Olfactory Odour Stimulation for Metabolism Control
Not Applicable
Completed
- Conditions
- Obesity
- Interventions
- Other: D-LimoneneOther: SLVO
- Registration Number
- NCT04223284
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Experimental1 D-Limonene 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 Experimental2 D-Limonene 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 Experimental1 SLVO 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 Experimental2 SLVO 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
- Primary Outcome Measures
Name Time Method Change of area under blood glucose curve (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 area under the blood glucose curve (AUBGC) during a mixed-meal test after stimulation with D-Limonene compared to baseline
- Secondary Outcome Measures
Name Time Method 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 Plasma levels of GLP-1 (pmol/L)
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 Plasma levels of Leptin (ng/ml)
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 Plasma Levels of Interleukin-6 (pg/ml)
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 Plasma peak glucose levels (mmol/L)
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 Plasma levels of lipids (mmol/L) like LDL-cholesterine, total cholesterine, triglycerides
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 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
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 Plasma insulin levels (mIU/L)
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 Heart rate (heart beats per minute)
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 blood pressure (mm Hg)
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 Plasma levels of GIP (pmol/L)
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 Plasma levels of PYY (pg/ml)
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 Plasma Levels of C-reactive protein (μg/ml)
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 AUBGC during a mixed-meal test after stimulation with SLVO compared to baseline
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 Plasma levels of Ghrelin (pg/ml)
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 Plasma levels of Glucagon (pmol/L)
Trial Locations
- Locations (1)
Clinic for Intensive Care Medicine, University Hospital Basel
🇨🇭Basel, Switzerland