Impact of Olfactory Odour StimulatioN on Energy EXpenditure

Obesity Clinical Trial

— SNEEX  

Official title:

SNEEX - Impact of Olfactory Odour StimulatioN on Energy EXpenditure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472168
• Other study ID #: Timper_Olfactory_2022
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: October 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Olfactory Stimulation
Participants are exposed to different odours and energy expenditure is assessed via indirect calorimetry.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Energy Expenditure	change in energy expenditure as assessed via calorimetry after olfactory stimulation with different odours.	6 hours
Secondary	Energy Expenditure, Additional Odours	Change in energy expenditure as assessed via calorimetry after olfactory stimulation with Different odours	6 hours
Secondary	Heart Rate	change in heart rate variability upon olfactory stimulation with different odors as assessed via continuous ECG	6 hours
Secondary	Blood Pressure	Change in blood pressure upon olfactory stimulation with different odors as assessed via a blood pressure cuff at the upper arm according to Riva Rocci	6 hours
Secondary	Metabolic Parameters	Change in metabolic blood parameters upon acute olfactory stimulation with different odours	6 hours
Secondary	Glucose Levels	change in interstitial fluid glucose levels upon olfactory stimulation with different odours	6 hours