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AnosmiaFITSNCT07498062

Multimodal Chewing Gum Flavour Training to Aid Flavour Perception Recovery - a Pilot Study.

A study testing Flavour impairment training using chewing gum group (FIT) and Olfactory training group (OT) in people with Anosmia and Parosmia, run by University of Nottingham at 1 site in United Kingdom.

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

Olfactory training is developed for people who have partly or completely lost their sense of smell (olfactory dysfunction). Participants expose themselves to odours twice daily for usually 12 weeks or longer. It has been proven to effectively help people improve their sense of smell. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Anosmia, Parosmia, Phantosmia
What is being tested?
Flavour impairment training using chewing gum group (FIT) and Olfactory training group (OT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
21 Oct 2024to 19 Mar 2026
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Aged between 18 and 65 years male and female
  • Have impairment in smell and/or taste (with a medical diagnosis or self-perception of between 3 months and 2 years)
  • Were able to smell and taste normally prior to the impairment (we anticipate that participants will have experienced the condition following a viral infection or idiopathically, etc)
  • Voluntary participation in the study
  • Willing to travel to Nottingham for 2 lab visits
  • Able to give informed written consent
  • Having not taken part in olfactory training or related research in the last 3 months or any study providing an inconvenience allowance.

Who cannot join

  • • Physical damage in oral and/or nasal cavity due to surgery, trauma, etc.
  • Active infection with a virus that impedes smell and/or taste perception, sinonasal diseases, Parkinson's disease
  • Chewing or biting difficulty that would restrict chewing gum regularly
  • Allergy to chewing gum ingredients
  • Pregnancy or lactating
  • Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (this must remain for ALL UoN FMHS UREC approved studies)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Nottingham

    Loughborough, Leicestershire, LE12 5RD

Other trials in United Kingdom

About this study

Official title: Developing a Multimodal Flavour Training Using Chewing Gum to Aid Flavour Perception Recovery - a Pilot Study

Olfactory training is developed for people who have partly or completely lost their sense of smell (olfactory dysfunction). Participants expose themselves to odours twice daily for usually 12 weeks or longer. It has been proven to effectively help people improve their sense of smell. However, when abnormal flavour perception is reported it may involve not only a dysfunctional sense of smell, but also taste and trigeminal perception (e.g. burning from chilly, cooling from mint, etc.). The stimulation of multiple sensations can theoretically enhance overall flavour perception. Therefore, we propose a pilot study to test the feasibility testing multi-sensation flavour impairment training approach using chewing gum that target sensations of smell, taste and trigeminal. This will be in comparison with an existing olfactory training approach.

Individuals (aged 18 to 65) with changed flavour perception (self-perceived, within 3 months to 2 years) will be invited to take part in this study. Participants will be randomly and evenly allocated to 3 groups which are: flavour impairment training using chewing gum (FIT), olfactory training (OT) using smelling strips, and a waiting list control group (CTR) (delaying FIT training for 12 weeks). In the first two groups, a 12-week training will be conducted. The training will be undertaken twice a day (in the morning and evening). All participants will use four flavours in a pre-determined and randomised order. One flavour of chewing gum (FIT group) or smelling strips (OT group) will be used each time. Each training session is expected to last around 3 minutes. In addition to the training, all participants will be asked to pay two visits to the lab, once before and once after completing the 12-week training, or the 12-week wait, to evaluate their flavour (smell, taste and trigeminal) perception capability. Participants will also be asked to conduct flavour perception tests at home before and after training following instructions to evaluate if their flavour perception capability has improved due to the training. The OT group and the CTR group will be offered the FIT treatment after they have undertaken the 12 weeks of their study group allocation.

Read the detailed description

Eligibility will be checked via an online questionnaire, where information of flavour perception impairment (self-report), chewing gum consumption habit, potential allergy to chewing gum/smelling bottle ingredients, and difficulty in chewing gums will be checked according to the inclusion and exclusion criteria .

Eligible participants will then be contacted via email for session time confirmation and taking consent. Upon their first visit to the lab, written consent will be taken, and training kit will be given to them.

Participants will be asked to pay two visits to the lab - to evaluate their smell perception using Sniffin' Sticks following a standard protocol (Rumeau et al., 2016) and taste perception using filter-paper disc (Nishijima et al., 2013). Upon their first lab visit, they will taste the four flavours (1 tablet per flavour) of the chewing gum that will be used in the following training. They will be given a questionnaire to indicate their perception and liking of all flavours. If there is any flavour, they find particularly disturbing that they do not wish to use to conduct the training, they have the opportunity to withdraw. Please see Fig.2. participant activities for lab visits and training at home. For both lab visits, participants will be given aromatic sticks to sniff to evaluate their Threshold, Discrimination and Identification (TDI score) of olfactory functions. Participants will also be given filter-paper discs of four tastes of sweet (sucrose), salty (sodium chloride), sour (citric acid) and bitter (quinine), and two trigeminal of cooling (menthol) and hot/burning (capsaicin) to evaluate their identification capability and threshold of taste and trigeminal sensations. Each session is expected to take up to 2 hours. On their first lab visit, participants will also be given logging-in information (by participant number) to an Xerte webpage so that they can access training protocol and their flavour selection if needed. Subsequently to the two lab visits, participants will be asked to conduct two at-home tests (once before and once after the 12-week training/waiting) to evaluate their smell, taste and trigeminal perception. For both OT and CTR groups, participants will be offered chewing gum training kit on their second lab visit.

Being tested
Flavour impairment training using chewing gum group (FIT), Olfactory training group (OT), Waiting list control group
Keywords
Multimodal flavour perception, flavour training, chewing gum, flavour perception recovery
Medical subject headings
Anosmia, Olfaction Disorders, Dysgeusia, Ageusia

What participants receive

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

  • Flavour impairment training using chewing gum group (FIT)Other

    Participants are randomly allocated to chew gum twice a day for 12 weeks whilst at home.

  • Olfactory training group (OT)Other

    Participants are randomly allocated to smell liquid flavouring twice a day for 12 weeks whilst at home.

  • Waiting list control groupOther

    Participants are randomly allocated once baseline data has been collected to a waiting list control group where no action will be taken.

Study groups in NCT07498062
Study groupRoleWhat they receive
Waiting list control groupOtherParticipants are randomly allocated once baseline data has been collected to a waiting list control group where no action will be taken.
Receives: Other: Waiting list control group
Flavour impairment training using chewing gum group (FIT)ExperimentalParticipants are randomly allocated to chew gum twice a day for 12 weeks whilst at home.
Receives: Other: Flavour impairment training using chewing gum group (FIT)
Olfactory training group (OT)Active comparatorParticipants are randomly allocated to smell liquid flavouring twice a day for 12 weeks whilst at home.
Receives: Other: Olfactory training group (OT)

What is being measured

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

  1. Overall Threshold Discrimination and Identification (TDI) score using Sniffin' Sticks.

    Participants will be required to sniff aromatic pens to evaluate their Threshold Discrimination and Identification of aromas at the at start and end of the study.

    Measured: From enrolment to study to after 12 weeks.

Secondary outcomes (6)
  1. Identification of taste using four basic taste solutions

    Participants are required to identify whether they can taste four different basic tastes at the start and end of the study.

    Measured: From enrolment to study to after 12 weeks.

  2. At home smell test

    Participants, whilst blindfolded, will be required to attempt to identify 5 smells commonly found in the home.

    Measured: From enrolment to study to after 12 weeks.

  3. Training compliance

    Participants will be required to submit weekly completion questionnaires online for 12 weeks.

    Measured: From enrolment to study to after 12 weeks.

  4. Reflection on training and feasibility of the study.

    Participants will be required to complete a questionnaire exploring their perceptions of the feasibility of the study.

    Measured: From enrolment to study to after 12 weeks.

  5. Reflection on severity of abnormality in flavour perception

    Participants will be required to complete a questionnaire recording their perception of the severity of their abnormality in flavour perception

    Measured: From enrolment to study to after 12 weeks.

  6. Perception of impact on life experience of changes in flavour perception.

    Participants will be required to complete a questionnaire exploring the impact of their flavour perception on their life experience.

    Measured: From enrolment to study to after 12 weeks.

Timeline

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

  1. First posted27 Mar 2026
  2. Study start21 Oct 2024
  3. Primary completion19 Mar 2026
  4. Study completion19 Mar 2026

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498062
Sponsor's protocol ID
FMHS 224-0624
Acronym
FITS
Status last verified
Mar 2026
First submitted
23 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All aspects

Publications

  • Li Z, Stolper S, Draf J, Haehner A, Hummel T. Smell, taste and trigeminal function: similarities and differences between results from home tests and examinations in the clinic. Rhinology. 2022 Aug 1;60(4):293-300. doi: 10.4193/Rhin21.430.

    PubMed 35926120

Questions about this trial

What is this clinical trial studying?

A study testing Flavour impairment training using chewing gum group (FIT) and Olfactory training group (OT) in people with Anosmia and Parosmia, run by University of Nottingham at 1 site in United Kingdom.

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 7 inclusion and 6 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 27 Mar 2026. 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 United Kingdom. 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?

Overall Threshold Discrimination and Identification (TDI) score using Sniffin' Sticks. (time frame: From enrolment to study to after 12 weeks.). 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 NCT07498062, which also lists 1 linked publication.

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 27 Mar 2026.

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