Clinical trial NCT04851899: Efficacy of a Microalgae Extract PhaeoSOL Combined With Natural Stimulant on Cognitive Function and Gaming Performance of Video Gamers
Official title: Efficacy of a Microalgae Extract PhaeoSOL Combined With Natural Stimulant on Cognitive Function and Gaming Performance of Video Gamers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Video Gamers
Keywords: Fucoxanthin
Microalgae
Gaming performance
E-sports
Cognitive performance
Energy
Lead sponsor: Microphyt
Sponsor class: INDUSTRY
Collaborators: name: Texas A&M University
First posted: 2021-04-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women;
2. Between 18 and 40 years;
3. Self-reported history of playing video games for 5 or more hours per week for 6 months prior to screening;
4. BMI between 18 and 34.9 Kg/m2 ;
5. 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;
6. No recent ingestion (\<2weeks) of dietary supplement that affect cognitive function;
7. Be able to give written informed consent and to consume the investigational product daily for the duration of the study;
8. Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance)
9. Willing to maintain consistent sleep duration the evening before study visits.
10. Are agreed to continue their patterned use of the game between study visits

Exclusion Criteria:

1. refrain from caffeine and alcohol for 12 hours prior to each study visits;
2. 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 ;
3. are women who are pregnant, breastfeeding, or wish to become pregnant during the study;
4. have an untreated psychotic or major depressive disorder or any history of cognitive deficit;
5. have an uncontrolled hypertension/diabetes/thyroid/heart disease disease, cancer etc.);
6. have a significant neurological disease;
7. have planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
8. have a history within previous 12 months of alcohol or substance abuse;
9. have known allergy to any of the ingredients in the supplement product
10. are not willing to supply their own gaming system and/or game

Primary outcomes:
measure: Reaction time
timeFrame: From week 0 to week 4
measure: General attention
timeFrame: From week 0 to week 4
measure: Sustained attention
timeFrame: From week 0 to week 4
measure: Attention shifting
timeFrame: From week 0 to week 4
Secondary outcomes:
measure: Gaming performance
timeFrame: From week 0 to week 4
measure: Mood state
timeFrame: From week 0 to week 4
measure: Sleep quality
timeFrame: From week 0 to week 4
measure: Eyes irritability
timeFrame: From week 0 to week 4
measure: Global fatigue
timeFrame: From week 0 to week 4
Other outcomes:
Locations:
city: College Station
country: United States
facility: Exercise & Sport Nutrition Lab
state: Texas
Study officials:
affiliation: Texas A&M University
name: Richard Kreider, Professor
role: PRINCIPAL_INVESTIGATOR
References: