Brown Adipose TissueNCT02381483
Vitamin A in Brown Fat Activity
A study testing Cold exposure in people with Brown Adipose Tissue, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Vitamin A metabolites (retinoids) have shown to activate brown fat function in preclinical studies, however the role of retinoids in human brown fat physiology and energy metabolism remains elusive. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Brown Adipose Tissue
- What is being tested?
- Cold exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2014to 15 Apr 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20 - 45 years.
- Body mass index (BMI) 18.5 - 24.9 kg/m2 (lean) or 30.0 - 38.0 kg/m2 (obese)
Who cannot join
- Endocrine (except hyperlipidemia), cardiovascular (except hypertension), liver, kidney, inflammatory bowel, rheumatic, oncologic disease or any other chronic condition.
- Medication for any of the above mentioned conditions.
- Pregnancy
- Metallic implants that are not MRI compatible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Vitamin A in Brown Fat Activity and Energy Metabolism
Vitamin A metabolites (retinoids) have shown to activate brown fat function in preclinical studies, however the role of retinoids in human brown fat physiology and energy metabolism remains elusive. This study aims to identify a possible association between retinoid metabolism, brown fat activity, and energy expenditure in lean and obese subjects by using FDG-PET-CT, PET-MR Scans and indirect calorimetry. Additionally we will analyze the genetic profile of white and brown neck fat biopsies at room temperature and cold conditions in a subset of the study participants. More detailed molecular studies (involving other potential browning markers) will also be performed in adipocytes derived from human SVC.
The optimal duration of cold exposure will be determined in a pilot study. Therefore subjects will be repeatedly exposed to cold and circulating retinoid levels and other plasma parameters will be measured at various time points.
- Conditions
- Brown Adipose Tissue
- Being tested
- Cold exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold exposureOther
| Study group | Role | What they receive |
|---|---|---|
| Lean | Experimental | Cold exposure Receives: Other: Cold exposure |
| Obese | Experimental | Cold exposure Receives: Other: Cold exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between retinol/retinol-binding protein concentrations and cold-induced brown fat acitivity
A possible association between serum retinol and retinol-binding protein concentrations and cold-induced brown fat activity in lean and obese subjects, respectively, will be analyzed.
Measured: 6 years
Secondary outcomes (3)
Analyses of potential BAT or browning markers in humans
Measured: 6 years
Association between BAT activity and energy expenditure
Measured: 6 years
Identification of new factors related to brown fat function
This is a very exploratory aim that involves a number of molecular tests. Therefore no single outcome measure can be defined here. Briefly, we will perform mRNA and miRNA analyses from BAT biopsies and plasma before and after cold exposure to identify new factors related to BAT function. Potential candidates will be tested in loss- or gain-of-function models in isolated human and/or murine adipocytes. In addition, the thermogenic effects of commercially available peptides, hormones, lipids, or steroid acids, will be tested in primary adipocytes.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startFeb 2014
- Primary completion15 Apr 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brown Adipose TissueStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Florian Kiefer, Medical University of Vienna
- Investigators
- Florian Kiefer, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381483
- Sponsor's protocol ID
- 1032/2013
- Status last verified
- Aug 2018
- First submitted
- 14 Feb 2015
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kulterer OC, Herz CT, Pils D, Wollenweber T, Fritzer-Szekeres M, Kautzky-Willer A, Calabretta R, Hagn G, Hacker M, Gerner C, Haug AR, Kiefer FW. Active Brown Adipose Tissue Is Associated With Reduced Arterial Inflammation and Less Atherogenic Circulating Factors in Individuals With Obesity. Arterioscler Thromb Vasc Biol. 2026 Jul;46(7):e324200. doi: 10.1161/ATVBAHA.125.324200. Epub 2026 Apr 30.
PubMed 42059078Kulterer OC, Niederstaetter L, Herz CT, Haug AR, Bileck A, Pils D, Kautzky-Willer A, Gerner C, Kiefer FW. The Presence of Active Brown Adipose Tissue Determines Cold-Induced Energy Expenditure and Oxylipin Profiles in Humans. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa183. doi: 10.1210/clinem/dgaa183.
