NCT06078345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 12, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

October 5, 2023

Last Update Submit

November 24, 2025

Conditions

Keywords

Diet induced thermogenesisCold exposureEnergy Expenditure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • AUC Branched chain amino acids

    1h before and 5 hours after nutritional intervention

  • AUC triglycerides

    1h before and 5 hours after nutritional intervention

  • Diet induced thermogenesis

    1h before and 5 hours after nutritional intervention

Study Arms (2)

BAT positive

EXPERIMENTAL

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

Other: CarbohydrateOther: FatOther: Protein

BAT negative

EXPERIMENTAL

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

Other: CarbohydrateOther: FatOther: Protein

Interventions

400 Kcal glucose (100g oGTT)

BAT negativeBAT positive
FatOTHER

400 Kcal glucose rapeseed oil.

BAT negativeBAT positive
ProteinOTHER

400 Kcal Moltein PURE (111g)

BAT negativeBAT positive

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Dept. of Endocrinology

Basel, Switzerland

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

CarbohydratesCD36 AntigensProteins

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Platelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Officials

  • Matthias J Betz, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Prospective interventional trial in healthy volunteers with random sequence of the three study interventions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

October 12, 2023

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations