NCT05107570

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

September 21, 2021

Last Update Submit

July 26, 2022

Conditions

Keywords

Cold exposureEnergy expenditure

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

OTHER

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 exposure applied to Siberian individuals

OTHER

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

Interventions

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

Cold exposure applied to Siberian individualsCold exposure applied to Western European individuals

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • W. van Marken Lichtenbelt, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

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

Locations