NCT05472168

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

2.4 years

First QC Date

July 21, 2022

Last Update Submit

December 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Energy Expenditure

    change in energy expenditure as assessed via calorimetry after olfactory stimulation with different odours.

    6 hours

Secondary Outcomes (5)

  • Energy Expenditure, Additional Odours

    6 hours

  • Heart Rate

    6 hours

  • Blood Pressure

    6 hours

  • Metabolic Parameters

    6 hours

  • Glucose Levels

    6 hours

Study Arms (2)

Obese

OTHER

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

Other: Olfactory Stimulation

Lean

OTHER

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

Other: Olfactory Stimulation

Interventions

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

Also known as: Different odours
LeanObese

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Switzerland

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Prof. Dr. med.

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

January 18, 2022

Primary Completion

June 30, 2024

Study Completion

October 30, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations