Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2019-12-10
2022-10-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Experimental1
During the Cross-Over study, patients will be randomly assigned to one of the arms:
Treatment sequence: Placebo at the baseline visit, olfactory Stimulation with D-Limonene at visit 2 and olfactory Stimulation with lavender oil (SLVO) at visit 3
D-Limonene
Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% D-Limonene in the nose for 15 minutes
SLVO
Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% SLVO in the nose for 15 minutes
Experimental2
During the Cross-Over study, patients will be randomly assigned to one of the arms:
Treatment sequence: Placebo at the baseline visit, olfactory Stimulation with SLVO at visit 2 and olfactory Stimulation with D-Limonene at visit 3
D-Limonene
Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% D-Limonene in the nose for 15 minutes
SLVO
Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% SLVO in the nose for 15 minutes
Interventions
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D-Limonene
Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% D-Limonene in the nose for 15 minutes
SLVO
Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% SLVO in the nose for 15 minutes
Eligibility Criteria
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Inclusion Criteria
* Obesity (BMI ≥35 kg/m2)
* Written informed consent
* Normosmia (defined by sniffin Sticks test)
Exclusion Criteria
* Regular smoking
* Current illicit drug abuse including daily marijuana and cannabidiol (CBD) consumption (alcohol ≤2 drinks per day allowed)
* Diabetes mellitus
* Pre-Treatment with insulin sensitizing drugs including GLP-1 analogues
* 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
* Acute upper respiratory tract infection
* Uncontrolled dysthyroidism
* Uncontrolled hypertension
* Regular use of psychopharmaceutic drugs
* Patient aims to start a new diet or exercise program during the study
* Bariatric surgery
* Pregnancy/Lactation
* Symptoms of menopause
* 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
18 Years
70 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Katharina Timper, Dr. med
Role: PRINCIPAL_INVESTIGATOR
Endocrinology, Diabetology and Metabolism, University Hospital Basel
Locations
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Clinic for Intensive Care Medicine, University Hospital Basel
Basel, , Switzerland
Countries
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Other Identifiers
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2019-01909;me19ChristCrain
Identifier Type: -
Identifier Source: org_study_id