Olfactory Odour Stimulation for Metabolism Control - the "OLFAMET-Study"

University Hospital, Basel, Switzerland1 site in 1 country41 target enrollmentDecember 10, 2019

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: University Hospital, Basel, Switzerland
Enrollment: 41
Locations: 1
Primary Endpoint: Change of area under blood glucose curve (AUBGC)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 10, 2019

End Date

October 13, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University Hospital, Basel, Switzerland

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change of area under blood glucose curve (AUBGC)

Time Frame: Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

area under the blood glucose curve (AUBGC) during a mixed-meal test after stimulation with D-Limonene compared to baseline

Secondary Outcomes

Change in plasma levels of glucagon-like peptide 1 (GLP-1)(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Change in plasma levels of Leptin(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Change in plasma Levels of Interleukin-6(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Change in plasma peak glucose levels(Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Change in plasma levels of lipids like LDL-cholesterine, total cholesterine, triglycerides(Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Visual Analogue Scale (VAS score)(Time Frame: baseline VAS score (timepoint 0) and VAS scores will be evaluated after 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Change in plasma insulin levels(Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Change in heart rate(Blood pressure and heart rate will be measured at the following times: baseline (timepoint 0) and 30, 60, 120 minutes drinking a standardized mixed-meal solution)
Change in blood pressure(Blood pressure and heart rate will be measured at the following times: baseline (timepoint 0) and 30, 60, 120 minutes drinking a standardized mixed-meal solution)
Change in plasma levels of gastric inhibitory polypeptide (GIP)(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Change in plasma levels of Peptide YY (PYY)(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Change in plasma Levels of C-reactive protein(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
AUBGC(Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Change in plasma levels of Ghrelin(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)
Change in plasma levels of Glucagon(Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution)