Health TrialsbyHealthPanel

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

ConditionOverweight and Obesity
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age 18-60 years

Written informed consent

Scheduled for routine liquor puncture

BMI ≥ 30 kg/m2

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Verum (natural odour)Active comparator 1 intervention
Group B: Placebo InhalationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Detection of a natural odour in human CSF

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.

Time frame
1 time assessment at baseline

Secondary outcomes

1

Abundance of a natural odour in human CSF of obese versus lean participants

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.

Time frame
1 time assessment at baseline
2

Change in abundance of a natural odour in blood before and after olfactory stimulation in relation to abundance in human CSF.

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.

Time frame
2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation)
3

Change in abundance of a natural odour in blood before and after olfactory stimulation in obese as compared to lean participants.

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.

Time frame
2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Source ClinicalTrials.gov
Apply now