Overweight and ObesityEarly Phase 1OLFO-BrainNCT06370845
ABUNDANCE of A NATURAL ODOUR in HUMAN CEREBROSPINAL FLUID AFTER OLFACTORY EXPOSURE - the OLFO-Brain Study
A Early Phase 1 study testing Inhalation - Natural Odour in people with Overweight and Obesity, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Inhalation - Natural Odour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 14 Apr 2026to 30 Oct 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years
- Written informed consent
- Scheduled for routine liquor puncture
- BMI ≥ 30 kg/m2
- No proven diagnose of diabetes
- Age 18-60 years
Show all 9Show fewer
- Written informed consent
- Scheduled for routine liquor puncture
- BMI 18-25 kg/m2
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Not yet recruiting
University Hospital Basel
Basel, 4031
Katharina Timper, Prof. Dr. med., 0041 61 328 57 42, katharina.timper@usb.ch
Isabel M Hofer, 0041 61 328 68 14, isabelmarie.hofer@usb.ch
- Recruiting
University Hospital of Basel
Basel, 4031
Lolita Odermatt, +41 61 328 55 20, lolita.odermatt@usb.ch
About this study
Official title: 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.
- Conditions
- Overweight and Obesity
- Being tested
- Inhalation - Natural Odour, Inhalation - Placebo
- Keywords
- natural odour Inhalation, RCT, Placebo Controlled, Cerebrospinal Fluid
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation - Natural OdourCombination product
Inhalation of 50 uL of a natural odour via nasal septum mini-inhaler.
Inhalation - PlaceboCombination product
Inhalation of 50 uL of Placebo via nasal septum mini-inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Verum (natural odour) | Active comparator | Participants will inhale 50 uL of a natural odour contained in mini-inhaler over a period of 15 min. Receives: Combination Product: Inhalation - Natural Odour |
| Placebo Inhalation | Placebo comparator | Participants will inhale 50 uL of placebo (propylene glycol) contained in mini-inhaler over a period of 15 min. Receives: Combination Product: Inhalation - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 time assessment at baseline
Secondary outcomes (3)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start14 Apr 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katharina Timper, Prof. Dr. med., Principal investigator, University Hospital Basel, Department of Endocrinology, Diabetology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370845
- Sponsor's protocol ID
- 0000-00000; kt24timper
- Acronym
- OLFO-Brain
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28592656
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure - the OLFO-Brain Study
- ClinicalTrials.gov ID
- NCT06370845
- Acronym / sponsor ID
- OLFO-Brain / 0000-00000; kt24timper
- Conditions
- Overweight and Obesity
- Keywords
- natural odour Inhalation, RCT, Placebo Controlled, Cerebrospinal Fluid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum (natural odour) | Active comparator | Combination Product: Inhalation - Natural OdourParticipants will inhale 50 uL of a natural odour contained in mini-inhaler over a period of 15 min. |
| Placebo Inhalation | Placebo comparator | Combination Product: Inhalation - PlaceboParticipants will inhale 50 uL of placebo (propylene glycol) contained in mini-inhaler over a period of 15 min. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-60 years
- Written informed consent
- Scheduled for routine liquor puncture
- BMI ≥ 30 kg/m2
- No proven diagnose of diabetes
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation - Natural OdourInhalation of 50 uL of a natural odour via nasal septum mini-inhaler. | Combination product | Verum (natural odour) |
| Inhalation - PlaceboInhalation of 50 uL of Placebo via nasal septum mini-inhaler. | Combination product | Placebo Inhalation |
Primary outcome
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 28592656Timper 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katharina Timper, Prof. Dr. med. principal investigator
University Hospital Basel, Department of Endocrinology, Diabetology and Metabolism
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Inhalation - Natural Odour in people with Overweight and Obesity, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharina Timper, Prof. Dr. med. (0041 61 328 57 42, katharina.timper@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of a natural odour in human CSF (time frame: 1 time assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06370845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.