The Effect of Cold Exposure on Energy Expenditure
Cold-induced Thermogenesis in Adults From Siberia and Western Europe
1 other identifier
interventional
26
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
1 active site
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
May 17, 2021
CompletedFirst Submitted
Initial submission to the registry
September 21, 2021
CompletedFirst Posted
Study publicly available on registry
November 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2022
CompletedJuly 28, 2022
July 1, 2022
12 months
September 21, 2021
July 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cold-induced thermogenesis
Energy expenditure with indirect calorimetry
30 min before and during the cold exposure (maximum 1 hour)
Secondary Outcomes (4)
Skin temperature
30 min before and during the cold exposure (maximum 1 hour)
Core temperature
30 min before and during the cold exposure (maximum 1 hour)
Shivering activity
30 min before and during the cold exposure (maximum 1 hour)
Substrate oxidation
30 min before and during the cold exposure (maximum 1 hour)
Study Arms (2)
Cold exposure applied to Western European individuals
OTHERParticipants 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
OTHERParticipants 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.
Interventions
Cold air exposure (\~ 9°C, maximum 1 hour duration)
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Western European origin or of Siberian origin
- BMI between 18.5 and 35 kg/m2
- Generally healthy (determined by dependent physician)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University
Maastricht, 6229 ER, Netherlands
Study Officials
- PRINCIPAL INVESTIGATOR
W. van Marken Lichtenbelt, PhD
Maastricht University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2021
First Posted
November 4, 2021
Study Start
May 17, 2021
Primary Completion
May 2, 2022
Study Completion
May 2, 2022
Last Updated
July 28, 2022
Record last verified: 2022-07