Brown Adipose TissueBANDITNCT06078345
Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis
A study testing Carbohydrate, Fat and Protein in people with Brown Adipose Tissue and Metabolic Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
To test the hypothesis that active BAT improves metabolic health by buffering postprandial metabolites plasma metabolites and energy expenditure will be compared in volunteers with and without active BAT. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Brown Adipose Tissue, Metabolic Disease
- What is being tested?
- Carbohydrate, Fat and Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Oct 2023to 15 Aug 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5 to 28 kg/m2
- Able to give informed consent as documented by signature
Who cannot join
- Concomitant medication other than prescription free analgesics (paracetamol and NSAID) and oral contraceptives
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus)
- Hyper- or hypothyroidism
- Smoker / habitual tobacco use
- Weight change of >5% within 3 months prior to inclusion
- Hypersensitivity to cold (e.g. Raynaud syndrome)
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- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Enrolment into another study using ionizing radiation within the previous 12 months
- Enrolment into another study including a pharmacological or nutritional intervention
- Pregnancy or lactation
- Lab parameters
- Serum-Creatinine: above 1.5x upper limit of normal (ULN)
- Glycated Hemoglobin (HbA1c): above 6.0%
- Random plasma glucose >11 mM
Trial locations and contacts
1 site in 1 country.
About this study
To test the hypothesis that active BAT improves metabolic health by buffering postprandial metabolites plasma metabolites and energy expenditure will be compared in volunteers with and without active BAT. Both groups will receive test meals with protein, fat and carbohydrates separately, so that the individual impacts of these macronutrients on diet induced thermogenesis and the buffering function of BAT can be derived. BAT biopsies will be taken before and after the test meals for molecular analysis.
Read the detailed description
In this prospective interventional study healthy individuals will be screened for presence of active BAT: Maximal BAT activity will be achieved by a mild cold stimulus over 2 hous and quantified by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG.
Individuals with FDG-PET positive BAT will be included as BAT-positive subjects (n=15) and individuals with absence of FDG-positive BAT will be included as BAT-negative subjects (n=15) and then take part in three study visits in random order.
During the study visits participants will consume a standardized isocaloric liquid meal consisting of A) glucose (OGTT) B) fat and C) protein.
Energy expenditure will be measured by indirect calorimetry before as well as hourly after the meal for 5 hours. Blood samples will be taken before and at 30 minute intervals after the meal for 5 hours for analysis of blood glucose, triglycerides, FAAs, representative amino acids, insulin and noradrenaline.
Subjects will undergo ultrasound-guided biopsy of the supraclavicular fat depot in the fasting state and after one of the test meals so that biopsies from 5 individuals in each group after each test meal will be obtained.
- Conditions
- Brown Adipose Tissue, Metabolic Disease
- Being tested
- Carbohydrate, Fat, Protein
- Keywords
- Diet induced thermogenesis, Cold exposure, Energy Expenditure
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbohydrateOther
400 Kcal glucose (100g oGTT)
FatOther
400 Kcal glucose rapeseed oil.
ProteinOther
400 Kcal Moltein PURE (111g)
| Study group | Role | What they receive |
|---|---|---|
| BAT positive | Experimental | Maximal activated supraclavicular BAT SUVmean >1,5 g/ml- Receives: Other: Carbohydrate; Other: Fat; Other: Protein |
| BAT negative | Experimental | Maximal activated supraclavicular BAT SUVmean <1,5 g/ml Receives: Other: Carbohydrate; Other: Fat; Other: Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC Glucose
Area under the curve (AUC) of glucose after the oral glucose load in participants with functional BAT as compared to participants without functional BAT
Measured: 1h before and 5 hours after nutritional intervention
Secondary outcomes (3)
AUC Branched chain amino acids
AUC of BCAAs after protein load in in participants with functional BAT as compared to participants without functional BAT
Measured: 1h before and 5 hours after nutritional intervention
AUC triglycerides
AUC of plasma triglycerides after lipid test meal in participants with functional BAT as compared to participants without functional BAT.
Measured: 1h before and 5 hours after nutritional intervention
Diet induced thermogenesis
Diet-induced thermogenesis: AUC of EE above RMR in response to the respective macronutrient (carbohydrate, protein or fat). Measured by indirect calorimetry. The results for each macronutrient will be compared between the BAT positive and BAT negative participants.
