The Effect of Cold Exposure on Energy Expenditure

Cold Exposure Clinical Trial

Official title:

Cold-induced Thermogenesis in Adults From Siberia and Western Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05107570
• Other study ID #: WEU
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: May 2, 2022

Study information

• Verified date: July 2022
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cold Exposure

Intervention

Other:
• Cold exposure
Cold air exposure (~ 9°C, maximum 1 hour duration)

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cold-induced thermogenesis	Energy expenditure with indirect calorimetry	30 min before and during the cold exposure (maximum 1 hour)
Secondary	Skin temperature	Skin temperature determined with iButtons, measured in °C	30 min before and during the cold exposure (maximum 1 hour)
Secondary	Core temperature	Core temperature determined with a gastrointestinal pill, measured in °C	30 min before and during the cold exposure (maximum 1 hour)
Secondary	Shivering activity	Electromyography will be used to measure the electrical activity of 3 skeletal muscles	30 min before and during the cold exposure (maximum 1 hour)
Secondary	Substrate oxidation	Carbohydrate and fat oxidation will be determined with indirect calorimetry	30 min before and during the cold exposure (maximum 1 hour)