- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05107570
The Effect of Cold Exposure on Energy Expenditure
July 26, 2022 updated by: Maastricht University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Maastricht, Netherlands, 6229 ER
- Maastricht University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent
- Western European origin or of Siberian origin
- BMI between 18.5 and 35 kg/m2
- Generally healthy (determined by dependent physician)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Cold exposure applied to Western European individuals
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.
|
Cold air exposure (~ 9°C, maximum 1 hour duration)
|
|
Other: Cold exposure applied to Siberian individuals
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.
|
Cold air exposure (~ 9°C, maximum 1 hour duration)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cold-induced thermogenesis
Time Frame: 30 min before and during the cold exposure (maximum 1 hour)
|
Energy expenditure with indirect calorimetry
|
30 min before and during the cold exposure (maximum 1 hour)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin temperature
Time Frame: 30 min before and during the cold exposure (maximum 1 hour)
|
Skin temperature determined with iButtons, measured in °C
|
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)
|
Core temperature determined with a gastrointestinal pill, measured in °C
|
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)
|
Electromyography will be used to measure the electrical activity of 3 skeletal muscles
|
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)
|
Carbohydrate and fat oxidation will be determined with indirect calorimetry
|
30 min before and during the cold exposure (maximum 1 hour)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: W. van Marken Lichtenbelt, PhD, Maastricht University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2021
Primary Completion (Actual)
May 2, 2022
Study Completion (Actual)
May 2, 2022
Study Registration Dates
First Submitted
September 21, 2021
First Submitted That Met QC Criteria
October 25, 2021
First Posted (Actual)
November 4, 2021
Study Record Updates
Last Update Posted (Actual)
July 28, 2022
Last Update Submitted That Met QC Criteria
July 26, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- WEU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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