NCT04851899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

April 15, 2021

Last Update Submit

September 22, 2022

Conditions

Keywords

FucoxanthinMicroalgaeGaming performanceE-sportsCognitive performanceEnergy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • Gaming performance

    From week 0 to week 4

  • Mood state

    From week 0 to week 4

  • Sleep quality

    From week 0 to week 4

  • Eyes irritability

    From week 0 to week 4

  • Global fatigue

    From week 0 to week 4

Study Arms (3)

Low dose Phaeosol group

EXPERIMENTAL

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

High dose Phaeosol group

EXPERIMENTAL

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

Dietary Supplement: Phaeosol high dose

Placebo group

PLACEBO COMPARATOR

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

Interventions

Phaeosol low doseDIETARY_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).

Low dose Phaeosol group
Phaeosol high doseDIETARY_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).

High dose Phaeosol group
PlaceboDIETARY_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).

Placebo group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise & Sport Nutrition Lab

College Station, Texas, 77843-4253, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Richard Kreider, Professor

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 21, 2021

Study Start

April 26, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations