ABUNDANCE of A NATURAL ODOUR in HUMAN CEREBROSPINAL FLUID AFTER OLFACTORY EXPOSURE - the OLFO-Brain Study
Recruiting · NCT06370845 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Basel, Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
Inhalation - Natural OdourInhalation - Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- bese 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
Where it is running
2 locations listed.
- University Hospital Basel - Basel, Switzerland
- University Hospital of Basel - Basel, Switzerland