Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure

Overweight and Obesity Clinical Trial

— OLFO-Brain  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370845
• Other study ID #: 0000-00000; kt24timper
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 1, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Katharina Timper, Prof. Dr. med.
• Phone: 0041 61 328 57 42
• Email: katharina.timper[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 puncture prescribed in standard of care context.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: October 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Combination Product:
• Inhalation - Natural Odour
Inhalation of 50 uL of a natural odour via nasal septum mini-inhaler.
• Inhalation - Placebo
Inhalation of 50 uL of Placebo via nasal septum mini-inhaler.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 time assessment at baseline
Secondary	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.	1 time assessment at baseline
Secondary	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.	2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation)
Secondary	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.	2 times assessment at baseline (immediately before olfactory stimulation and within 30 min following end of olfactory stimulation)