Impact of Olfactory Odour StimulatioN on Energy EXpenditure

NCT ID: NCT05472168

Last Updated: 2023-12-20

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2024-10-30

Brief Summary

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In this preliminary short-term study it is investigated, whether a short olfactory stimulation with distinct odours impacts energy expenditure in patients with obesity and lean patients.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Obese

Age 18-55 years Obesity (BMI ≥30 kg/m2) Written informed consent Normosmia (defined by sniffing Sticks test)

Group Type OTHER

Olfactory Stimulation

Intervention Type OTHER

Participants are exposed to different odours and energy expenditure is assessed via indirect calorimetry.

Lean

Age 18-55 years Lean (BMI 18-25 kg/m2) Written informed consent Normosmia (defined by sniffing Sticks test)

Group Type OTHER

Olfactory Stimulation

Intervention Type OTHER

Participants are exposed to different odours and energy expenditure is assessed via indirect calorimetry.

Interventions

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Olfactory Stimulation

Participants are exposed to different odours and energy expenditure is assessed via indirect calorimetry.

Intervention Type OTHER

Other Intervention Names

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Different odours

Eligibility Criteria

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Inclusion Criteria

* • Age 18-55 years

* Obesity (BMI ≥30 kg/m2) and Lean (BMI 18-25 kg/m2)
* Written informed consent
* Normosmia (defined by sniffing Sticks test)

Exclusion Criteria

* • Chronic or acute sinusitis

* Surgical intervention of the nasal cavity or the paranasal sinus
* Known allergy to odors used in the study
* Smokers
* Current illicit drug abuse including daily marijuana and cannabidiol (CBD) consumption (alcohol ≤2 drinks per day allowed)
* Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
* Diabetes mellitus
* Treatment with insulin sensitizing drugs including Glucagon-like Peptide (GLP)-1 analogues within the last 3 months
* 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
* Use of any kind of decongestant more than twice a week
* Use of cortisone-containing nasal spray within the last 3 months
* Acute upper respiratory tract infection
* Uncontrolled dysthyroidism
* Uncontrolled hypertension
* Regular use of psychopharmaceutic drugs
* Study participants aims to start a new diet or exercise program during the study
* Bariatric surgery
* Pregnancy/Lactation
* Onset of climacteric symptoms within one year (e.g. hot flashes and/or diaphoresis) OR initiation of hormonal replacement therapy in the last three months
* 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

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Katharina Timper

Principal Investigator, Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Katharina Timper, Prof.Dr.med.

Role: primary

Anouk Hoogkamer

Role: backup

Other Identifiers

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Timper_Olfactory_2022

Identifier Type: -

Identifier Source: org_study_id