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Completed

NCT Number: NCT04828278

Nutrition21 Study 1

The purpose of this study is to determine the effects of nooLVL containing arginine and inositol supplementation on executive function and memory prior to and following playing video games.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Clinical Research Facility

College Station, Texas, 77843, United States

About this study

Gaming or "E-Sports" has become a very popular activity particularly among younger individuals. It requires quick reactions, executive function, memory and fine motor skill. In E-Sport competitions and tournaments, E-Sport players often play for hours per session over a series of days. Thus, the ability to maintain cognitive and executive function, concentration and fine motor skill is paramount. Two recent studies have evaluated the effects of ingesting bonded arginine silicate (ASI) and ASI with additional inositol on cognitive function. In the first study, ASI supplementation (1,500 mg/d for 3 days and 14 days) significantly improved the ability to perform complex cognitive tests requiring mental flexibility, processing speed and executive functioning. In the second study, adding 100 mg of inositol to the ASI significantly improved cognitive function in gamers after playing video games for one hour. This study is designed to assess the effects of bonded arginine silicate and inositol ingestion on reaction time and cognitive function prior to and following a 1-hour gaming challenge.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • They are a healthy male or female Gamer 18 to 40 years of age;
  • They have a Body Mass Index (BMI) between 18 and 34.9 kg/m2;
  • They are willing to supply their own operator-oriented action or stragegy video game that they have played 21 times over the last 3 months and the gaming platform with all accessories needed to play the chosen game;
  • They report no recent ingestion (<2 weeks) of dietary supplements that affect cognitive function including nitrates and nitrous oxide (NO2) promoting supplements;
  • They have a willingness to provide voluntary, written informed consent to participate in the study;

Exclusion criteria

  • They have known cardiovascular, metabolic and/or other diseases under the treatment of a physician requiring prescription (Rx) medication (birth control is allowed);
  • They have a history of cognitive dysfunction;
  • They have a known allergy to maltodextrin;
  • They have known allergies or asthma;
  • They have cirrhosis;
  • They have guanidinoacetate methyltransferase deficiency;
  • They have herpes;
  • They have abnormally low blood pressure;
  • They have had a recent heart attack (i.e., within one year);
  • They have kidney disease;
  • They have a surgery scheduled in the next 4-5 weeks;
  • Thye have had a gastrectomy;
  • They have a bipolar disorder;
  • They have an allergy to aspirin or tartrazine products;
  • They are pregnant or breast-feeding or plan to become pregnant in the next 4-5 weeks;

Treatment and study plan

Arginine

Dietary Supplement

Bonded Arginine Silicate

Placebo

Dietary Supplement

Maltodextrin

Primary outcomes

  1. Cognitive Function: Go No-Go Task Test

    Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).

    General Attention Test

  2. Cognitive Function: Phychomotor Vigilance Task Test

    Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).

    Sustained Attention Test

  3. Cognitive Function: Berg-Washington Card Sorting Task Test

    Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).

    Attention Shifting Test

  4. Cognitive Function: Sternberg Task Test

    Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).

    Working Memory Test

  5. Cognitive Function: Cambridge Brain Sciences Reasoning and Concentration Test

    Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).

    Reasoning and Concentration Test

  6. Cognitive Function: Light Tracking Reaction Time Test

    Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).

    Reaction Time Test

Secondary outcomes

  1. Gaming Score and Progression

    Time frame: Measured prior to supplementation (Pre) and after 60 minutes.

    Score and Progression

  2. Stimulant Sensitivity Questionnaire

    Time frame: Measured prior to supplementation (Pre) and after 60 minutes.

    Stimulant Sensitivity

  3. Side Effects Questionnaire

    Time frame: Measured prior to supplementation (Pre) and after 60 minutes.

    Side Effects

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Nutrition 21, Inc.

Registry information

Official study title

Effects of nooLVL Ingestion on Reaction Time and Cognitive Function in Gamers

Acronym: N21-1

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2021
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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