 May 2021
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold ExposureStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- W. van Marken Lichtenbelt, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107570
- Sponsor's protocol ID
- WEU
- Status last verified
- Jul 2022
- First submitted
- 21 Sep 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold-induced Thermogenesis in Adults From Siberia and Western Europe
- ClinicalTrials.gov ID
- NCT05107570
- Acronym / sponsor ID
- WEU
- Conditions
- Cold Exposure
- Keywords
- Cold exposure, Energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 4 Nov 2021 (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.
Cold-induced thermogenesis, or the increase in energy expenditure upon cold exposure, indicates metabolic stress, as such, cold-induced thermogenesis may signal an appropriate stimulus to improve metabolic health. Cold acclimation may alter cold-induced thermogenesis due to changes in (non)shivering thermogenesis and blood flow. The main aim of this research is to compare the energy expenditure responses, during a standardised cold stress (~ 9°C air temperature, maximum 1 hour), of Siberian adults with Western European adults. The subjects will be individually matched for age, sex, body mass and height. It was hypothesised that cold-induced thermogenesis will be reduced in the Siberian population.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold exposure applied to Western European individuals | Other | Other: Cold exposureParticipants rested under thermoneutral conditions for 30 min, which was then followed by exposure to ~ 9°C air temperature for a maximum of 1 hour. Same duration as matched Siberian individuals. |
| Cold exposure applied to Siberian individuals | Other | Other: Cold exposureParticipants rested under thermoneutral conditions for 30 min, which was then followed by exposure to ~ 9°C air temperature for a maximum of 1 hour. Same duration as matched European individuals. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Western European origin or of Siberian origin
- BMI between 18.5 and 35 kg/m2
- Generally healthy (determined by dependent physician)
Key exclusion criteria (7 listed)
- Smoking
- Active, uncontrolled cardiovascular disease or cancer
- Raynaud's disease
- Participation in another biomedical study within 1 month before the first study
- Cold-acclimated (Western European group), such as takes daily extended cold baths, works in a refrigerated environment, or regular cold-water swimming within 1 month of starting the study
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 |
|---|---|---|
| Cold exposureCold air exposure (~ 9°C, maximum 1 hour duration) | Other | Cold exposure applied to Siberian individuals, Cold exposure applied to Western European individuals |
Primary outcome
Cold-induced thermogenesis
Time frame: 30 min before and during the cold exposure (maximum 1 hour)
Energy expenditure with indirect calorimetry
4 secondary outcomes
Skin temperature
Time frame: 30 min before and during the cold exposure (maximum 1 hour)
Core temperature
Time frame: 30 min before and during the cold exposure (maximum 1 hour)
Shivering activity
Time frame: 30 min before and during the cold exposure (maximum 1 hour)
Substrate oxidation
Time frame: 30 min before and during the cold exposure (maximum 1 hour)
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 28 Jul 2022.
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A Prospective Study of Cold Exposure in Patients With MASH
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Thermogenic Silencer Regulatory Factors in Humans
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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.
W. van Marken Lichtenbelt, PhD principal investigator
Maastricht 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 Cold exposure in people with Cold Exposure, run by Maastricht University at 1 site in Netherlands.
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 7 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 28 Jul 2022. 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 Netherlands. 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?
Cold-induced thermogenesis (time frame: 30 min before and during the cold exposure (maximum 1 hour)). 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 28 Jul 2022.