Impact of Olfactory Odour StimulatioN on Energy EXpenditure (SNEEX)

SNEEX - Impact of Olfactory Odour StimulatioN on Energy EXpenditure

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Olfactory Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • Recruiting
    • University Hospital Basel
    • Principal Investigator: Katharina Timper, Prof.Dr.med.
    • Contact: Anouk Hoogkamer; Phone Number: +41 61 328 55 20; Email: anouklisa.hoogkamer@usb.ch
    • Contact: Katharina Timper, Prof.Dr.med.; Phone Number: +41 61 328 57 42; Email: katharina.timper@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Obese; Age 18-55 years Obesity (BMI ≥30 kg/m2) Written informed consent Normosmia (defined by sniffing Sticks test)	Other: Olfactory Stimulation; Participants are exposed to different odours and energy expenditure is assessed via indirect calorimetry.; Other Names: Different odours
Other: Lean; Age 18-55 years Lean (BMI 18-25 kg/m2) Written informed consent Normosmia (defined by sniffing Sticks test)	Other: Olfactory Stimulation; Participants are exposed to different odours and energy expenditure is assessed via indirect calorimetry.; Other Names: Different odours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Energy Expenditure	change in energy expenditure as assessed via calorimetry after olfactory stimulation with different odours.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy Expenditure, Additional Odours	Change in energy expenditure as assessed via calorimetry after olfactory stimulation with Different odours	6 hours
Heart Rate	change in heart rate variability upon olfactory stimulation with different odors as assessed via continuous ECG	6 hours
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
Glucose Levels	change in interstitial fluid glucose levels upon olfactory stimulation with different odours	6 hours
Metabolic Parameters	Change in metabolic blood parameters upon acute olfactory stimulation with different odours	6 hours

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Timper_Olfactory_2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No