Olfactory Odour Stimulation for Metabolism Control

NCT ID: NCT04223284

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2022-10-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental1

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

Group Type ACTIVE_COMPARATOR

D-Limonene

Intervention Type 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

SLVO

Intervention Type 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

Experimental2

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

Group Type ACTIVE_COMPARATOR

D-Limonene

Intervention Type 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

SLVO

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

D-Limonene

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

SLVO

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katharina Timper, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Endocrinology, Diabetology and Metabolism, University Hospital Basel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-01909;me19ChristCrain

Identifier Type: -

Identifier Source: org_study_id