Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure (OLFO-Brain)

University Hospital Basel

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Overweight and Obesity

Treatments: Combination Product: Inhalation - Placebo; Combination Product: Inhalation - Natural Odour

Study type: Interventional

Funder types: Other

Identifiers

NCT06370845

0000-00000 kt24timper;

Details and patient eligibility

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups, including a placebo group

Verum (natural odour)

Active Comparator group

Description:

Participants will inhale 50 uL of a natural odour contained in mini-inhaler over a period of 15 min.

Treatment:

Combination Product: Inhalation - Natural Odour

Placebo Inhalation

Placebo Comparator group

Description:

Participants will inhale 50 uL of placebo (propylene glycol) contained in mini-inhaler over a period of 15 min.

Treatment:

Combination Product: Inhalation - Placebo