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ObesityOLFAMETNCT04223284

Olfactory Odour Stimulation for Metabolism Control

A study testing D-Limonene and SLVO in people with Obesity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this preliminary short-term study it is investigated, whether a short olfactory stimulation with D-Limonene leads to an acute improvement of glucose metabolism in patients with obesity. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obesity
What is being tested?
D-Limonene and SLVO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteSwitzerland
Study dates
10 Dec 2019to 13 Oct 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years
  • Obesity (BMI ≥35 kg/m2)
  • Written informed consent
  • Normosmia (defined by sniffin Sticks test)

Who cannot join

  • Known allergy to D-Limonene, citrus fruits, citrus flavours, SLVO
  • Regular smoking
  • Current illicit drug abuse including daily marijuana and cannabidiol (CBD) consumption (alcohol ≤2 drinks per day allowed)
  • Diabetes mellitus
  • Pre-Treatment with insulin sensitizing drugs including GLP-1 analogues
  • History of neurodegenerative diseases, severe head trauma
Show all 18Show fewer
  • Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2)
  • Known liver cirrhosis or other severe liver impairment
  • Acute upper respiratory tract infection
  • Uncontrolled dysthyroidism
  • Uncontrolled hypertension
  • Regular use of psychopharmaceutic drugs
  • Patient aims to start a new diet or exercise program during the study
  • Bariatric surgery
  • Pregnancy/Lactation
  • Symptoms of menopause
  • 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

  • Clinic for Intensive Care Medicine, University Hospital Basel

    Basel, 4031

Other trials in Switzerland

About this study

Official title: Olfactory Odour Stimulation for Metabolism Control - the "OLFAMET-Study"

In this preliminary short-term study it is investigated, whether a short olfactory stimulation with D-Limonene leads to an acute improvement of glucose metabolism in patients with obesity.

Conditions
Obesity
Being tested
D-Limonene, SLVO
Keywords
D-limonene, lavender oil (SLVO), Olfactory stimulation, Obesity, glucose metabolism
Medical subject headings
Obesity

What participants receive

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

  • D-LimoneneOther

    Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% D-Limonene in the nose for 15 minutes

  • SLVOOther

    Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% SLVO in the nose for 15 minutes

Study groups in NCT04223284
Study groupRoleWhat they receive
Experimental1Active comparatorDuring the Cross-Over study, patients will be randomly assigned to one of the arms: Treatment sequence: Placebo at the baseline visit, olfactory Stimulation with D-Limonene at visit 2 and olfactory Stimulation with lavender oil (SLVO) at visit 3
Receives: Other: D-Limonene; Other: SLVO
Experimental2Active comparatorDuring the Cross-Over study, patients will be randomly assigned to one of the arms: Treatment sequence: Placebo at the baseline visit, olfactory Stimulation with SLVO at visit 2 and olfactory Stimulation with D-Limonene at visit 3
Receives: Other: D-Limonene; Other: SLVO

What is being measured

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

  1. Change of area under blood glucose curve (AUBGC)

    area under the blood glucose curve (AUBGC) during a mixed-meal test after stimulation with D-Limonene compared to baseline

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

Secondary outcomes (15)

  1. AUBGC

    AUBGC during a mixed-meal test after stimulation with SLVO compared to baseline

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  2. Visual Analogue Scale (VAS score)

    VAS scores on hunger, appetite, nausea, mood, and hedonics of odour and/or taste of the mixed-meal shake, where 0 equals none, and 10 the maximum of each category

    Measured: Time Frame: baseline VAS score (timepoint 0) and VAS scores will be evaluated after 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  3. Change in plasma insulin levels

    Plasma insulin levels (mIU/L)

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  4. Change in plasma peak glucose levels

    Plasma peak glucose levels (mmol/L)

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  5. Change in plasma levels of glucagon-like peptide 1 (GLP-1)

    Plasma levels of GLP-1 (pmol/L)

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  6. Change in plasma levels of gastric inhibitory polypeptide (GIP)

    Plasma levels of GIP (pmol/L)

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  7. Change in plasma levels of Ghrelin

    Plasma levels of Ghrelin (pg/ml)

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  8. Change in plasma levels of Leptin

    Plasma levels of Leptin (ng/ml)

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  9. Change in plasma levels of Peptide YY (PYY)

    Plasma levels of PYY (pg/ml)

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  10. Change in plasma levels of Glucagon

    Plasma levels of Glucagon (pmol/L)

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  11. Change in plasma Levels of Interleukin-6

    Plasma Levels of Interleukin-6 (pg/ml)

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  12. Change in plasma Levels of C-reactive protein

    Plasma Levels of C-reactive protein (μg/ml)

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections after 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  13. Change in plasma levels of lipids like LDL-cholesterine, total cholesterine, triglycerides

    Plasma levels of lipids (mmol/L) like LDL-cholesterine, total cholesterine, triglycerides

    Measured: Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution

  14. Change in heart rate

    Heart rate (heart beats per minute)

    Measured: Blood pressure and heart rate will be measured at the following times: baseline (timepoint 0) and 30, 60, 120 minutes drinking a standardized mixed-meal solution

  15. Change in blood pressure

    blood pressure (mm Hg)

    Measured: Blood pressure and heart rate will be measured at the following times: baseline (timepoint 0) and 30, 60, 120 minutes drinking a standardized mixed-meal solution

Timeline

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

  1. First posted10 Jan 2020
  2. Study start10 Dec 2019
  3. Primary completion10 May 2022
  4. Study completion13 Oct 2022

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
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04223284
Sponsor's protocol ID
2019-01909;me19ChristCrain
Other IDs
2019
Acronym
OLFAMET
Status last verified
Nov 2023
First submitted
7 Jan 2020
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing D-Limonene and SLVO 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 18 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: finished, as of the sponsor's last update on 6 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of area under blood glucose curve (AUBGC) (time frame: Time Frame: baseline blood exam (timepoint 0) and further blood collections: 5, 15, 30, 60, 90 and 120 minutes after drinking a standardized mixed-meal solution). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04223284.

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 6 Dec 2023.

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Olfactory Odour Stimulation for Metabolism Control | AzTrials