Adipose Tissue, BrownCOLDBATNCT03096535
Cold Induced Activation of Brown Adipose Tissue in Humans
A study testing Cooling and Thermoneutral in people with Adipose Tissue, Brown and Brown Adipose Tissue, run by Susanna Søberg at 1 site in Denmark.
Trial summary
This study investigates cold-induced brown fat activation assessed using PET/MR scans. Subjects will participate in an acute cooling intervention day and a thermoneutral intervention day with PET/MR scans on both days. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adipose Tissue, Brown, Brown Adipose Tissue, Brown Fat
- What is being tested?
- Cooling and Thermoneutral
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Apr 2017to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-30 years.
- Men
- Caucasian white
- Body Mass Index 19-25 kg/m2.
- Moderate physical activity level (not more than 8-10 hours of training pr. Week)
- Ability to give informed consent.
- Ability to follow verbal and written instructions in Danish.
- Body fat percent under 21% measured at the pre-examination day.
Who cannot join
- Chronic diseases: Hormonal: Metabolic Diseases mb. Graves, hypothyroidism, myxedema and goiter. Diabetes Melitus, Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure), cancer treated within last 3 years.
- Tobacco, marijuana or intravenous drug use within 1 year of screening.
- Dieting, recent weight loss (>3 kg within 3 month) or a history of an eating disorder.
- Dietary supplements.
- History of depression, psychosis, or other psychiatric illness requiring hospitalization.
- Alcohol consumption >14 units/week.
Show all 17Show fewer
- History of alcohol abuse within the past 3 years.
- Known liver disease or elevated liver biomarkers more than 2 times upper normal levels in the preliminary investigation.
- Known kidney disease or elevated kidney biomarkers, eCRF <60 ml/min, in the preliminary investigation.
- Use of daily medications, except for seasonal use of antihistamines.
- Diagnosed sleep disturbances.
- Pacemaker or other electronics implanted in the body.
- Magnetic impressionable metal implants or foreign objects in the body inconsistent with completion of MR.
- Claustrophobia
- Communication problems, including understanding the experimental protocol
- History of contrast allergy.
- Winter swimmers.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Inflammation and Metabolism/ Center for Physical Activity Research
Copenhagen, 2100
About this study
Official title: Cold Induced Activation of Brown Fat in Humans Assessed With PET/MR Scans and Skin-temperature Measure - A Cross-over Randomized Controlled Trial.
This study investigates cold-induced brown fat activation assessed using PET/MR scans. Subjects will participate in an acute cooling intervention day and a thermoneutral intervention day with PET/MR scans on both days. A secondary purpose is to make a validation of an infrared thermography camera by comparison of skin temperatures and SUV of the supraclavicular brown adipose tissue.
Read the detailed description
The field of human brown adipose tissue (BAT) research is focused on activation of BAT as a means of manipulating energy expenditure and potentially anti-obesity and anti-diabetic properties of the tissue. This is well established in rodent studies and explained as due to the specific brown fat uncoupling protein 1 (UCP1). Despite increasing evidence that indicates a metabolic regulatory role of BAT in humans, BAT activation/recruitment is not fully understood and even less is known about the endocrine capacities of human BAT.
Cold induced brown fat activity will be assessed with PET/MR scans and validate an infra-red thermography camera, as well as perform a proteomic screening using blood samples under these two intervention days.
15 healthy lean male subjects will serve as their own control in a cross-over randomized control study, including a pre-examination day, a thermoneutral-day and a cooling test-day with cold exposure followed by a PET/MR scan to determine BAT activity. An extra cooling day is applied for the external validation of the infrared thermography camera. Blood samples and abdominal fat-biopsies will be taken at thermoneutral condition and under cold stimulation of brown fat.
- Conditions
- Adipose Tissue, Brown, Brown Adipose Tissue, Brown Fat, Uncoupling Protein 1, Adipokines, Proteomics
- Being tested
- Cooling, Thermoneutral
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolingProcedure or surgery
Also called Cold activation, Cold stimulation, Cold activation of BAT
Individualized cooling protocol.
ThermoneutralProcedure or surgery
Thermoneutral control day.
| Study group | Role | What they receive |
|---|---|---|
| Cooling | Experimental | Individualized cooling protocol. Receives: Procedure: Cooling |
| Thermoneutral | Experimental | Thermoneutral condition day. Receives: Procedure: Thermoneutral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in brown adipose tissue (BAT) activity after cooling versus no cooling.
BAT activity is measured by standard fluorodeoxyglukose uptake volume (SUV mean) in the supraclavicular BAT depot using PET/MR scans. Difference between scans performed after 2 hours of cooling and 2 hours of no cooling is calculated.
Measured: Difference in SUV mean after 2 hours of cooling versus 2 hours of no cooling.
Secondary outcomes (2)
Difference in BAT activity after cooling versus no cooling.
BAT activity is measured by skin temperature in the supraclavicular BAT depot using infrared thermography imaging. Difference between peak temperature change (peak temperature minus baseline temperature) during 2 hours of cooling and 2 hours of no cooling is calculated.
Measured: Difference in peak temperature after 2 hours of cooling versus 2 hours of no cooling.
Difference in resting energy expenditure after cooling versus no cooling
Difference in resting energy expenditure after cooling versus no cooling, measured as mean difference in KJ/min.
Measured: Difference in resting energy expenditure after 2 hours of cooling versus 2 hours of no cooling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start2 Apr 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adipose Tissue, BrownStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanna Søberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susanna Søberg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Susanna Søberg, MSc., Principal investigator, Center for Inflammation and Metabolism/Center for physical activity research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096535
- Sponsor's protocol ID
- H-16038581-COLDBAT
- Acronym
- COLDBAT
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2017
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soberg S, Lofgren J, Philipsen FE, Jensen M, Hansen AE, Ahrens E, Nystrup KB, Nielsen RD, Solling C, Wedell-Neergaard AS, Berntsen M, Loft A, Kjaer A, Gerhart-Hines Z, Johannesen HH, Pedersen BK, Karstoft K, Scheele C. Altered brown fat thermoregulation and enhanced cold-induced thermogenesis in young, healthy, winter-swimming men. Cell Rep Med. 2021 Oct 11;2(10):100408. doi: 10.1016/j.xcrm.2021.100408. eCollection 2021 Oct 19.
PubMed 34755128
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Induced Activation of Brown Fat in Humans Assessed With PET/MR Scans and Skin-temperature Measure - A Cross-over Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03096535
- Acronym / sponsor ID
- COLDBAT / H-16038581-COLDBAT
- Conditions
- Adipose Tissue, Brown, Brown Adipose Tissue, Brown Fat, Uncoupling Protein 1, Adipokines, Proteomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Susanna SøbergUniversity, hospital or other
- Study start
- 2 Apr 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates cold-induced brown fat activation assessed using PET/MR scans. Subjects will participate in an acute cooling intervention day and a thermoneutral intervention day with PET/MR scans on both days. A secondary purpose is to make a validation of an infrared thermography camera by comparison of skin temperatures and SUV of the supraclavicular brown adipose tissue.
Detailed description
The field of human brown adipose tissue (BAT) research is focused on activation of BAT as a means of manipulating energy expenditure and potentially anti-obesity and anti-diabetic properties of the tissue. This is well established in rodent studies and explained as due to the specific brown fat uncoupling protein 1 (UCP1). Despite increasing evidence that indicates a metabolic regulatory role of BAT in humans, BAT activation/recruitment is not fully understood and even less is known about the endocrine capacities of human BAT.
Cold induced brown fat activity will be assessed with PET/MR scans and validate an infra-red thermography camera, as well as perform a proteomic screening using blood samples under these two intervention days.
15 healthy lean male subjects will serve as their own control in a cross-over randomized control study, including a pre-examination day, a thermoneutral-day and a cooling test-day with cold exposure followed by a PET/MR scan to determine BAT activity. An extra cooling day is applied for the external validation of the infrared thermography camera. Blood samples and abdominal fat-biopsies will be taken at thermoneutral condition and under cold stimulation of brown fat.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooling | Experimental | Procedure: CoolingIndividualized cooling protocol. |
| Thermoneutral | Experimental | Procedure: ThermoneutralThermoneutral condition day. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-30 years.
- Men
- Caucasian white
- Body Mass Index 19-25 kg/m2.
- Moderate physical activity level (not more than 8-10 hours of training pr. Week)
Key exclusion criteria (17 listed)
- Chronic diseases: Hormonal: Metabolic Diseases mb. Graves, hypothyroidism, myxedema and goiter. Diabetes Melitus, Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure), cancer treated within last 3 years.
- Tobacco, marijuana or intravenous drug use within 1 year of screening.
- Dieting, recent weight loss (>3 kg within 3 month) or a history of an eating disorder.
- Dietary supplements.
- History of depression, psychosis, or other psychiatric illness requiring hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoolingAlso: Cold activation, Cold stimulation, Cold activation of BATIndividualized cooling protocol. | Procedure or surgery | Cooling |
| ThermoneutralThermoneutral control day. | Procedure or surgery | Thermoneutral |
Primary outcome
Difference in brown adipose tissue (BAT) activity after cooling versus no cooling.
Time frame: Difference in SUV mean after 2 hours of cooling versus 2 hours of no cooling.
BAT activity is measured by standard fluorodeoxyglukose uptake volume (SUV mean) in the supraclavicular BAT depot using PET/MR scans. Difference between scans performed after 2 hours of cooling and 2 hours of no cooling is calculated.
2 secondary outcomes
Difference in BAT activity after cooling versus no cooling.
Time frame: Difference in peak temperature after 2 hours of cooling versus 2 hours of no cooling.
Difference in resting energy expenditure after cooling versus no cooling
Time frame: Difference in resting energy expenditure after 2 hours of cooling versus 2 hours of no cooling.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Derived from this study: PubMed 34755128Soberg S, Lofgren J, Philipsen FE, Jensen M, Hansen AE, Ahrens E, Nystrup KB, Nielsen RD, Solling C, Wedell-Neergaard AS, Berntsen M, Loft A, Kjaer A, Gerhart-Hines Z, Johannesen HH, Pedersen BK, Karstoft K, Scheele C. Altered brown fat thermoregulation and enhanced cold-induced thermogenesis in young, healthy, winter-swimming men. Cell Rep Med. 2021 Oct 11;2(10):100408. doi: 10.1016/j.xcrm.2021.100408. eCollection 2021 Oct 19.
- Individual participant dataSharing planned: No
Related trials for Adipose Tissue, Brown
RecruitingObservational study
A Multi-modal Cohort Study of Brown Adipose Tissue Based on Paired Comparisons at Room Temperature and After Cold Exposure
Brown Adipose Tissue, Human
RecruitingPhase 4
Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Not yet recruiting
Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women
Cardiometabolic Diseases, Postmenopause
RecruitingObservational study
Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism
Brown Adipose Tissue (BAT) Physiology, Phenotyping
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna Søberg, MSc. principal investigator
Center for Inflammation and Metabolism/Center for physical activity research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling and Thermoneutral in people with Adipose Tissue, Brown and Brown Adipose Tissue, run by Susanna Søberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in brown adipose tissue (BAT) activity after cooling versus no cooling. (time frame: Difference in SUV mean after 2 hours of cooling versus 2 hours of no cooling.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.