Brown Adipose Tissue, HumanNCT01797328
Does Cold Provocation Increase Brown Adipose Tissue Volume?
A study testing cold arm and warm arm in people with Brown Adipose Tissue, Human, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of ability to avoid feeling cold, for 6 weeks. Basal metabolic rate and magnetic resonance (for determination of brown adipose tissue volume) imaging are performed before and after the study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Brown Adipose Tissue, Human
- What is being tested?
- cold arm and warm arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Exclusion Criteria: any significant disease, ot other conditions that interferes with magnetic resonance imaging
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effects of Temperature on Amount of Brown Adipose Tissue in Humans
About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of ability to avoid feeling cold, for 6 weeks. Basal metabolic rate and magnetic resonance (for determination of brown adipose tissue volume) imaging are performed before and after the study.
- Conditions
- Brown Adipose Tissue, Human
- Being tested
- cold arm, warm arm
- Keywords
- brown adipose tissue, human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold armProcedure or surgery
1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering
warm armProcedure or surgery
To the best of ability avoid feeling cold during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| cold provocation | Active comparator | cold arm Receives: Procedure: cold arm |
| to avoid feeling cold | Active comparator | warm arm Receives: Procedure: warm arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brown Adipose Tissue, Absolute Volume
Sub-clavicular brown adipose tissue volume by magnetic resonance imaging (liters)
Measured: Baseline and 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brown Adipose Tissue, HumanStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik H Nystrom, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797328
- Sponsor's protocol ID
- Nystrom_koldstudie
- Other IDs
- Dnr2013/41-32
- Status last verified
- Apr 2017
- First submitted
- 18 Feb 2013
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Temperature on Amount of Brown Adipose Tissue in Humans
- ClinicalTrials.gov ID
- NCT01797328
- Acronym / sponsor ID
- Nystrom_koldstudie
- Conditions
- Brown Adipose Tissue, Human
- Keywords
- brown adipose tissue, human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of ability to avoid feeling cold, for 6 weeks. Basal metabolic rate and magnetic resonance (for determination of brown adipose tissue volume) imaging are performed before and after the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold provocation | Active comparator | Procedure: cold armcold arm |
| to avoid feeling cold | Active comparator | Procedure: warm armwarm arm |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: any significant disease, ot other conditions that interferes with magnetic resonance imaging
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| cold arm1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering | Procedure or surgery | cold provocation |
| warm armTo the best of ability avoid feeling cold during 6 weeks | Procedure or surgery | to avoid feeling cold |
Primary outcome
Brown Adipose Tissue, Absolute Volume
Time frame: Baseline and 6 week
Sub-clavicular brown adipose tissue volume by magnetic resonance imaging (liters)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for 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
Recruiting
Intermittent Cold Exposure and Brown Adipose Tissue Hyperplasia
Brown Adipose Tissue, Cold Exposure
Active, not recruiting
BATokines as Biomarkers of Brown Fat in Humans
Healthy Lifestyle
Active, not recruiting
Adaptation of Human Brown Adipose Tissue to Calorie Restriction
Obesity and Overweight
Recruiting
Postnatal Exercise to Activate Baby's Brown Fat
Childhood Obesity Prevention, Childhood Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold arm and warm arm in people with Brown Adipose Tissue, Human, run by University Hospital, Linkoeping at 1 site in Sweden.
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 0 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 25 Apr 2017. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Brown Adipose Tissue, Absolute Volume (time frame: Baseline and 6 week). 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 25 Apr 2017.