Investigation on the Chronic Effects of Nepalese Pepper (Zanthoxylum Armatum DC) on Cognitive Function, Mood and Gaming Performance in Young, Healthy, Action Video Gamers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Subjective Fatigue
研究概览
简要总结
The goal of this clinical trial is to learn if daily supplementation with a Nepalese Pepper Extract (Zanthoxylum Armatum, ZA) can improve cognitive performance and gaming performance in action video gamers aged 16 to 39, when taken over an extended period. The main questions it aims to answer are:
Does chronic (42-day) daily ZA supplementation improve speed of cognitive performance and reduce subjective mental fatigue? Do these effects translate into objective and self-reported improvements in gaming performance? Are there additional acute (within-session) effects at the end of a chronic supplementation period, on top of any chronic effect?
Researchers will compare 275mg daily ZA supplementation to placebo to see if chronic ZA produces better cognitive performance and lower fatigue than placebo. Participants will:
Complete a screening call and a training visit on the computerised cognitive tasks and gaming tasks Take a daily capsule (either ZA or placebo, depending on treatment order) each morning with food for 42 days, then switch to the other treatment for a further 42 days after a 2-week washout Attend four testing visits at the research centre: a baseline and an endpoint visit for each 42-day treatment period Avoid alcohol and energy drinks for 24 hours before each testing visit, and caffeine from waking Complete cognitive tests before dosing and 1 hour after dosing at each testing visit Complete mood and sleep questionnaires Wear a heart rate monitor at rest on arrival at each visit Complete gaming-specific tasks (aim training, MOBA character control, multi-tasking, finger tapping, Fitts' Law, multiple object tracking, collision prediction) Play their action video game of choice at home throughout each 42-day period and complete performance questionnaires
详细描述
Zanthoxylum armatum DC (ZA), also known as Nepalese pepper, contains numerous active chemicals throughout all parts of the organism. Traditionally used in the treatment of intestinal disorders, depression and as topical treatment for toothache, it is commonly ingested through the form of Daikenchuto, a traditional combination of the Zanthoxylum fruit with ginseng root, ginger rhizome and rice gluten. In recent years it has been established that ZA also possesses cognitive enhancing properties, with the primary active component revealed to be the fatty acid amide hydroxy α-sanshool. Additionally, ZA is rich in monoterpenes which have also been shown to positively affect cognition, and the combination of these compounds may lead to numerous improvements in brain function.
Through a double-blind placebo-controlled study, acute single dose administration of 80mg of ZA was shown to improve cognitive performance in 'Speed of Attention' and Rapid Visual Information Processing, a sustained attention task. In the same study, chronic (56 day) administration resulted in overall improvement in 'Speed of Performance', with more correct Serial 3 subtractions 3h post dose and lower mental fatigue compared to placebo during performance of the Cognitive Demand Battery (CDB). In both acute and chronic cases, the mechanisms underpinning the effects are currently unknown. For the acute effects there may be a cholinergic mechanism at play, with previous research suggesting a cholinesterase inhibitory effect from ZA. Meanwhile, the observed chronic improvements suggest a more general improvement in neural efficiency and processing speeds rather than the memory/attention benefits generally expected from cholinergic agents.
An increasing area of interest for performance research is in the world of Esports and competitive gaming, where cognitive abilities are paramount. Esport competition incurs physical and mental demands, including motor skills, mental agility, processing speed, motivation, executive function and, to a lower degree, physical exertion. Success hinges on mastering cognitive tasks such as visuospatial processing, cognitive workload, attention and cognitive control, hand-eye coordination, fast reaction times and quick decision-making. Within esports, viewership is overwhelmingly dominated by Massive Online Battle Arenas (MOBA) and First Person Shooters (FPS); despite sharing a similarly fast-paced, high-intensity element, the contrast in player character control mechanisms between these genres creates distinct performance metrics, meaning studies analysing game performance across genres should incorporate genre-specific measurement tools.
One aspect common to all esports players is the prolonged nature of training and gameplay, requiring sustained attention and resulting in high mental demand and fatigue. Energy drink consumption is high within gamers, and an emerging area of research considers the potential to enhance gaming performance via various nootropics, primarily highly caffeinated products. However, the high caffeine content in these products is linked to undesirable side effects including jitteriness, tension, and decreased sleep duration and quality, which can negatively impact both short- and long-term gaming performance. As gaming becomes a more viable career, gamers are likely to seek healthier alternatives, sparking interest in non-caffeinated options to combat mental fatigue and enhance gaming performance.
The previous acute study conducted by our group (53BS2) administered single doses of 150mg and 300mg of a powdered ZA formulation (SaraPepp™ Nu) to assess acute cognitive and mood effects against placebo and caffeine. The main aim of the current study is to investigate the chronic cognitive and mood effects of 275mg ZA administered daily over 42 days in young, healthy action video gamers, building on the chronic findings of Kennedy et al. (2019), in which 56-day ZA administration improved 'Speed of Performance' and reduced subjective mental fatigue relative to placebo. A crossover design with a 2-week washout period will allow for within-participant comparisons while controlling for individual differences. Additional aims include ascertaining whether chronic cognitive improvements translate into objective and subjective in-game performance improvements, deepening understanding of how action video game genres present differing cognitive gameplay requirements, and developing robust methods of assessing gameplay performance over an extended supplementation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Treatment will be blinded according to the randomisation schedule by a researcher who has no other involvement in the study.
入排标准
- 年龄范围
- 16 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 16 to 39 years inclusive
- •Males and females
- •Self-report of good health
- •Usually a regular (at least 5 hours per week on average) player of action video games, including but not limited to First-Person Shooters (FPS) and Massive Online Battle Arenas (MOBA), (prospective participants will be asked to contact the researchers to discuss their gaming habits if uncertain that they meet the criteria).
排除标准
- •Have any pre-existing medical condition/illness which will impact taking part in the study (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 exceptions to this are contraceptive treatments for female participants, and those taken 'as needed' in the treatment of asthma and hay fever. 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.
- •Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg); or have low blood pressure (systolic below 90 mm Hg or diastolic below 60 mm Hg)
- •Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
- •Are pregnant, seeking to become pregnant or lactating
- •Have learning and/or behavioural diagnoses such as dyslexia or ADHD
- •Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- •Smoke tobacco or vape nicotine or use nicotine replacement products
- •Excessive caffeine intake (> 500 mg per day). If participants consume energy drinks they will be asked to refrain from this for 24 hours prior to attending testing.
- •Have relevant food intolerances/sensitivities.
- •Have taken antibiotics within the past 4 weeks
- •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 taken are out of choice and not medically prescribed or advised)
- •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
- •Are currently participating in other clinical or nutrition intervention studies, or have done so in the past 4 weeks
- •Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
- •Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
- •Suffers from frequent migraines that require medication (more than or equal to 1 per month)
- •Sleep disorders or are taking sleep aid medication
- •Any known active infections
- •Are non-compliant with regards treatment consumption
研究组 & 干预措施
ZA 275mg
275mg daily dosage of Nepalese Pepper (Zanthoxylum Armatum) extract (SaraPepp™ Nu) in capsule form, taken once daily for 42 days, to measure chronic effects on cognition, mood and gaming performance.
干预措施: Nepalese Pepper (Zanthoxylum Armatum DC) extract 275mg (Dietary Supplement)
Placebo
Inert placebo, Microcrystalline Cellulose (MCC), delivered in capsule form, taken once daily each morning with food for 42 days.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Subjective Fatigue
时间窗: Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.
Self-assessed fatigue level following each of three completions of the Cognitive Demand Battery (CDB).
Speed of Performance
时间窗: Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.
Composite outcome derived from combined performance on Serial 3 Subtractions, Simple Reaction Time, Choice Reaction Time, Numeric Working Memory, RVIP, Delayed Picture Recognition, and Delayed Word Recognition tasks from the COMPASS battery.
次要结局
- Accuracy of Attention(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Speed of Attention(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Accuracy of Performance(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Working Memory(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Speed of Memory(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Episodic Memory(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Executive Function(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Mood(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Sleep Disturbance(Assessed on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Heart Rate Variability (HRV)(Assessed at rest upon arrival, prior to task performance or supplementation, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- First Person Shooter Aiming Ability(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- MOBA Control Ability(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Multi-Tasking Ability(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Finger Tapping Task(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Fitts' Law Task(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Multiple Object Tracking Task(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Collision Prediction Task(Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.)
- Subjective Gameplay Performance(At home, periodically throughout each 42-day supplementation period, following gameplay sessions.)