Cognitive ChangeNCT05544500
Immediate and Residual Effects of Functional Chewing Gum on Concentration
A study testing Functional Gum and Basic Chewing Gum in people with Cognitive Change, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Previous research suggests that chewing gum may influence several functions including attention and alertness. Gum can also be used as a vehicle for delivering ingredients that have the ability to modulate attention and mood. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Functional Gum and Basic Chewing Gum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jul 2022to 15 Sep 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must self-assess themselves as being in good health
- Aged 18 to 35 years at the time of giving consent
- Report good oral health and chewing ability
- Proficient in English
Who cannot join
- Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: There may be unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance.
- Are currently taking prescription medications NOTE: the explicit exception to this are contraceptive treatments for female participants, topical skin treatments e.g. for eczema, acne, and those taken 'as needed' in the treatment of hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening. Use of any medications which impact mood or cognitive function e.g. anti depressants, anti anxiety medications etc. are not permitted.
- Have undergone dental treatment 1 week before the test, or needs or is planning dental treatments during the study (excluding routine dental check-up)
- Have a Body Mass Index (BMI) outside of the range 18.5-30 kg/m2
- Are pregnant, seeking to become pregnant or lactating.
- Have a visual impairment that cannot be corrected with glasses or contact lenses (excluding colour-blindness)
Show all 11Show fewer
- Smoke tobacco or vape nicotine or use nicotine replacement products (occasional social smoking is permitted)
- Have relevant food intolerances/ sensitivities/ allergies
- Have taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement washout prior to participating and for the duration of the study on the proviso that the supplements are taken are out of choice and are not medically prescribed or advised). Existing and consistent use of vitamin D supplements and protein shakes are permitted
- Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
- Are unable to complete all of the study assessments
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Psychology, Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Previous research suggests that chewing gum may influence several functions including attention and alertness. Gum can also be used as a vehicle for delivering ingredients that have the ability to modulate attention and mood. This study will explore the effects of a functional gum containing a proprietary composition of a herbal extract and vitamins. These effects will be compared to the effects of a basic sugar-free gum and to a tablet which will include the same ingredients as the basic sugar-free gum. Effects will be explored on computerised measures of attention/concentration and via ratings of current mood. The study will assess the immediate effects of chewing gum as well as the effects 1 hour later.
There will be an initial remote screening session followed by visits to the laboratory on 4 separate occasions: an introductory/training visit and three active study days.
Read the detailed description
This randomised, double-blind, placebo-controlled, counterbalanced crossover study will assess the acute effects of chewing functional gum on measures of concentration and mental acuity in healthy participants in comparison to basic sugar free gum and placebo.
The trial will utilise the COMPASS cognitive assessment system and a series of subjective mood measures. The core cognitive assessment of study will employ a selection of tasks assessing performance within the 'Psychomotor Speed', 'Sustained Attention', and 'Decision Making' cognitive domains. Subjective changes in mood ('alertness', 'stress', 'tranquillity', concentration', 'focus' and 'mental tiredness') will also be assessed.
Assessments will take place at baseline, during treatment consumption and 1 hour post-dose to assess the residual effects following chewing.
Participants will have an initial remote screening session followed by visits to the laboratory on 4 separate occasions: an introductory/training visit (Day 0) and three active study days (Day 1, Day 2, and Day 3) spaced 2 days apart (+5 days).
The remote screening session will be completed via telephone call and will comprise: briefing on requirements of the study, obtaining of informed consent via completion of an online consent form, health screening, collection of demographic data, and completion of the Caffeine Consumption Questionnaire (CCQ).
The introductory/training visit to the laboratory will begin with physiological eligibility measures that cannot be completed remotely (e.g. height and weight, waist-to-hip ratio) followed by training on the cognitive and mood measures.
Following the introductory visit participants will attend the laboratory at either 10 am or 2 pm on three separate occasions (Day 1, Day 2, and Day 3) with testing time consistent within participants and counterbalanced across treatment orders. All testing days (will be identical, with the exception that the participants will consume a different treatment at each visit.
On each testing visit participants will be required to eat a standard meal at least 1 hour before testing and to abstain from alcohol and over the counter medications (including hay fever medications) for 24 hours and caffeinated products for 5 hours before testing (meal items should be kept consistent across visits). Participants will arrive to the laboratory at their allotted time and, following completion of the Case Report Form (to confirm continued compliance with inclusion/exclusion criteria), complete a baseline assessment for that day (10 mins). They will then be randomised to treatment order (Day 1 only). Participants will have a 10-minute rest before completing the tasks again whilst 'chewing' their allotted treatment for that day (10 mins). Following this they will dispose of their treatment and then complete a final assessment 1 hour later to assess the residual effects following chewing.
Testing will take place in a suite of testing facilities with participants visually isolated from each other.
