Adipose TissueCOLDBAT_WSNCT03095846
Cold Induced Activation of Brown Adipose Tissue in Winter Swimmers
A study testing Cooling in people with Adipose Tissue and Brown Adipose Tissue, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study investigates cold-induced brown fat activation in winter swimmers and not-winter swimmers by skin temperature measures assessed with infra red thermography imaging and skin temperatures. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adipose Tissue, Brown Adipose Tissue, Brown Fat
- What is being tested?
- Cooling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-35 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. Winter swimmers: Min. 2 swim/ week. Swimming in winter-season in open water outdoor in Denmark from September/October until study start in March.
- Not-winter swimmers: Not winter-swimmers or taken cold showers on a regular basis.
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. 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, in the preliminary investigation.
- Use of daily medications, except for seasonal use of antihistamines. Diagnosed sleep disturbances.
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 Winter Swimmers
This study investigates cold-induced brown fat activation in winter swimmers and not-winter swimmers by skin temperature measures assessed with infra red thermography imaging and skin temperatures. Winter swimmers and not-winter swimmers will participate in an acute cooling intervention and thermoneutral intervention for comparison of energy expenditure and skin temperatures at the supraclavicular area.
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.
Cold induced brown fat activity will be measured by skin temperature measures by means of infra-red thermography imaging and skin temperature.
15 healthy male winter swimmers and 8 healthy male non-winter swimmers (controls) will be included in the study.
- Conditions
- Adipose Tissue, Brown Adipose Tissue, Brown Fat, Uncoupling Protein 1, Adipokines, Proteomics
- Being tested
- Cooling
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
| Study group | Role | What they receive |
|---|---|---|
| Winter Swimmers | Experimental | Individualized cooling protocol Receives: Procedure: Cooling |
| Not-winter Swimmers | Experimental | Individualized cooling protocol Receives: Procedure: Cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
5. Difference in brown adipose tissue (BAT) activity after cooling between Winter Swimmers (WS) and No-Winter Swimmers (NWS).
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 is calculated.
Measured: Difference in peak temperature after 2 hours of cooling.
Secondary outcomes (2)
Difference in glucose control between WS and NWS.
Difference in glucose control between WS and NWS in an oral glucose tolerance test measured as incremental area under the curve (iAUC).
Measured: Difference in glucose control between WS and NWS after a 2 hours glucose tolerance test under thermoneutral conditions.
Difference in resting energy expenditure after cooling versus no cooling
Difference in resting energy expenditure after cooling versus no cooling between WS and NWS measured as mean difference in kilojoule per minute.
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.
- Other trials for Adipose TissueStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT03095846
- Sponsor's protocol ID
- H-16038581-COLDBAT_WS
- Acronym
- COLDBAT_WS
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Induced Activation of Brown Fat in Winter Swimmers
- ClinicalTrials.gov ID
- NCT03095846
- Acronym / sponsor ID
- COLDBAT_WS / H-16038581-COLDBAT_WS
- Conditions
- Adipose Tissue, Brown Adipose Tissue, Brown Fat, Uncoupling Protein 1, Adipokines, Proteomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, 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 in winter swimmers and not-winter swimmers by skin temperature measures assessed with infra red thermography imaging and skin temperatures. Winter swimmers and not-winter swimmers will participate in an acute cooling intervention and thermoneutral intervention for comparison of energy expenditure and skin temperatures at the supraclavicular area.
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.
Cold induced brown fat activity will be measured by skin temperature measures by means of infra-red thermography imaging and skin temperature.
15 healthy male winter swimmers and 8 healthy male non-winter swimmers (controls) will be included in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Winter Swimmers | Experimental | Procedure: CoolingIndividualized cooling protocol |
| Not-winter Swimmers | Experimental | Procedure: CoolingIndividualized cooling protocol |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-35 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. Winter swimmers: Min. 2 swim/ week. Swimming in winter-season in open water outdoor in Denmark from September/October until study start in March.
- Not-winter swimmers: Not winter-swimmers or taken cold showers on a regular basis.
Key exclusion criteria (6 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.
- Alcohol consumption >14 units/week. 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, in the preliminary investigation.
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 | Not-winter Swimmers, Winter Swimmers |
Primary outcome
5. Difference in brown adipose tissue (BAT) activity after cooling between Winter Swimmers (WS) and No-Winter Swimmers (NWS).
Time frame: Difference in peak temperature after 2 hours of 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 is calculated.
2 secondary outcomes
Difference in glucose control between WS and NWS.
Time frame: Difference in glucose control between WS and NWS after a 2 hours glucose tolerance test under thermoneutral conditions.
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 27 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Adipose Tissue
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
RecruitingObservational study
Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism
Brown Adipose Tissue (BAT) Physiology, Phenotyping
RecruitingPhase 4
Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction
Heart Failure Preserved Ejection Fraction, Epicardial Adipose Tissue
RecruitingPhase 1/2
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
Adipocytic Neoplasm, Liposarcoma
Not yet recruiting
Brown Adipose Tissue as a Mechanistic Determinant of Semaglutide Treatment Response in Obesity (BAT-Sema Study)
Obesity, Metabolic Syndrome
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 in people with Adipose Tissue and Brown Adipose Tissue, run by Copenhagen University Hospital, Rigshospitalet 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 2 inclusion and 6 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 27 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?
5. Difference in brown adipose tissue (BAT) activity after cooling between Winter Swimmers (WS) and No-Winter Swimmers (NWS). (time frame: Difference in peak temperature after 2 hours of cooling.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.