Olfactory Odour Stimulation for Metabolism Control

University Hospital, Basel, Switzerland41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Obesity

Interventions

D-LimoneneOTHER

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

SLVOOTHER

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

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

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: 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 Outcomes

AUBGC

AUBGC during a mixed-meal test after stimulation with SLVO compared to baseline

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

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: 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

Plasma insulin levels (mIU/L)

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

Change in plasma peak glucose levels

Plasma peak glucose levels (mmol/L)

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

Change in plasma levels of glucagon-like peptide 1 (GLP-1)

Plasma levels of GLP-1 (pmol/L)

Data from ClinicalTrials.gov

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