- Conditions
- Cognitive Change
- Being tested
- Functional Gum, Basic Chewing Gum, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional GumDietary supplement
Functional gum containing a proprietary composition of a herbal extract and vitamins
Basic Chewing GumDietary supplement
Sugar-free chewing gum
PlaceboDietary supplement
Sugar-free tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sugar-free tablet Receives: Dietary Supplement: Placebo |
| Basic sugar-free gum | Active comparator | Sugar-free chewing gum Receives: Dietary Supplement: Basic Chewing Gum |
| Functional gum | Experimental | Sugar-free chewing gum with functional ingredients Receives: Dietary Supplement: Functional Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple Reaction Time
Cognitive Function - attention
Measured: During treatment consumption, adjusted for baseline
Choice Reaction Time
Cognitive Function - attention
Measured: During treatment consumption, adjusted for baseline
Digit Vigilance
Cognitive Function - attention
Measured: During treatment consumption, adjusted for baseline
Simple Reaction Time
Cognitive Function - attention
Measured: 1-hour post-consumption, adjusted for baseline
Choice Reaction Time
Cognitive Function - attention
Measured: 1-hour post-consumption, adjusted for baseline
Digit Vigilance
Cognitive Function - attention
Measured: 1-hour post-consumption, adjusted for baseline
Secondary outcomes (8)
COMPASS VAMS (Visual Analogue Mood Scales)
Mood
Measured: During treatment consumption, adjusted for baseline
Concentration VAS (Visual Analogue Scale)
Mood
Measured: During treatment consumption, adjusted for baseline
Focused VAS (Visual Analogue Scale)
Mood
Measured: During treatment consumption, adjusted for baseline
Mentally tired VAS (Visual Analogue Scale)
Mood
Measured: During treatment consumption, adjusted for baseline
COMPASS VAMS (Visual Analogue Mood Scales)
Mood
Measured: 1-hour post-consumption, adjusted for baseline
Concentration VAS (Visual Analogue Scale)
Mood
Measured: 1-hour post-consumption, adjusted for baseline
Focused VAS (Visual Analogue Scale)
Mood
Measured: 1-hour post-consumption, adjusted for baseline
Mentally tired VAS (Visual Analogue Scale)
Mood
Measured: 1-hour post-consumption, adjusted for baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start5 Jul 2022
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Randomised, double-blind, placebo-controlled, counterbalanced crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Perfetti van Melle SPA
- Responsible party
- Principal investigator, Crystal Haskell-Ramsay, Northumbria University
- Investigators
- Crystal Haskell-Ramsay, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544500
- Sponsor's protocol ID
- 63O2
- Status last verified
- Dec 2022
- First submitted
- 8 Sep 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haworth E, Haskell-Ramsay CF. Immediate and residual effects of functional chewing gum on sustained attention and mood. Nutr Neurosci. 2025 Apr;28(4):439-447. doi: 10.1080/1028415X.2024.2379698. Epub 2024 Jul 23.
PubMed 39039933
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Residual Effects of Functional Chewing Gum on Concentration
- ClinicalTrials.gov ID
- NCT05544500
- Acronym / sponsor ID
- 63O2
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Perfetti van Melle SPA
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous research suggests that chewing gum may influence several functions including attention and alertness. Gum can also be used as a vehicle for delivering ingredients that have the ability to modulate attention and mood. This study will explore the effects of a functional gum containing a proprietary composition of a herbal extract and vitamins. These effects will be compared to the effects of a basic sugar-free gum and to a tablet which will include the same ingredients as the basic sugar-free gum. Effects will be explored on computerised measures of attention/concentration and via ratings of current mood. The study will assess the immediate effects of chewing gum as well as the effects 1 hour later.
There will be an initial remote screening session followed by visits to the laboratory on 4 separate occasions: an introductory/training visit and three active study days.
Detailed description
This randomised, double-blind, placebo-controlled, counterbalanced crossover study will assess the acute effects of chewing functional gum on measures of concentration and mental acuity in healthy participants in comparison to basic sugar free gum and placebo.
The trial will utilise the COMPASS cognitive assessment system and a series of subjective mood measures. The core cognitive assessment of study will employ a selection of tasks assessing performance within the 'Psychomotor Speed', 'Sustained Attention', and 'Decision Making' cognitive domains. Subjective changes in mood ('alertness', 'stress', 'tranquillity', concentration', 'focus' and 'mental tiredness') will also be assessed.
Assessments will take place at baseline, during treatment consumption and 1 hour post-dose to assess the residual effects following chewing.
Participants will have an initial remote screening session followed by visits to the laboratory on 4 separate occasions: an introductory/training visit (Day 0) and three active study days (Day 1, Day 2, and Day 3) spaced 2 days apart (+5 days).
The remote screening session will be completed via telephone call and will comprise: briefing on requirements of the study, obtaining of informed consent via completion of an online consent form, health screening, collection of demographic data, and completion of the Caffeine Consumption Questionnaire (CCQ).
