Immediate and Residual Effects of Functional Chewing Gum on Concentration

NCT05544500 | Completed

• 1 other identifier: 63O2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (6)

• Simple Reaction Time

  Cognitive Function - attention

  During treatment consumption, adjusted for baseline

• Choice Reaction Time

  Cognitive Function - attention

  During treatment consumption, adjusted for baseline

• Digit Vigilance

  Cognitive Function - attention

  During treatment consumption, adjusted for baseline

• Simple Reaction Time

  Cognitive Function - attention

  1-hour post-consumption, adjusted for baseline

• Choice Reaction Time

  Cognitive Function - attention

  1-hour post-consumption, adjusted for baseline

• Digit Vigilance

  Cognitive Function - attention

  1-hour post-consumption, adjusted for baseline

Secondary Outcomes (8)

• COMPASS VAMS (Visual Analogue Mood Scales)

  During treatment consumption, adjusted for baseline

• Concentration VAS (Visual Analogue Scale)

  During treatment consumption, adjusted for baseline

• Focused VAS (Visual Analogue Scale)

  During treatment consumption, adjusted for baseline

• Mentally tired VAS (Visual Analogue Scale)

  During treatment consumption, adjusted for baseline

• COMPASS VAMS (Visual Analogue Mood Scales)

  1-hour post-consumption, adjusted for baseline

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Sugar-free tablet

Dietary Supplement: Placebo

Basic sugar-free gum

ACTIVE COMPARATOR

Sugar-free chewing gum

Dietary Supplement: Basic Chewing Gum

Functional gum

EXPERIMENTAL

Sugar-free chewing gum with functional ingredients

Dietary Supplement: Functional Gum

Interventions

Functional Gum DIETARY_SUPPLEMENT

Functional gum containing a proprietary composition of a herbal extract and vitamins

Functional gum

Basic Chewing Gum DIETARY_SUPPLEMENT

Sugar-free chewing gum

Basic sugar-free gum

Placebo DIETARY_SUPPLEMENT

Sugar-free tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Northumbria University: lead
• Perfetti van Melle SPA: collaborator

Study Sites (1)

Department of Psychology, Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39039933 DERIVED

Study Officials

• Crystal Haskell-Ramsay

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised, double-blind, placebo-controlled, counterbalanced crossover study

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 16, 2022
• Study Start: July 5, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)