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Olfactory Odour Stimulation for Metabolism Control (OLFAMET)

Primary Purpose

Obesity

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

D-Limonene

SLVO

About this trial

This is an interventional other trial for Obesity focused on measuring D-limonene, lavender oil (SLVO), Olfactory stimulation, Obesity, glucose metabolism

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinic for Intensive Care Medicine, University Hospital BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Experimental1

Experimental2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

AUBGC

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

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

Change in plasma insulin levels

Plasma insulin levels (mIU/L)

Change in plasma peak glucose levels

Plasma peak glucose levels (mmol/L)

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

Plasma levels of GLP-1 (pmol/L)

Change in plasma levels of gastric inhibitory polypeptide (GIP)

Plasma levels of GIP (pmol/L)

Change in plasma levels of Ghrelin

Plasma levels of Ghrelin (pg/ml)

Change in plasma levels of Leptin

Plasma levels of Leptin (ng/ml)

Change in plasma levels of Peptide YY (PYY)

Plasma levels of PYY (pg/ml)

Change in plasma levels of Glucagon

Plasma levels of Glucagon (pmol/L)

Change in plasma Levels of Interleukin-6

Plasma Levels of Interleukin-6 (pg/ml)

Change in plasma Levels of C-reactive protein

Plasma Levels of C-reactive protein (μg/ml)

Change in plasma levels of lipids like LDL-cholesterine, total cholesterine, triglycerides

Plasma levels of lipids (mmol/L) like LDL-cholesterine, total cholesterine, triglycerides

Change in heart rate

Heart rate (heart beats per minute)

Change in blood pressure

blood pressure (mm Hg)

Full Information

NCT ID

NCT04223284

First Posted

January 7, 2020

Last Updated

April 19, 2022

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT04223284

Brief Title

Olfactory Odour Stimulation for Metabolism Control

Acronym

OLFAMET

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 10, 2019 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental1

Arm Type

Active Comparator

Arm Description

Arm Title

Experimental2

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

D-Limonene

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

SLVO

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of area under blood glucose curve (AUBGC)

Description

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 Outcome Measure Information:

Title

AUBGC

Description

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

Title

Visual Analogue Scale (VAS score)

Description

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

Title

Change in plasma insulin levels

Description

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

Title

Change in plasma peak glucose levels

Description

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

Title

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

Description

Plasma levels of GLP-1 (pmol/L)

Time Frame