Olfactory Odour Stimulation for Metabolism Control (OLFAMET)

University Hospital Basel

Status: Completed

Conditions: Obesity

Treatments: Other: D-Limonene; Other: SLVO

Study type: Interventional

Funder types: Other

Identifiers

NCT04223284

2019-01909 me19ChristCrain;

Details and patient eligibility

About

In this preliminary short-term study it is investigated, whether a short olfactory stimulation with D-Limonene leads to an acute improvement of glucose metabolism in patients with obesity.

Enrollment: 41 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-70 years
• Obesity (BMI ≥35 kg/m2)
• Written informed consent
• Normosmia (defined by sniffin Sticks test)

Exclusion criteria

• Known allergy to D-Limonene, citrus fruits, citrus flavours, SLVO
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Experimental1

Active Comparator group

Description:

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

Treatment:

Other: SLVO

Other: D-Limonene

Experimental2

Active Comparator group

Description:

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

Treatment:

Other: SLVO

Other: D-Limonene