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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06370845
Other study ID # 0000-00000; kt24timper
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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