Nutrition21 Study 1

Nutritional Supplementation Clinical Trial

— N21-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828278
• Other study ID #: IRB2020-0181D
• Status: Completed
• Phase: N/A
• Start date: April 6, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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;

Related Conditions & MeSH terms

• Nutritional Supplementation

Intervention

Dietary Supplement:
• Arginine
Bonded Arginine Silicate
• Placebo
Maltodextrin

Locations

Country	Name	City	State
United States	Human Clinical Research Facility	College Station	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Nutrition 21, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Function: Go No-Go Task Test	General Attention Test	Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Primary	Cognitive Function: Phychomotor Vigilance Task Test	Sustained Attention Test	Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Primary	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).
Primary	Cognitive Function: Sternberg Task Test	Working Memory Test	Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Primary	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).
Primary	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	Gaming Score and Progression	Score and Progression	Measured prior to supplementation (Pre) and after 60 minutes.
Secondary	Stimulant Sensitivity Questionnaire	Stimulant Sensitivity	Measured prior to supplementation (Pre) and after 60 minutes.
Secondary	Side Effects Questionnaire	Side Effects	Measured prior to supplementation (Pre) and after 60 minutes.