Impact of Olfactory Odour StimulatioN on Energy EXpenditure

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Other: Olfactory Stimulation

• Registration Number: NCT05472168
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-06-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lean	Olfactory Stimulation	Age 18-55 years Lean (BMI 18-25 kg/m2) Written informed consent Normosmia (defined by sniffing Sticks test)
Obese	Olfactory Stimulation	Age 18-55 years Obesity (BMI ≥30 kg/m2) Written informed consent Normosmia (defined by sniffing Sticks test)

Primary Outcome Measures

Name	Time	Method
Change in Energy Expenditure	6 hours	change in energy expenditure as assessed via calorimetry after olfactory stimulation with different odours.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland