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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental1 | Active Comparator | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-Limonene | Other | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Visual Analogue Scale (VAS score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katharina Timper, Dr. med | Endocrinology, Diabetology and Metabolism, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Intensive Care Medicine, University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077222 | Limonene |
| ID | Term |
|---|---|
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| SLVO | Other | 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 |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D039821 | Monoterpenes |
| D013729 | Terpenes |