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Completed

NCT Number: NCT06078345

Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis

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.

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Key information

Conditions

Brown Adipose Tissue Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Dept. of Endocrinology

Basel, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 18.5 to 28 kg/m2
  • Able to give informed consent as documented by signature

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Carbohydrate

Other

400 Kcal glucose (100g oGTT)

fat

Other

400 Kcal glucose rapeseed oil.

Protein

Other

400 Kcal Moltein PURE (111g)

Primary outcomes

  1. 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

Secondary outcomes

  1. AUC Branched chain amino acids

    Time frame: 1h before and 5 hours after nutritional intervention

    AUC of BCAAs after protein load in in participants with functional BAT as compared to participants without functional BAT

  2. AUC triglycerides

    Time frame: 1h before and 5 hours after nutritional intervention

    AUC of plasma triglycerides after lipid test meal in participants with functional BAT as compared to participants without functional BAT.

  3. Diet induced thermogenesis

    Time frame: 1h before and 5 hours after nutritional intervention

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • ETH Zurich (Switzerland)

Registry information

Acronym: BANDIT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 11, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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