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Completed

NCT Number: NCT05107570

The Effect of Cold Exposure on Energy Expenditure

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, 6229 ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold exposure

Other

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

Primary outcomes

  1. Cold-induced thermogenesis

    Time frame: 30 min before and during the cold exposure (maximum 1 hour)

    Energy expenditure with indirect calorimetry

Secondary outcomes

  1. Skin temperature

    Time frame: 30 min before and during the cold exposure (maximum 1 hour)

    Skin temperature determined with iButtons, measured in °C

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Registry information

Official study title

Cold-induced Thermogenesis in Adults From Siberia and Western Europe

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2021
Registry last updated
Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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