- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07409025
Sensory Stimulation as a Driver of Diet-induced Thermogenesis (SENSATION)
SEnsory stimulatioN aS A Driver of dieT-induced Thermogenesis - the SENSATION Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Here, the investigators postulate sensory stimulation (i.e. the sight, smell, auditory and tactile properties, as well as the taste of food) to be drivers of diet induced thermogenesis, an insufficiently understood mechanism of body weight regulation. Research into this area to date has focused on macro-nutrient composition delivered unphysiologically (i.v. or in form of unpalatable solutions). Thereby neglecting the bulk of food-intake associated sensory stimulation and thus the contribution of the brain itself.
The investigators aim to gain insight into the role of sensory stimulation in this context by means of a cross-over proof-of concept exploratory clinical trial. Comparing 24 healthy human volunteers receiving a meal bolus with (orally) and without sensory stimulation (nasogastric-tube) by indirect calorimetry, tissue-adjacent temperature measurements and ex vivo analyses.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthias Betz, Prof.
- Phone Number: 0041 61 556 56 54
- Email: matthias.betz@usb.ch
Study Contact Backup
- Name: Sophia J Wiedemann, Dr. phil. Dr. med. M.Sc.
- Phone Number: 0041 61 328 44 97
- Email: sophiajulia.wiedemann@usb.ch
Study Locations
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-
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Basel, Switzerland, 4031
- Recruiting
- University Hospital Basel, Department of Endocrinology
-
Contact:
- Matthias Betz, Prof.
- Phone Number: 0041 61 556 56 54
- Email: matthias.betz@usb.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy volunteers of any gender
- BMI between 18-25 kg/m2
- age between 18 and 40 years
Exclusion Criteria:
- concomitant medication except for prescription free analgetics (paracetamol, NSAIDs) and oral contraceptives
- clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
- allergy to local anaesthetic or any of the study meal ingredients
- known or suspected non-compliance, drug or alcohol abuse
- smoker / habitual tobacco use
- habitual excessive alcohol consumption
- inability to follow the procedures of the study
- participation in another study with investigational drug within the 30 days preceding and during the present study
- previous enrolment into the current study
- enrolment of the investigator, his/her family members, employees and other dependent persons
- uncontrolled hypo- or hyperthyroidism
- pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sensory Exposure
Administration of a full meal orally
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Administration of a full meal orally ("regular eating") in study visit A
|
|
Experimental: Sensory Deprivation
Administration of the same meal as for the sensory exposure visit by way of a nasogastric tube
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Administration of a full meal via nasogastric tube in study visit B (thereby masking it from the senses)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet-induced energy expenditure
Time Frame: data will be collected from baseline (30 minutes before meal bolus administration) up to 300 minutes post-administration, divided into five segments: four 30-minute intervals and one 75-minute interval.
|
diet-induced thermogenesis as determined by indirect calorimetry measurements of VO2 in the sensory exposure condition (full meal) as compared to the sensory deprivation condition (same meal via nasogastric tube)
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data will be collected from baseline (30 minutes before meal bolus administration) up to 300 minutes post-administration, divided into five segments: four 30-minute intervals and one 75-minute interval.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin temperature
Time Frame: data will be collected from baseline (60 minutes before meal bolus administration) up to 300 minutes post-administration
|
brown adipose tissue activity as measured by supraclavicular skin temperature in response to both trial conditions It will be measured using wireless temperature sensors (iButton Thermochron) attached to the skin at 11 pre-defined locations
|
data will be collected from baseline (60 minutes before meal bolus administration) up to 300 minutes post-administration
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sophia J Wiedemann, Dr. phil. Dr. med. M.Sc., University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SENSATION_V3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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