Intermittent Cold Exposure and Brown Adipose Tissue Hyperplasia
NCT ID: NCT07048405
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
12 participants
INTERVENTIONAL
2025-05-01
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Healthy adults aged 18 to 40 years (6 males and 6 females) will participate in a 10-day cold acclimation protocol (2 hours per day using water-perfused cooling blankets). The primary objective is to determine how cold exposure alters cellular heterogeneity and gene expression in BAT, WAT, and skeletal muscle.
Participants will undergo baseline assessments, including measurements of energy expenditure, core and skin temperature, muscle activity, and blood sampling, each performed in both warm and cold conditions. These assessments will be followed by dynamic total-body PET/CT imaging during cold exposure and tissue biopsies from BAT, subcutaneous WAT, and skeletal muscle. These procedures will be repeated after the cold acclimation protocol to evaluate physiological and molecular changes. Additional outcomes include changes in energy expenditure, cold tolerance, and immune cell responses induced by cold exposure.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cold Induced Activation of Brown Adipose Tissue in Humans
NCT03096535
Does Cold Provocation Increase Brown Adipose Tissue Volume?
NCT01797328
Brown Adipose Tissue Metabolism in Type 2 Diabetes
NCT05092945
Brown Adipose Tissue Activation and Energy Expenditure by Capsinoids Stimulation With Trimodality Imaging Using 18-FDG-PET, Fat Fraction MRI and Infrared Thermography
NCT02964442
Cold Acclimation As a Modulator of Brown Adipose Tissue Function in Adults with Obesity
NCT05468151
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Attend baseline visits in both warm and cold conditions for blood sampling, measurement of energy expenditure, skin and core temperature, muscle activity. This will be followed by dynamic total-body 18F-FDG PET/CT scan during cold exposure.
* Undergo biopsies of BAT (supraclavicular), skeletal muscle (vastus lateralis), and subcutaneous WAT (periumbilical) under local anesthesia.
* Complete 10 consecutive days of cold acclimation (2 hours per day) using water-perfused cooling blankets.
* Return for follow-up assessments, including repeat blood sampling, energy expenditure, temperature measurements, PET/CT imaging, and tissue biopsies to evaluate post-acclimation changes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy normal weight subjects
Cooling
Participants will undergo cold exposure during the baseline and final visits (2.5 hours each visit), as well as throughout the 10-day cold acclimation period (2 hours per day). This will be achieved using water-perfused blankets set to individualized temperatures, selected to elicit comparable physiological responses across participants.
Biopsies
Under local anesthesia, biopsies will be obtained from the following sites:
* Brown adipose tissue from the supraclavicular (collarbone) region, guided by computed tomography (CT).
* White adipose tissue from the abdominal (periumbilical) area.
* Skeletal muscle from the outer thigh, specifically the vastus lateralis.
These biopsies will be performed both before and after the 10-day cold acclimation protocol.
Injection of 18F-FDG
Intravenous injection of 18F-FDG will be performed after 2 hours of cold exposure. This will be followed by a 30min dynamic total PET/CT scan while cold exposed using water-perfused blankets. These procedures will take place before and after the 10 day-cold acclimation protocol.
Indirect calorimetry
Participants will rest quietly while oxygen consumption and carbon dioxide production are continuously recorded using a indirect calorimeter. These data will be used to calculate energy expenditure and respiratory exchange ratio. This procedure will take place before and after the 10 day-cold acclimation protocol.
Electromyogram
Skin surface electrodes will be placed on major skeletal muscles to measure shivering and muscle activity during both warm and cold conditions. This procedure will take place before and after the 10 day-cold acclimation protocol.
Core and skin temperature monitoring
Participants will ingest an electronic capsule that wirelessly and continuously monitors core body temperature. This procedure will be conducted before and after the 10-day cold acclimation protocol.
Additionally, wireless temperature sensors will placed at multiple standardized sites on the body to measure skin temperature. This procedure will be performed before, during, and after the 10-day cold acclimation protocol.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cooling
Participants will undergo cold exposure during the baseline and final visits (2.5 hours each visit), as well as throughout the 10-day cold acclimation period (2 hours per day). This will be achieved using water-perfused blankets set to individualized temperatures, selected to elicit comparable physiological responses across participants.
Biopsies
Under local anesthesia, biopsies will be obtained from the following sites:
* Brown adipose tissue from the supraclavicular (collarbone) region, guided by computed tomography (CT).
* White adipose tissue from the abdominal (periumbilical) area.
* Skeletal muscle from the outer thigh, specifically the vastus lateralis.
These biopsies will be performed both before and after the 10-day cold acclimation protocol.
Injection of 18F-FDG
Intravenous injection of 18F-FDG will be performed after 2 hours of cold exposure. This will be followed by a 30min dynamic total PET/CT scan while cold exposed using water-perfused blankets. These procedures will take place before and after the 10 day-cold acclimation protocol.
Indirect calorimetry
Participants will rest quietly while oxygen consumption and carbon dioxide production are continuously recorded using a indirect calorimeter. These data will be used to calculate energy expenditure and respiratory exchange ratio. This procedure will take place before and after the 10 day-cold acclimation protocol.
Electromyogram
Skin surface electrodes will be placed on major skeletal muscles to measure shivering and muscle activity during both warm and cold conditions. This procedure will take place before and after the 10 day-cold acclimation protocol.
Core and skin temperature monitoring
Participants will ingest an electronic capsule that wirelessly and continuously monitors core body temperature. This procedure will be conducted before and after the 10-day cold acclimation protocol.
Additionally, wireless temperature sensors will placed at multiple standardized sites on the body to measure skin temperature. This procedure will be performed before, during, and after the 10-day cold acclimation protocol.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index 18.5-25 kg/m2
* Weight change of less than 5% in the past 6 months
* No acute or chronic medical conditions
* On no regular medications (other than contraceptives in female participants)
* No claustrophobia
* Alcohol intake ≤14 units/ week
* Screening blood tests within acceptable limits (of no clinical significance)
* Not currently pregnant, lactating or breastfeeding (female participants only)
* Ability to provide informed consent.
* Contra-indication to PET/CT scan
* Allergy to local anaesthetic
18 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Edinburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24/SS/0094
Identifier Type: OTHER
Identifier Source: secondary_id
350117
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.