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临床试验/NCT07047105
NCT07047105已完成不适用

Investigation of the Acute Effects of Nepalese Pepper Extract (Zanthoxylum Armatum DC) on Cognitive Function, Mood and Gaming Performance in Young, Healthy, Competitive Gamers

Northumbria University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2025年6月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Speed of Attention

研究概览

简要总结

The goal of this clinical trial is to learn if a Nepalese Pepper Extract (Zanthoxlum Armatum, ZA) supplement can improve cognitive performance and mental abilities in competitive gamers aged 16 to 34. The main questions it aims to answer are:

  1. Does ZA supplement improve cognitive abilities like attention, memory, and decision-making?
  2. What is the most effective dose of ZA supplement (300mg vs 150mg)?
  3. How do the effects of ZA supplement compare to caffeine?

Researchers will compare four different treatments (high-dose ZA, low-dose ZA, caffeine, and placebo) to see if ZA supplement produces better cognitive performance than placebo and how it compares to caffeine**.

Participants will:

  • Complete a screening visit with health checks and training on computer tasks
  • Attend four testing visits (7-14 days apart) where they receive different treatments
  • Avoid alcohol and energy drinks for 24 hours before each visit, and caffeine from waking
  • Take assigned treatment at 11:30am and complete cognitive tests at -1, 1, 3, and 5 hours in relation to dose.
  • Complete mood questionnaires, sleep assessments, and gaming-specific tasks (aim training, character control)
  • Wear heart rate monitors during testing
  • Eat standardized meals provided during visits
  • Play competitive games at home in the evening and complete performance questionnaires

详细描述

Zanthoxylum armatum DC (ZA), also known as Nepalese pepper (or TImut 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 80 mg 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, and the differences could be attributed to distinct changes over time. For the acute effects there may be a cholinergic mechanism at play, with previous research suggesting that there has been 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. A similar study on the cognitive effects of a multi-ingredient herbal supplement also resulted in speed of cognition improvement. Although this herbal remedy did not contain ZA or hydroxy α-sanshool, it did contain short chain fatty acids and terpenes suggesting a similar mechanism could be at work to improve neural efficiency.

An increasing area of interest for performance research is in the world of Esports and competitive gaming, where cognitive abilities are paramount. As with non-digital sports, 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 capabilities. Alongside these cognitive factors, the importance of personal social and emotional competencies within esports has been explored through the creation of a detailed competence model of digital games. Factors such as self-efficacy, mood, self-control, personality traits and emotional self-regulation have displayed correlations with traditional sport performance and therefore it would be expected improvements in these areas would also create better results for gamers. Within esports, viewership is overwhelmingly dominated by either Massive Online Battle Arena's (MOBA) and First Person Shooters (FPS), according to peak viewing statistics in recent years. It has been noted that FPS and MOBA game types share a similar fast paced, high intensity element which separates them from Real-time Strategy (RTS) games, however despite this the contrast in player character control mechanisms creates distinct performance metrics. Consequently, studies looking to analyse game performance across different genre players should incorporate genre-specific game performance measurement tools, the simplest of which would be in-game rank, but could extend to more detailed in-game metrics.

Cognitive tests provide a useful measure of the varying domains of mental performance, with a long-established history of validated measures of perception, attention and concentration, memory, executive function and processing speed. Given their broad range of applicability, measures of cognition may be able to map onto varying game genre competencies, as has been seen through research on numeric ability and flexible thinking, establishing some general abilities that persist across all game genres as fundamental cognitive abilities for performance.

One aspect common to all esports players is the prolonged nature of training and gameplay, requiring sustained attention, resulting in high mental demand and fatigue. Energy drink consumption is high within gamers; marketing of these products includes claims of mental fatigue attenuation and maintaining alertness during game play and several energy drink companies also provide sponsorship for esports teams. An emerging area of research considers the potential to enhance gaming performance following administration of various nootropics, primarily focussing on highly caffeinated energy products. Notably here, following 3 mg/kg caffeine, professional gamers performed quicker during a simple reaction time task, alongside quicker and more accurate performance on a first-person shooting task. Similarly, following acute supplementation with 125 mg caffeine, participants were more accurate during a tracking task. Within the same trial, following a combined supplement of caffeine, methylliberine and theacrine (125, 75 and 50 mg, respectively), improvements were observed in visuospatial working memory, alongside quicker kill time within a first-person shooter game and improved self-assessed performance, suggesting a potential synergistic effect when co-supplementing, rather than administering caffeine in isolation. A second trial using the same combined supplement that focused on traditional cognitive test outcomes reported improved performance on the Flanker Test of Inhibitory Control and quicker reaction time on the Psychomotor Vigilance Task; alongside increased self-reported alertness.

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)

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 34 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 16 to 34 years inclusive
  • Males and females
  • Self-report of good health
  • Usually a regular (at least once per week) player of competitive multiplayer games, (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 hour prior to attending testing.
  • Have relevant food intolerances/sensitivities, including caffeine sensitivity.
  • 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 they are 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 150mg

Experimental

150mg dosage of Nepalese Pepper (Zanthoxylum Armatum) extract in capsule form. Consumed during testing visit to measure acute effects over day of consumption.

干预措施: Nepalese Pepper (Zanthoxylum Armatum) extract 150mg (Dietary Supplement)

ZA 300mg

Experimental

300mg dosage of Nepalese Pepper (Zanthoxylum Armatum) extract in capsule form. Consumed during testing visit to measure acute effects over day of consumption.

干预措施: Nepalese Pepper (Zanthoxylum Armatum) extract 300mg (Dietary Supplement)

Placebo

Placebo Comparator

Inert placebo, Microcristalline Cellulose MCC, delivered in capsule in form.

干预措施: Placebo (Dietary Supplement)

Caffeine

Active Comparator

75mg dose of caffeine (Caffeine anhydrous Pulver) in capsule form. Consumed during testing visit to measure acute effects over day of consumption.

干预措施: Caffeine 75mg (Dietary Supplement)

结局指标

主要结局

Speed of Attention

时间窗: Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.

Score calculated through performance on Rapid Visual Information Processing, Simple Reaction Time and Choice Reaction Time

Subjective Fatigue

时间窗: Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.

Following completion of Cognitive Demand Battery subjective fatigue will be assessed through self assessment of fatigue levels.

次要结局

  • Working memory(Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.)
  • First Person Shooter Aiming Ability(Prior to intervention on each testing visit for each arm, along with post dose 40 minutes, post dose 160 minutes and post dose 220 minutes.)
  • Finger Tapping Task(Prior to intervention on each testing visit for each arm, along with post dose 40 minutes, post dose 160 minutes and post dose 220 minutes.)
  • MOBA Control Ability(Prior to intervention on each testing visit for each arm, along with post dose 40 minutes, post dose 160 minutes and post dose 220 minutes.)
  • Accuracy of Attention(Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.)
  • Accuracy of Performance(Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.)
  • Executive Function(Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.)
  • Heart Rate Variability (HRV)(Prior to intervention on each testing visit for each arm, along with post dose 40 minutes, post dose 160 minutes and post dose 220 minutes.)
  • Multi Tasking Ability(Prior to intervention on each testing visit for each arm, along with post dose 40 minutes, post dose 160 minutes and post dose 220 minutes.)
  • Speed of Performance(Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.)
  • Mood(Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.)
  • Subjective Gameplay Performance(At home on the evening at least 6 hours post dose, on each testing visit following gameplay.)
  • Speed of memory(Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.)
  • Episodic memory(Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.)
  • Tracked Game Performance(At home on the evening at least 6 hours post dose, on each testing visit following gameplay.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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