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

April 28, 2026 updated by: University Hospital, Basel, Switzerland

Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure - the OLFO-Brain Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Not yet recruiting
        • University Hospital Basel
        • Contact:
        • Contact:
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital of Basel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Verum (natural odour)
Participants will inhale 50 uL of a natural odour contained in mini-inhaler over a period of 15 min.
Combination product: Inhalation - Natural Odour
Inhalation of 50 uL of a natural odour via nasal septum mini-inhaler.
Placebo Comparator: Placebo Inhalation
Participants will inhale 50 uL of placebo (propylene glycol) contained in mini-inhaler over a period of 15 min.
Combination product: Inhalation - Placebo
Inhalation of 50 uL of Placebo via nasal septum mini-inhaler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of a natural odour in human CSF
Time Frame: 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.
1 time assessment at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abundance of a natural odour in human CSF of obese versus lean participants
Time Frame: 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.
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 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.
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)
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.
2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Katharina Timper, Prof. Dr. med., University Hospital Basel, Department of Endocrinology, Diabetology and Metabolism

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-00000; kt24timper

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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