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

NCT ID: NCT04851899

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2022-06-01

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.

Conditions

Cognitive Function; Video Gamers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Phaeosol low dose

Intervention Type: 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).

High dose Phaeosol group

2 Phaeosol softgels of 440mg/day + 1 capsule of 440mg/day of natural stimulant

Group Type: EXPERIMENTAL

Phaeosol high dose

Intervention Type: 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 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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas A&M University

OTHER

Sponsor Role: collaborator

Microphyt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Kreider, Professor

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

Exercise & Sport Nutrition Lab

College Station, Texas, United States

Countries

United States

References

Leonard M, Maury J, Dickerson B, Gonzalez DE, Kendra J, Jenkins V, Nottingham K, Yoo C, Xing D, Ko J, Pradelles R, Faries M, Kephart W, Sowinski R, Rasmussen CJ, Kreider RB. Effects of Dietary Supplementation of a Microalgae Extract Containing Fucoxanthin Combined with Guarana on Cognitive Function and Gaming Performance. Nutrients. 2023 Apr 15;15(8):1918. doi: 10.3390/nu15081918.

Reference Type: DERIVED

PMID: 37111136 (View on PubMed)

Other Identifiers

IRB2021-0219

Identifier Type: -

Identifier Source: org_study_id