Immediate and Residual Effects of Functional Chewing Gum on Concentration
Condition: Cognitive Change
Study type: Interventional

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.
    

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.
    

Intervention name(s): Functional Gum; Basic Chewing Gum; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Functional gum containing a proprietary composition of a herbal extract and vitamins; Sugar-free chewing gum; Sugar-free tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, double-blind, placebo-controlled, counterbalanced crossover study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other