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OpenTrials
Completed

NCT Number: NCT04851899

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exercise & Sport Nutrition Lab

College Station, Texas, 77843-4253, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Phaeosol low dose

Dietary Supplement

1 Phaeosol softgel of 440mg/day and 1 placebo softgel of 500mg/day (look like softgel of Phaeosol product) + 1 capsule of 440mg/day of natural stimulant Subjects were instructed to take the study supplement or placebo once daily for 1 months (±2 days). The first and the last doses will be administered at the clinical site during Visit 2 (Experiment 1) and Visit 3 (Experiment 2, respectively).

Phaeosol high dose

Dietary Supplement

2 Phaeosol softgels of 440mg/day + 1 capsule of 440mg/day of natural stimulant. Subjects were instructed to take the study supplement or placebo once daily for 1 months (±2 days). The first and the last doses will be administered at the clinical site during Visit 2 (Experiment 1) and Visit 3 (Experiment 2, respectively).

Placebo

Dietary Supplement

2 placebo softgels of 440mg/day (look like softgel of Phaeosol product) + 1 capsule of 500mg/day containing Microcellulose (look like capsule of natural stimulant). Subjects were instructed to take the study supplement or placebo once daily for 1 months (±2 days). The first and the last doses will be administered at the clinical site during Visit 2 (Experiment 1) and Visit 3 (Experiment 2, respectively).

Primary outcomes

  1. Reaction time

    Time frame: From week 0 to week 4

    Change in reaction time - Light tracking test

  2. General attention

    Time frame: From week 0 to week 4

    Change in general attention score - Go no go task test

  3. Sustained attention

    Time frame: From week 0 to week 4

    Change in sustained attention score - Psychomotor vigilance task test

  4. Attention shifting

    Time frame: From week 0 to week 4

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

Secondary outcomes

  1. Gaming performance

    Time frame: From week 0 to week 4

    Change in gaming performance score from 0 to 100 - Higher scores mean a better outcome

  2. Mood state

    Time frame: From week 0 to week 4

    Change in Mood state questionnaire score from 0 to 100 - Higher scores mean a better outcome - Profil of Mood state questionnaire

  3. Sleep quality

    Time frame: From week 0 to week 4

    Change in sleep quality questionnaire score from 0 to 100 - Higher scores mean a better outcome

  4. Eyes irritability

    Time frame: From week 0 to week 4

    Change in eyes irritability score -Visual analogic scale from 0 to 100 - Higher scores mean a worse outcome

  5. Global fatigue

    Time frame: From week 0 to week 4

    Change in global fatigue score - Visual analogic scale from 0 to 100 - higher scores mean a worse outcome

Sponsors and collaborators

Lead sponsor

Microphyt

Industry

Collaborators

  • Texas A&M University

Registry information

Acronym: PHAEOSOL-TWO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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