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

Sponsor

Microphyt (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04851899

Collaborator

Texas A&M University (Other)

Enrollment

Location

Arms

13.2

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Function Video Gamers	Dietary Supplement: Phaeosol low dose Dietary Supplement: Phaeosol high dose Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 26, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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