Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure
- Conditions
- Overweight and Obesity
- Interventions
- Combination Product: Inhalation - Natural OdourCombination Product: Inhalation - Placebo
- Registration Number
- NCT06370845
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 32
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Verum (natural odour) Inhalation - Natural Odour Participants will inhale 50 uL of a natural odour contained in mini-inhaler over a period of 15 min. Placebo Inhalation Inhalation - Placebo Participants will inhale 50 uL of placebo (propylene glycol) contained in mini-inhaler over a period of 15 min.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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.
Trial Locations
- Locations (1)
University Hospital Basel
🇨đź‡Basel, Switzerland