The introductory/training visit to the laboratory will begin with physiological eligibility measures that cannot be completed remotely (e.g. height and weight, waist-to-hip ratio) followed by training on the cognitive and mood measures.
Following the introductory visit participants will attend the laboratory at either 10 am or 2 pm on three separate occasions (Day 1, Day 2, and Day 3) with testing time consistent within participants and counterbalanced across treatment orders. All testing days (will be identical, with the exception that the participants will consume a different treatment at each visit.
On each testing visit participants will be required to eat a standard meal at least 1 hour before testing and to abstain from alcohol and over the counter medications (including hay fever medications) for 24 hours and caffeinated products for 5 hours before testing (meal items should be kept consistent across visits). Participants will arrive to the laboratory at their allotted time and, following completion of the Case Report Form (to confirm continued compliance with inclusion/exclusion criteria), complete a baseline assessment for that day (10 mins). They will then be randomised to treatment order (Day 1 only). Participants will have a 10-minute rest before completing the tasks again whilst 'chewing' their allotted treatment for that day (10 mins). Following this they will dispose of their treatment and then complete a final assessment 1 hour later to assess the residual effects following chewing.
Testing will take place in a suite of testing facilities with participants visually isolated from each other.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised, double-blind, placebo-controlled, counterbalanced crossover study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSugar-free tablet |
| Basic sugar-free gum | Active comparator | Dietary Supplement: Basic Chewing GumSugar-free chewing gum |
| Functional gum | Experimental | Dietary Supplement: Functional GumSugar-free chewing gum with functional ingredients |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must self-assess themselves as being in good health
- Aged 18 to 35 years at the time of giving consent
- Report good oral health and chewing ability
- Proficient in English
Key exclusion criteria (11 listed)
- Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: There may be unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance.
- Are currently taking prescription medications NOTE: the explicit exception to this are contraceptive treatments for female participants, topical skin treatments e.g. for eczema, acne, and those taken 'as needed' in the treatment of hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening. Use of any medications which impact mood or cognitive function e.g. anti depressants, anti anxiety medications etc. are not permitted.
- Have undergone dental treatment 1 week before the test, or needs or is planning dental treatments during the study (excluding routine dental check-up)
- Have a Body Mass Index (BMI) outside of the range 18.5-30 kg/m2
- Are pregnant, seeking to become pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional GumFunctional gum containing a proprietary composition of a herbal extract and vitamins | Dietary supplement | Functional gum |
| Basic Chewing GumSugar-free chewing gum | Dietary supplement | Basic sugar-free gum |
| PlaceboSugar-free tablet | Dietary supplement | Placebo |
Primary outcome
Simple Reaction Time
Time frame: During treatment consumption, adjusted for baseline
Cognitive Function - attention
Choice Reaction Time
Time frame: During treatment consumption, adjusted for baseline
Cognitive Function - attention
Digit Vigilance
Time frame: During treatment consumption, adjusted for baseline
Cognitive Function - attention
Simple Reaction Time
Time frame: 1-hour post-consumption, adjusted for baseline
Cognitive Function - attention
Choice Reaction Time
Time frame: 1-hour post-consumption, adjusted for baseline
Cognitive Function - attention
Digit Vigilance
Time frame: 1-hour post-consumption, adjusted for baseline
Cognitive Function - attention
8 secondary outcomes
COMPASS VAMS (Visual Analogue Mood Scales)
Time frame: During treatment consumption, adjusted for baseline
Concentration VAS (Visual Analogue Scale)
Time frame: During treatment consumption, adjusted for baseline
Focused VAS (Visual Analogue Scale)
Time frame: During treatment consumption, adjusted for baseline
Mentally tired VAS (Visual Analogue Scale)
Time frame: During treatment consumption, adjusted for baseline
COMPASS VAMS (Visual Analogue Mood Scales)
Time frame: 1-hour post-consumption, adjusted for baseline
Concentration VAS (Visual Analogue Scale)
Time frame: 1-hour post-consumption, adjusted for baseline
Focused VAS (Visual Analogue Scale)
Time frame: 1-hour post-consumption, adjusted for baseline
Mentally tired VAS (Visual Analogue Scale)
Time frame: 1-hour post-consumption, adjusted for baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Derived from this study: PubMed 39039933Haworth E, Haskell-Ramsay CF. Immediate and residual effects of functional chewing gum on sustained attention and mood. Nutr Neurosci. 2025 Apr;28(4):439-447. doi: 10.1080/1028415X.2024.2379698. Epub 2024 Jul 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Haskell-Ramsay principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Gum and Basic Chewing Gum in people with Cognitive Change, run by Northumbria University 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 4 inclusion and 11 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 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
Simple Reaction Time (time frame: During treatment consumption, adjusted for baseline). The study lists 6 primary outcomes in all. 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 NCT05544500, 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 Dec 2022.