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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum (natural odour) | Active Comparator | Participants will inhale 50 uL of a natural odour contained in mini-inhaler over a period of 15 min. |
|
| Placebo Inhalation | Placebo Comparator | Participants will inhale 50 uL of placebo (propylene glycol) contained in mini-inhaler over a period of 15 min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhalation - Natural Odour | Combination Product | Inhalation of 50 uL of a natural odour via nasal septum mini-inhaler. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria Obese Participants:
Inclusion Criteria Lean Participants:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katharina Timper, Prof. Dr. med. | Contact | 0041 61 328 57 42 | katharina.timper@usb.ch | |
| Isabel M Hofer | Contact | 0041 61 328 68 14 | Isabelmarie.hofer@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Katharina Timper, Prof. Dr. med. | University Hospital Basel, Department of Endocrinology, Diabetology and Metabolism | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Not yet recruiting | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28592656 | Background | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Inhalation - Placebo | Combination Product | Inhalation of 50 uL of Placebo via nasal septum mini-inhaler. |
|
| 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) |
| 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) |
| University Hospital of Basel | Recruiting | Basel | 4031 | Switzerland |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |