Nutrition21 Study 1 (N21-1)

April 7, 2025 updated by: Richard B. Kreider, Texas A&M University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • College Station, Texas, United States, 77843
        • Human Clinical Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Treatment 1
1,600 mg of Placebo (maltodextrin)
Dietary supplement: Placebo
Maltodextrin
Active Comparator: Treatment 2
1,500 mg of ASI (bonded arginine silicate) + 100 mg of inositol (nooLVL)
Dietary supplement: Arginine
Bonded Arginine Silicate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
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
Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
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
Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Cognitive Function: Sternberg Task Test
Time Frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Working Memory Test
Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
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
Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
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
Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gaming Score and Progression
Time Frame: Measured prior to supplementation (Pre) and after 60 minutes.
Score and Progression
Measured prior to supplementation (Pre) and after 60 minutes.
Stimulant Sensitivity Questionnaire
Time Frame: Measured prior to supplementation (Pre) and after 60 minutes.
Stimulant Sensitivity
Measured prior to supplementation (Pre) and after 60 minutes.
Side Effects Questionnaire
Time Frame: Measured prior to supplementation (Pre) and after 60 minutes.
Side Effects
Measured prior to supplementation (Pre) and after 60 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas A&M University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nutrition 21, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2020-0181D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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