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临床试验/NCT04851899
NCT04851899已完成不适用

Efficacy of a Microalgae Extract PhaeoSOL Combined With Natural Stimulant on Cognitive Function and Gaming Performance of Video Gamers

Microphyt2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Microphyt
入组人数
60
试验地点
2
主要终点
General attention

研究概览

简要总结

Considering the important growing development of gaming in the world, this research area has developed considerably over the last few years. Even if it seems to be well admitted that video gamers showed better cognitive functions (e.g. visual selective attention, cognitive flexibility, task switching) parameters compared to non video gamers there is a constant concern for optimizing performance as for all other kind of athletes. However to our knowledge, only one randomized controlled trial have investigated the potential benefits of dietary supplementation on cognitive function and performance in video gamers. The use of microalgea as molecule of interest sources is a recent promising approach also to meet societal challenge as the maintain of biodiversity/landscape.

Thus, the purpose of this study is to examine whether acute (single-dose) and chronic (1 month) supplementation of Microphyt's phaeosol ingredients (BrainPhyt) ingested with or without a natural stimulant, would affect cognitive function and gaming performance in experienced video gamers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men and women;
  • Between 18 and 40 years;
  • Self-reported history of playing video games for 5 or more hours per week for 6 months prior to screening;
  • BMI between 18 and 34.9 Kg/m2 ;
  • Subjects agreed to supply their own operator-oriented action or strategy video game that they had played at least 21 times over the last 3 months;
  • No recent ingestion (<2weeks) of dietary supplement that affect cognitive function;
  • Be able to give written informed consent and to consume the investigational product daily for the duration of the study;
  • Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance)
  • Willing to maintain consistent sleep duration the evening before study visits.
  • Are agreed to continue their patterned use of the game between study visits

排除标准

  • refrain from caffeine and alcohol for 12 hours prior to each study visits;
  • consume dietary supplements that may affect cognition and/or with a stimulant effect (e.g. guarana, cocoa, ginseng, bacopa, Gingko biloba, guayusa, yerba mate, energy drinks, other products containing fucoxanthin) at least 7 days before Visit 2 ;
  • are women who are pregnant, breastfeeding, or wish to become pregnant during the study;
  • have an untreated psychotic or major depressive disorder or any history of cognitive deficit;
  • have an uncontrolled hypertension/diabetes/thyroid/heart disease disease, cancer etc.);
  • have a significant neurological disease;
  • have planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
  • have a history within previous 12 months of alcohol or substance abuse;
  • have known allergy to any of the ingredients in the supplement product
  • are not willing to supply their own gaming system and/or game

结局指标

主要结局

General attention

时间窗: From week 0 to week 4

Change in general attention score - Go no go task test

Sustained attention

时间窗: From week 0 to week 4

Change in sustained attention score - Psychomotor vigilance task test

Reaction time

时间窗: From week 0 to week 4

Change in reaction time - Light tracking test

Attention shifting

时间窗: From week 0 to week 4

Change in attention shifting score - Berg-Washington card sorting task test

次要结局

  • Mood state(From week 0 to week 4)
  • Gaming performance(From week 0 to week 4)
  • Global fatigue(From week 0 to week 4)
  • Sleep quality(From week 0 to week 4)
  • Eyes irritability(From week 0 to week 4)

研究者

发起方
Microphyt
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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