Efficacy of a Microalgae Extract PhaeoSOL Combined With Natural Stimulant on Cognitive Function and Gaming Performance of Video Gamers (PHAEOSOL-TWO)

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Video Gamers
• Intervention / Treatment: Dietary supplement: Phaeosol low dose; Dietary supplement: Phaeosol high dose; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77843-4253
      • Exercise & Sport Nutrition Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose Phaeosol group; 1 Phaeosol softgel of 440mg/day and 1 placebo softgel of 440mg/day look like softgel of Phaeosol product) + 1 capsule of 440mg/day of natural stimulant	Dietary supplement: Phaeosol low dose; 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).
Experimental: High dose Phaeosol group; 2 Phaeosol softgels of 440mg/day + 1 capsule of 440mg/day of natural stimulant	Dietary supplement: Phaeosol high dose; 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 Comparator: Placebo group; 2 placebo softgels of 440mg/day (look like softgel of Phaeosol product) + 1 capsule of 440mg/day containing Microcellulose (look like capsule of natural stimulant)	Dietary supplement: Placebo; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction time	Change in reaction time - Light tracking test	From week 0 to week 4
General attention	Change in general attention score - Go no go task test	From week 0 to week 4
Sustained attention	Change in sustained attention score - Psychomotor vigilance task test	From week 0 to week 4
Attention shifting	Change in attention shifting score - Berg-Washington card sorting task test	From week 0 to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gaming performance	Change in gaming performance score from 0 to 100 - Higher scores mean a better outcome	From week 0 to week 4
Mood state	Change in Mood state questionnaire score from 0 to 100 - Higher scores mean a better outcome - Profil of Mood state questionnaire	From week 0 to week 4
Sleep quality	Change in sleep quality questionnaire score from 0 to 100 - Higher scores mean a better outcome	From week 0 to week 4
Eyes irritability	Change in eyes irritability score -Visual analogic scale from 0 to 100 - Higher scores mean a worse outcome	From week 0 to week 4
Global fatigue	Change in global fatigue score - Visual analogic scale from 0 to 100 - higher scores mean a worse outcome	From week 0 to week 4

Collaborators and Investigators

• Sponsor: Microphyt
• Collaborators: Texas A&M University
• Investigators: Principal Investigator: Richard Kreider, Professor, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Energy; Cognitive performance; Microalgae; Fucoxanthin; Gaming performance; E-sports
• Other Study ID Numbers: IRB2021-0219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No