The Effect of Cold Exposure on Energy Expenditure

Sponsor

Maastricht University (Other)

Overall Status

Completed

CT.gov ID

NCT05107570

Collaborator

(none)

Enrollment

Location

Arms

11.5

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cold Exposure	Other: Cold exposure	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Cold-induced Thermogenesis in Adults From Siberia and Western Europe

Actual Study Start Date :

May 17, 2021

Actual Primary Completion Date :

May 2, 2022

Actual Study Completion Date :

May 2, 2022

Arms and Interventions

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

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.

Other: Cold exposure

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.

Other: Cold exposure

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

Outcome Measures

Primary Outcome Measures

Cold-induced thermogenesis [30 min before and during the cold exposure (maximum 1 hour)]
Energy expenditure with indirect calorimetry

Secondary Outcome Measures

Skin temperature [30 min before and during the cold exposure (maximum 1 hour)]
Skin temperature determined with iButtons, measured in °C
Core temperature [30 min before and during the cold exposure (maximum 1 hour)]
Core temperature determined with a gastrointestinal pill, measured in °C
Shivering activity [30 min before and during the cold exposure (maximum 1 hour)]
Electromyography will be used to measure the electrical activity of 3 skeletal muscles
Substrate oxidation [30 min before and during the cold exposure (maximum 1 hour)]
Carbohydrate and fat oxidation will be determined with indirect calorimetry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University	Maastricht		Netherlands	6229 ER

Sponsors and Collaborators

Maastricht University

Investigators

Principal Investigator: W. van Marken Lichtenbelt, PhD, Maastricht University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht University

ClinicalTrials.gov Identifier:

NCT05107570

Other Study ID Numbers:

First Posted:

Nov 4, 2021

Last Update Posted:

Jul 28, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maastricht University

Cold exposure

Energy expenditure

Study Results

No Results Posted as of Jul 28, 2022