Clinical trial NCT06370845: Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure
Official title: Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure - the OLFO-Brain Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Overweight and Obesity
Keywords: natural odour Inhalation
RCT
Placebo Controlled
Cerebrospinal Fluid
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Detection of a natural odour in human CSF
timeFrame: 1 time assessment at baseline
Secondary outcomes:
measure: Abundance of a natural odour in human CSF of obese versus lean participants
timeFrame: 1 time assessment at baseline
measure: Change in abundance of a natural odour in blood before and after olfactory stimulation in relation to abundance in human CSF.
timeFrame: 2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation)
measure: Change in abundance of a natural odour in blood before and after olfactory stimulation in obese as compared to lean participants.
timeFrame: 2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital Basel, Department of Endocrinology, Diabetology and Metabolism
name: Katharina Timper, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Timper K, Bruning JC. Hypothalamic circuits regulating appetite and energy homeostasis: pathways to obesity. Dis Model Mech. 2017 Jun 1;10(6):679-689. doi: 10.1242/dmm.026609.