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Cognitive FunctionPHAEOSOL-TWONCT04851899

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

A study testing Phaeosol low dose and Phaeosol high dose in people with Cognitive Function and Video Gamers, run by Microphyt at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Function, Video Gamers
What is being tested?
Phaeosol low dose and Phaeosol high dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
26 Apr 2021to 1 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Exercise & Sport Nutrition Lab

    College Station, Texas, 77843-4253

Other trials in United States

About this study

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.

Being tested
Phaeosol low dose, Phaeosol high dose, Placebo
Keywords
Fucoxanthin, Microalgae, Gaming performance, E-sports, Cognitive performance, Energy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • 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).

  • 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).

Study groups in NCT04851899
Study groupRoleWhat they receive
Low dose Phaeosol groupExperimental1 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
Receives: Dietary Supplement: Phaeosol low dose
High dose Phaeosol groupExperimental2 Phaeosol softgels of 440mg/day + 1 capsule of 440mg/day of natural stimulant
Receives: Dietary Supplement: Phaeosol high dose
Placebo groupPlacebo comparator2 placebo softgels of 440mg/day (look like softgel of Phaeosol product) + 1 capsule of 440mg/day containing Microcellulose (look like capsule of natural stimulant)
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reaction time

    Change in reaction time - Light tracking test

    Measured: From week 0 to week 4

  2. General attention

    Change in general attention score - Go no go task test

    Measured: From week 0 to week 4

  3. Sustained attention

    Change in sustained attention score - Psychomotor vigilance task test

    Measured: From week 0 to week 4

  4. Attention shifting

    Change in attention shifting score - Berg-Washington card sorting task test

    Measured: From week 0 to week 4

Secondary outcomes (5)

  1. Gaming performance

    Change in gaming performance score from 0 to 100 - Higher scores mean a better outcome

    Measured: From week 0 to week 4

  2. Mood state

    Change in Mood state questionnaire score from 0 to 100 - Higher scores mean a better outcome - Profil of Mood state questionnaire

    Measured: From week 0 to week 4

  3. Sleep quality

    Change in sleep quality questionnaire score from 0 to 100 - Higher scores mean a better outcome

    Measured: From week 0 to week 4

  4. Eyes irritability

    Change in eyes irritability score -Visual analogic scale from 0 to 100 - Higher scores mean a worse outcome

    Measured: From week 0 to week 4

  5. Global fatigue

    Change in global fatigue score - Visual analogic scale from 0 to 100 - higher scores mean a worse outcome

    Measured: From week 0 to week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start26 Apr 2021
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04851899
Sponsor's protocol ID
IRB2021-0219
Acronym
PHAEOSOL-TWO
Status last verified
Sep 2022
First submitted
15 Apr 2021
Last updated
23 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37111136

Questions about this trial

What is this clinical trial studying?

A study testing Phaeosol low dose and Phaeosol high dose in people with Cognitive Function and Video Gamers, run by Microphyt at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reaction time (time frame: From week 0 to week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04851899, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.

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