Olfactory Odour Stimulation for Metabolism Control

Obesity Clinical Trial

— OLFAMET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223284
• Other study ID #: 2019-01909;me19ChristCrain
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: October 13, 2022

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 13, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• 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

Locations

Country	Name	City	State
Switzerland	Clinic for Intensive Care Medicine, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of area under blood glucose curve (AUBGC)	area under the blood glucose curve (AUBGC) during a mixed-meal test after stimulation with D-Limonene compared to baseline	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
Secondary	AUBGC	AUBGC during a mixed-meal test after stimulation with SLVO compared to baseline	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
Secondary	Visual Analogue Scale (VAS score)	VAS scores on hunger, appetite, nausea, mood, and hedonics of odour and/or taste of the mixed-meal shake, where 0 equals none, and 10 the maximum of each category	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
Secondary	Change in plasma insulin levels	Plasma insulin levels (mIU/L)	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
Secondary	Change in plasma peak glucose levels	Plasma peak glucose levels (mmol/L)	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
Secondary	Change in plasma levels of glucagon-like peptide 1 (GLP-1)	Plasma levels of GLP-1 (pmol/L)	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
Secondary	Change in plasma levels of gastric inhibitory polypeptide (GIP)	Plasma levels of GIP (pmol/L)	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
Secondary	Change in plasma levels of Ghrelin	Plasma levels of Ghrelin (pg/ml)	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
Secondary	Change in plasma levels of Leptin	Plasma levels of Leptin (ng/ml)	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
Secondary	Change in plasma levels of Peptide YY (PYY)	Plasma levels of PYY (pg/ml)	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
Secondary	Change in plasma levels of Glucagon	Plasma levels of Glucagon (pmol/L)	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
Secondary	Change in plasma Levels of Interleukin-6	Plasma Levels of Interleukin-6 (pg/ml)	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
Secondary	Change in plasma Levels of C-reactive protein	Plasma Levels of C-reactive protein (µg/ml)	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
Secondary	Change in plasma levels of lipids like LDL-cholesterine, total cholesterine, triglycerides	Plasma levels of lipids (mmol/L) 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
Secondary	Change in heart rate	Heart rate (heart beats per minute)	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
Secondary	Change in blood pressure	blood pressure (mm Hg)	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