Effect of Caffeine on Cold-stimulated Brown Adipose Tissue Activity

NCT06978777 | Recruiting

• 1 other identifier: ACROBAT_V1_1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to asses brown adipose tissue activity after a cold mild stimulus, preceded by 200mg caffeine or placebo administration.

Conditions

Brown Adipose Tissue (BAT) Physiology; Cold Exposure

Outcome Measures

Primary Outcomes (1)

• BAT SUVmean

  Description: 18F-FDG uptake into the supra-clavicular brown adipose tissue as determined by 18F-FDG PET-CT after the respective study intervention

  30 minutes after end of intervention in study visit A and B.

Secondary Outcomes (8)

• BAT SUVmax

  30 minutes after intervention in study visit A and B.

• BAT Volume

  30 minutes after intervention in study visit A and B.

• Cold induced thermogenesis (CIT)

  immediately after the intervention (caffeine or placebo)

• Resting energy expenditure (REE)

  immediately after the intervention (caffeine or placebo)

• Respiratory exchange ratio (RER):

  immediately after the intervention (caffeine or placebo)

Study Arms (2)

Caffeine

ACTIVE COMPARATOR

Participants will be administered a single dose of 200mg caffeine orally in study visite A, before exposing to a mild cold stimulus. Resting energy expenditure will be measured before an after administration of caffeine and cold exposure.

Drug: Caffeine (200 mg)

Placebo

PLACEBO COMPARATOR

Participants will be administered a single dose of placebo tablet orally in study visite B, before exposing to a mild cold stimulus. Resting energy expenditure will be measured before an after administration of placebo and cold exposure.

Drug: Placebo

Interventions

Caffeine (200 mg) DRUG

single dose of 200mg caffeine orally in study visit A

Caffeine

Placebo DRUG

single dose of 1 tablet Placebo in study visit B

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18.5 to 25 kg/m2
• Able to give informed consent as documented by signature
• Moderate caffeine consumption (1 to 3 cups of coffee per day)
• Increase of EE in response to mild cold of ≥ 5% of REE

You may not qualify if:

• Known hypersensitivity or allergy to caffeine
• 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, cardiac arrhythmia, hypertension, diabetes mellitus, hyper- or hypothyroidism)
• History of depressive disorder or anxiety disorder
• Smoker / habitual tobacco use
• Habitual excessive alcohol use
• Regular consumption of caffeine containing energy drinks
• Systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 95 mmHg.
• Resting heart rate \>90 bpm
• 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.
• Pregnancy or lactation

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Department of Endocrinology

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Matthias Betz, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Betz, Prof.

CONTACT

0041 61 556 56 54; Matthias.Betz@usb.ch

Jaël Senn, MD

CONTACT

0041 61 328 70 79; jaelrut.senn@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled cross-over trial in healthy volunteers with random sequence of the two study interventions.

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 18, 2025
• Study Start: January 21, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)