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

NCT07498062 | Completed

• 1 other identifier: FMHS 224-0624
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anosmia; Parosmia; Phantosmia; Dysgeusia; Ageusia

Keywords

Multimodal flavour perception; flavour training; chewing gum; flavour perception recovery

Outcome Measures

Primary Outcomes (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.

  From enrolment to study to after 12 weeks.

Secondary Outcomes (6)

• Identification of taste using four basic taste solutions

  From enrolment to study to after 12 weeks.

• At home smell test

  From enrolment to study to after 12 weeks.

• Training compliance

  From enrolment to study to after 12 weeks.

• Reflection on training and feasibility of the study.

  From enrolment to study to after 12 weeks.

• Reflection on severity of abnormality in flavour perception

  From enrolment to study to after 12 weeks.

Study Arms (3)

Waiting list control group

OTHER

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

Other: Waiting list control group

Flavour impairment training using chewing gum group (FIT)

EXPERIMENTAL

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

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

Olfactory training group (OT)

ACTIVE COMPARATOR

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

Other: Olfactory training group (OT)

Interventions

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.

Flavour impairment training using chewing gum group (FIT)

Olfactory training group (OT) OTHER

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

Olfactory training group (OT)

Waiting list control group OTHER

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

Waiting list control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nottingham: lead
• TasteTech: collaborator

Study Sites (1)

University of Nottingham

Loughborough, Leicestershire, LE12 5RD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35926120 BACKGROUND

MeSH Terms

Conditions

Anosmia; Olfaction Disorders; Dysgeusia; Ageusia

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Taste Disorders

Study Officials

• Ni Yang, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Rebecca Ford, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Moira A Taylor, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: October 21, 2024
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: April 2025- indefinitely
• Access Criteria: Information will be available on request.

Locations

GB (1)