Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis

NCT ID: NCT06078345

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2025-08-15

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

BAT positive

Maximal activated supraclavicular BAT SUVmean \>1,5 g/ml-

Group Type: EXPERIMENTAL

Carbohydrate

Intervention Type: OTHER

400 Kcal glucose (100g oGTT)

Fat

Intervention Type: OTHER

400 Kcal glucose rapeseed oil.

Protein

Intervention Type: OTHER

400 Kcal Moltein PURE (111g)

BAT negative

Maximal activated supraclavicular BAT SUVmean \<1,5 g/ml

Group Type: EXPERIMENTAL

Carbohydrate

Intervention Type: OTHER

400 Kcal glucose (100g oGTT)

Fat

Intervention Type: OTHER

400 Kcal glucose rapeseed oil.

Protein

Intervention Type: OTHER

400 Kcal Moltein PURE (111g)

Interventions

Carbohydrate

400 Kcal glucose (100g oGTT)

Intervention Type: OTHER

Fat

400 Kcal glucose rapeseed oil.

Intervention Type: OTHER

Protein

400 Kcal Moltein PURE (111g)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ETH Zurich (Switzerland)

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias J Betz, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel, Dept. of Endocrinology

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

EKNZ 2023-01544

Identifier Type: -

Identifier Source: org_study_id