Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT05472168
Eligibility Criteria:
Inclusion Criteria:
* • Age 18-55 years
* Obesity (BMI ≥30 kg/m2) and Lean (BMI 18-25 kg/m2)
* Written informed consent
* Normosmia (defined by sniffing Sticks test)
Exclusion Criteria:
* • Chronic or acute sinusitis
* Surgical intervention of the nasal cavity or the paranasal sinus
* Known allergy to odors used in the study
* Smokers
* Current illicit drug abuse including daily marijuana and cannabidiol (CBD) consumption (alcohol ≤2 drinks per day allowed)
* Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
* Diabetes mellitus
* Treatment with insulin sensitizing drugs including Glucagon-like Peptide (GLP)-1 analogues within the last 3 months
* History of neurodegenerative diseases, severe head trauma
* Severe renal impairment (e.g. estimated glomerular filtration rate \<30 ml/min/m2)
* Known liver cirrhosis or other severe liver impairment
* Use of any kind of decongestant more than twice a week
* Use of cortisone-containing nasal spray within the last 3 months
* Acute upper respiratory tract infection
* Uncontrolled dysthyroidism
* Uncontrolled hypertension
* Regular use of psychopharmaceutic drugs
* Study participants aims to start a new diet or exercise program during the study
* Bariatric surgery
* Pregnancy/Lactation
* Onset of climacteric symptoms within one year (e.g. hot flashes and/or diaphoresis) OR initiation of hormonal replacement therapy in the last three months
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Participation in an interventional study within the last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05472168
Study Brief:
Protocol Section:
NCT05472168