Nutrition21 Study 1 (N21-1)

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: Completed
• Conditions: Nutritional Supplementation
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Arginine

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: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Cognitive Function: Go No-Go Task Test	General Attention Test	Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Cognitive Function: Phychomotor Vigilance Task Test	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	Attention Shifting Test	Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Cognitive Function: Sternberg Task Test	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	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	Reaction Time Test	Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gaming Score and Progression	Score and Progression	Measured prior to supplementation (Pre) and after 60 minutes.
Stimulant Sensitivity Questionnaire	Stimulant Sensitivity	Measured prior to supplementation (Pre) and after 60 minutes.
Side Effects Questionnaire	Side Effects	Measured prior to supplementation (Pre) and after 60 minutes.

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Nutrition 21, Inc.
• Investigators: Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID 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