PubMed 32343312
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Vitamin A in Brown Fat Activity and Energy Metabolism
- ClinicalTrials.gov ID
- NCT02381483
- Acronym / sponsor ID
- 1032/2013
- Conditions
- Brown Adipose Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 6 Mar 2015 (estimated)
- 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.
Vitamin A metabolites (retinoids) have shown to activate brown fat function in preclinical studies, however the role of retinoids in human brown fat physiology and energy metabolism remains elusive. This study aims to identify a possible association between retinoid metabolism, brown fat activity, and energy expenditure in lean and obese subjects by using FDG-PET-CT, PET-MR Scans and indirect calorimetry. Additionally we will analyze the genetic profile of white and brown neck fat biopsies at room temperature and cold conditions in a subset of the study participants. More detailed molecular studies (involving other potential browning markers) will also be performed in adipocytes derived from human SVC.
The optimal duration of cold exposure will be determined in a pilot study. Therefore subjects will be repeatedly exposed to cold and circulating retinoid levels and other plasma parameters will be measured at various time points.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean | Experimental | Other: Cold exposureCold exposure |
| Obese | Experimental | Other: Cold exposureCold exposure |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 20 - 45 years.
- Body mass index (BMI) 18.5 - 24.9 kg/m2 (lean) or 30.0 - 38.0 kg/m2 (obese)
Key exclusion criteria (4 listed)
- Endocrine (except hyperlipidemia), cardiovascular (except hypertension), liver, kidney, inflammatory bowel, rheumatic, oncologic disease or any other chronic condition.
- Medication for any of the above mentioned conditions.
- Pregnancy
- Metallic implants that are not MRI compatible
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 exposure | Other | Lean, Obese |
Primary outcome
Correlation between retinol/retinol-binding protein concentrations and cold-induced brown fat acitivity
Time frame: 6 years
A possible association between serum retinol and retinol-binding protein concentrations and cold-induced brown fat activity in lean and obese subjects, respectively, will be analyzed.
3 secondary outcomes
Analyses of potential BAT or browning markers in humans
Time frame: 6 years
Association between BAT activity and energy expenditure
Time frame: 6 years
Identification of new factors related to brown fat function
Time frame: 6 years
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 20 Aug 2018.
- Derived from this study: PubMed 42059078Kulterer OC, Herz CT, Pils D, Wollenweber T, Fritzer-Szekeres M, Kautzky-Willer A, Calabretta R, Hagn G, Hacker M, Gerner C, Haug AR, Kiefer FW. Active Brown Adipose Tissue Is Associated With Reduced Arterial Inflammation and Less Atherogenic Circulating Factors in Individuals With Obesity. Arterioscler Thromb Vasc Biol. 2026 Jul;46(7):e324200. doi: 10.1161/ATVBAHA.125.324200. Epub 2026 Apr 30.
- Derived from this study: PubMed 32343312Kulterer OC, Niederstaetter L, Herz CT, Haug AR, Bileck A, Pils D, Kautzky-Willer A, Gerner C, Kiefer FW. The Presence of Active Brown Adipose Tissue Determines Cold-Induced Energy Expenditure and Oxylipin Profiles in Humans. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa183. doi: 10.1210/clinem/dgaa183.
Related trials for Brown Adipose Tissue
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
RecruitingPhase 2
Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence
Atrial Fibrillation (AF)
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.
Florian Kiefer, MD, PhD principal investigator
Medical University of Vienna
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 exposure in people with Brown Adipose Tissue, run by Medical University of Vienna at 1 site in Austria.
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 4 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 20 Aug 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 Austria. 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?
Correlation between retinol/retinol-binding protein concentrations and cold-induced brown fat acitivity (time frame: 6 years). 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 NCT02381483, which also lists 2 linked publications.
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 20 Aug 2018.