Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis

Metabolic Disease Clinical Trial

— BANDIT  

Official title:

Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078345
• Other study ID #: EKNZ 2023-01544
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Matthias J Betz, MD
• Phone: 0041 61 556 56 54
• Email: matthias.betz[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Brown Adipose Tissue
• Metabolic Disease
• Metabolic Diseases

Intervention

Other:
• Carbohydrate
400 Kcal glucose (100g oGTT)
• Fat
400 Kcal glucose rapeseed oil.
• Protein
400 Kcal Moltein PURE (111g)

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Dept. of Endocrinology	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	ETH Zurich (Switzerland)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1h before and 5 hours after nutritional intervention
Secondary	AUC Branched chain amino acids	AUC of BCAAs after protein load in in participants with functional BAT as compared to participants without functional BAT	1h before and 5 hours after nutritional intervention
Secondary	AUC triglycerides	AUC of plasma triglycerides after lipid test meal in participants with functional BAT as compared to participants without functional BAT.	1h before and 5 hours after nutritional intervention
Secondary	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.	1h before and 5 hours after nutritional intervention