Olfactory Odour Stimulation for Metabolism Control

NCT04223284 | Completed

• 1 other identifier: 2019-01909;me19ChristCrain
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

D-limonene; lavender oil (SLVO); Olfactory stimulation; Obesity; glucose metabolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

• 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 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 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

Study Arms (2)

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

Other: D-Limonene; Other: SLVO

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

Other: D-Limonene; Other: SLVO

Interventions

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

Experimental1; Experimental2

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

Experimental1; Experimental2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years
• Obesity (BMI ≥35 kg/m2)
• Written informed consent
• Normosmia (defined by sniffin Sticks test)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

Limonene

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Monoterpenes; Terpenes

Study Officials

• Katharina Timper, Dr. med

  Endocrinology, Diabetology and Metabolism, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: December 10, 2019
• Primary Completion: May 10, 2022
• Study Completion: October 13, 2022
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

CH (1)