Effect of Caffeine on Cold-stimulated Brown Adipose Tissue Activity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity Hospital, Basel, Switzerland
About this trial
The purpose of the study is to asses brown adipose tissue activity after a cold mild stimulus, preceded by 200mg caffeine or placebo administration.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Caffeine (200 mg)
Drugsingle dose of 200mg caffeine orally in study visit A
Placebo
Drugsingle dose of 1 tablet Placebo in study visit B
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: CaffeineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
30 minutes after end of intervention in study visit A and B.Secondary outcomes
1
BAT SUVmax
maximum SUV in supraclavicular adipose tissue (according to BARCIST 1.0) as determined by 18F-FDG PET-CT after the respective study intervention
Time frame
30 minutes after intervention in study visit A and B.2
BAT Volume
volume of supraclavicular adipose tissue (according to BARCIST 1.0) as determined by 18F-FDG PET-CT after the respective study intervention.
Time frame
30 minutes after intervention in study visit A and B.3
Cold induced thermogenesis (CIT)
rise in energy expenditure above baseline occurring during mild cold exposure in the respective study intervention.
Time frame
immediately after the intervention (caffeine or placebo)4
Resting energy expenditure (REE)
REE during warm conditions and at the end of cold exposure.
Time frame
immediately after the intervention (caffeine or placebo)Sponsors and contacts
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Source ClinicalTrials.gov