Measured: 1h before and 5 hours after nutritional intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start12 Oct 2023
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brown Adipose TissueStudies 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
- Model description
- Prospective interventional trial in healthy volunteers with random sequence of the three study interventions.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich (Switzerland)
- Responsible party
- Sponsor
- Investigators
- Matthias J Betz, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078345
- Sponsor's protocol ID
- EKNZ 2023-01544
- Acronym
- BANDIT
- Status last verified
- Nov 2025
- First submitted
- 5 Oct 2023
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis
- ClinicalTrials.gov ID
- NCT06078345
- Acronym / sponsor ID
- BANDIT / EKNZ 2023-01544
- Conditions
- Brown Adipose Tissue, Metabolic Disease
- Keywords
- Diet induced thermogenesis, Cold exposure, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- ETH Zurich (Switzerland)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 11 Oct 2023 (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.
To test the hypothesis that active BAT improves metabolic health by buffering postprandial metabolites plasma metabolites and energy expenditure will be compared in volunteers with and without active BAT. Both groups will receive test meals with protein, fat and carbohydrates separately, so that the individual impacts of these macronutrients on diet induced thermogenesis and the buffering function of BAT can be derived. BAT biopsies will be taken before and after the test meals for molecular analysis.
Detailed description
In this prospective interventional study healthy individuals will be screened for presence of active BAT: Maximal BAT activity will be achieved by a mild cold stimulus over 2 hous and quantified by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG.
Individuals with FDG-PET positive BAT will be included as BAT-positive subjects (n=15) and individuals with absence of FDG-positive BAT will be included as BAT-negative subjects (n=15) and then take part in three study visits in random order.
During the study visits participants will consume a standardized isocaloric liquid meal consisting of A) glucose (OGTT) B) fat and C) protein.
Energy expenditure will be measured by indirect calorimetry before as well as hourly after the meal for 5 hours. Blood samples will be taken before and at 30 minute intervals after the meal for 5 hours for analysis of blood glucose, triglycerides, FAAs, representative amino acids, insulin and noradrenaline.
Subjects will undergo ultrasound-guided biopsy of the supraclavicular fat depot in the fasting state and after one of the test meals so that biopsies from 5 individuals in each group after each test meal will be obtained.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective interventional trial in healthy volunteers with random sequence of the three study interventions.
| Arm | Type | Receives |
|---|---|---|
| BAT positive | Experimental | Other: Carbohydrate, Other: Fat, Other: ProteinMaximal activated supraclavicular BAT SUVmean >1,5 g/ml- |
| BAT negative | Experimental | Other: Carbohydrate, Other: Fat, Other: ProteinMaximal activated supraclavicular BAT SUVmean <1,5 g/ml |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18.5 to 28 kg/m2
- Able to give informed consent as documented by signature
Key exclusion criteria (16 listed)
- Concomitant medication other than prescription free analgesics (paracetamol and NSAID) and oral contraceptives
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus)
- Hyper- or hypothyroidism
- Smoker / habitual tobacco use
- Weight change of >5% within 3 months prior to inclusion
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 |
|---|---|---|
| Carbohydrate400 Kcal glucose (100g oGTT) | Other | BAT negative, BAT positive |
| Fat400 Kcal glucose rapeseed oil. | Other | BAT negative, BAT positive |
| Protein400 Kcal Moltein PURE (111g) | Other | BAT negative, BAT positive |
Primary outcome
AUC Glucose
Time frame: 1h before and 5 hours after nutritional intervention
Area under the curve (AUC) of glucose after the oral glucose load in participants with functional BAT as compared to participants without functional BAT
3 secondary outcomes
AUC Branched chain amino acids
Time frame: 1h before and 5 hours after nutritional intervention
AUC triglycerides
Time frame: 1h before and 5 hours after nutritional intervention
Diet induced thermogenesis
Time frame: 1h before and 5 hours after nutritional intervention
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 25 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Matthias J Betz, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate, Fat and Protein in people with Brown Adipose Tissue and Metabolic Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 16 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 Nov 2025. 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 Switzerland. 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?
AUC Glucose (time frame: 1h before and 5 hours after nutritional intervention). 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 Nov 2025.