Overweight and Obesity
Conditions
Keywords
natural odour Inhalation, RCT, Placebo Controlled, Cerebrospinal Fluid
Brief summary
The goal of this clinical trial is to investigate the abundance of a natural odour in human cerebrospinal fluid in obese and lean participants after inhalation thereof. Participants will undergo blood sample collection and inhalation of either a natural odour or placebo through an inhaler in addition to a liquor puncture prescribed in standard of care context.
Interventions
COMBINATION_PRODUCTInhalation - Natural Odour
Inhalation of 50 uL of a natural odour via nasal septum mini-inhaler.
COMBINATION_PRODUCTInhalation - Placebo
Inhalation of 50 uL of Placebo via nasal septum mini-inhaler.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Obese Participants: * Age 18-60 years * Written informed consent * Scheduled for routine liquor puncture * BMI ≥ 30 kg/m2 * No proven diagnose of diabetes Inclusion Criteria Lean Participants: * Age 18-60 years * Written informed consent * Scheduled for routine liquor puncture * BMI 18-25 kg/m2
Exclusion criteria
* Known allergy to the natural odour * Acute upper respiratory tract infection, acute or chronic sinusitis * Present or past surgical intervention of the nasal cavity, the paranasal sinus, the pituitary or the frontal brain * Pregnancy/lactation * Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease, severe renal impairment with an estimated glomerular filtration rate \<30 ml/min/m2) * Inability to understand the study procedure and to sign the study consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of a natural odour in human CSF | 1 time assessment at baseline | Detection of a natural odour in human CSF within 30 min following end of an 15 min olfactory stimulation thereof compared to placebo. The presence of the Verum (natural odour) will be assessed via Gas Chromatography-Mass Spectrometry. This will be analyzed using a binary logistic regression model to determine the odds ratio of detecting a natural odour in the CSF post-stimulation. The model will account for variables such as age, sex, and BMI category (obese vs. lean). The significance level will be set at p \< 0.05. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abundance of a natural odour in human CSF of obese versus lean participants | 1 time assessment at baseline | Detection of a natural odour in human CSF of obese versus lean participants within 30 min following end of an 15 min olfactory stimulation with a natural odour. Titration of the natural odour will be done via Gas Chromatography-Mass Spectrometry. |
| Change in abundance of a natural odour in blood before and after olfactory stimulation in relation to abundance in human CSF. | 2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation) | Change in abundance of a natural odour in blood before and after end (max 30 min) of an olfactory stimulation for 15 min in relation to abundance in human CSF. Titration of the natural odour in CSF and blood samples will be done via Gas Chromatography-Mass Spectrometry. |
| Change in abundance of a natural odour in blood before and after olfactory stimulation in obese as compared to lean participants. | 2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation) | Change in abundance of a natural odour in blood before and after end (max 30 min) of an olfactory stimulation for 15 min in obese as compared to lean participants. Titration of a natural odour in blood samples will be done via Gas Chromatography-Mass Spectrometry. |
Countries
Switzerland
Contacts
CONTACTKatharina Timper, Prof. Dr. med.
CONTACTIsabel M Hofer
PRINCIPAL_INVESTIGATORKatharina Timper, Prof. Dr. med.
University Hospital Basel, Department of Endocrinology, Diabetology and Metabolism
Outcome results
None listed