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ObesitySNEEXNCT05472168

Impact of Olfactory Odour StimulatioN on Energy EXpenditure

A study testing Olfactory Stimulation in people with Obesity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Olfactory Stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteSwitzerland
Study dates
18 Jan 2022to 30 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • 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)

Who cannot join

  • • 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)
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site, 1 recruiting
  • University Hospital Basel

    Basel

    Katharina Timper, Prof.Dr.med., +41 61 328 57 42, katharina.timper@usb.ch

    Anouk Hoogkamer, +41 61 328 55 20, anouklisa.hoogkamer@usb.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

Conditions
Obesity
Being tested
Olfactory Stimulation
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olfactory StimulationOther

    Also called Different odours

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

Study groups in NCT05472168
Study groupRoleWhat they receive
ObeseOtherAge 18-55 years Obesity (BMI ≥30 kg/m2) Written informed consent Normosmia (defined by sniffing Sticks test)
Receives: Other: Olfactory Stimulation
LeanOtherAge 18-55 years Lean (BMI 18-25 kg/m2) Written informed consent Normosmia (defined by sniffing Sticks test)
Receives: Other: Olfactory Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Energy Expenditure

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

    Measured: 6 hours

Secondary outcomes (5)
  1. Energy Expenditure, Additional Odours

    Change in energy expenditure as assessed via calorimetry after olfactory stimulation with Different odours

    Measured: 6 hours

  2. Heart Rate

    change in heart rate variability upon olfactory stimulation with different odors as assessed via continuous ECG

    Measured: 6 hours

  3. 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

    Measured: 6 hours

  4. Metabolic Parameters

    Change in metabolic blood parameters upon acute olfactory stimulation with different odours

    Measured: 6 hours

  5. Glucose Levels

    change in interstitial fluid glucose levels upon olfactory stimulation with different odours

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start18 Jan 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05472168
Sponsor's protocol ID
Timper_Olfactory_2022
Acronym
SNEEX
Status last verified
Dec 2023
First submitted
21 Jul 2022
Last updated
20 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Olfactory Stimulation in people with Obesity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Energy Expenditure (time frame: 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.

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