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

Cognitive Function Clinical Trial

— PHAEOSOL-TWO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04851899
• Other study ID #: IRB2021-0219
• Status: Completed
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2022
• Source: Microphyt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function

Intervention

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).
• 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
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).

Locations

Country	Name	City	State
United States	Exercise & Sport Nutrition Lab	College Station	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Microphyt	Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction time	Change in reaction time - Light tracking test	From week 0 to week 4
Primary	General attention	Change in general attention score - Go no go task test	From week 0 to week 4
Primary	Sustained attention	Change in sustained attention score - Psychomotor vigilance task test	From week 0 to week 4
Primary	Attention shifting	Change in attention shifting score - Berg-Washington card sorting task test	From week 0 to week 4
Secondary	Gaming performance	Change in gaming performance score from 0 to 100 - Higher scores mean a better outcome	From week 0 to week 4
Secondary	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
Secondary	Sleep quality	Change in sleep quality questionnaire score from 0 to 100 - Higher scores mean a better outcome	From week 0 to week 4
Secondary	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
Secondary	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