ABUNDANCE of A NATURAL ODOUR in HUMAN CEREBROSPINAL FLUID AFTER OLFACTORY EXPOSURE - the OLFO-Brain Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inhalation - Natural Odour, Inhalation - Placebo.
- Who it may be relevant to
- Registry conditions: Overweight and Obesity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure - the OLFO-Brain Study
Overview
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 product Inhalation - Natural Odour
Inhalation of 50 uL of a natural odour via nasal septum mini-inhaler. - Combination product Inhalation - Placebo
Inhalation of 50 uL of Placebo via nasal septum mini-inhaler.
Primary outcome measures
- Detection of a natural odour in human CSF [Time frame: 1 time assessment at baseline]
Secondary outcome measures (3)
- Abundance of a natural odour in human CSF of obese versus lean participants [Time frame: 1 time assessment at baseline]
- Change in abundance of a natural odour in blood before and after olfactory stimulation in relation to abundance in human CSF. [Time frame: 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 olfactory stimulation in obese as compared to lean participants. [Time frame: 2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Switzerland · 2 centers
- University Hospital Basel — Basel
- University Hospital of Basel — Basel
Publications
- 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. PMID 28592656
Identifiers
NCT: NCT06370845 · 0000-00000; kt24timper