Clinical trial

ABUNDANCE of A NATURAL ODOUR in HUMAN CEREBROSPINAL FLUID AFTER OLFACTORY EXPOSURE - the OLFO-Brain Study

Recruiting now · Early Phase 1 · 1 countries · Registry ID NCT06370845

Recruiting nowEarly Phase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight and Obesity

Full registry 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

Treatments and study arms

Inhalation - Natural Odour

Combination Product

Inhalation of 50 uL of a natural odour via nasal septum mini-inhaler.

Inhalation - Placebo

Combination Product

Inhalation of 50 uL of Placebo via nasal septum mini-inhaler.

Primary outcomes

Detection of a natural odour in human CSF1 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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

University Hospital Basel🇨🇭 Basel, Switzerland

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Katharina Timper, Prof. Dr. med.Contact

Email · Call 0041 61 328 57 42

Isabel M HoferContact

Email · Call 0041 61 328 68 14

University Hospital of Basel🇨🇭 Basel, Switzerland

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Lolita OdermattContact

Email · Call +41 61 328 55 20