Immediate and Residual Effects of Functional Chewing Gum on Concentration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Simple Reaction Time
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Simple Reaction Time
时间窗: 1-hour post-consumption, adjusted for baseline
Cognitive Function - attention
Choice Reaction Time
时间窗: 1-hour post-consumption, adjusted for baseline
Cognitive Function - attention
Digit Vigilance
时间窗: 1-hour post-consumption, adjusted for baseline
Cognitive Function - attention
次要结局
- Focused VAS (Visual Analogue Scale)(1-hour post-consumption, adjusted for baseline)
- Concentration VAS (Visual Analogue Scale)(1-hour post-consumption, adjusted for baseline)
- Mentally tired VAS (Visual Analogue Scale)(1-hour post-consumption, adjusted for baseline)
- COMPASS VAMS (Visual Analogue Mood Scales)(1-hour post-consumption, adjusted for baseline)
研究者
Crystal Haskell-Ramsay
Professor
Northumbria University