Clinical trial NCT04828278: Nutrition21 Study 1
Official title: Effects of nooLVL Ingestion on Reaction Time and Cognitive Function in Gamers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Supplementation
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Nutrition 21, Inc.
First posted: 2021-04-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Intervention Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Cognitive Function: Go No-Go Task Test
timeFrame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
measure: Cognitive Function: Phychomotor Vigilance Task Test
timeFrame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
measure: Cognitive Function: Berg-Washington Card Sorting Task Test
timeFrame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
measure: Cognitive Function: Sternberg Task Test
timeFrame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
measure: Cognitive Function: Cambridge Brain Sciences Reasoning and Concentration Test
timeFrame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
measure: Cognitive Function: Light Tracking Reaction Time Test
timeFrame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Secondary outcomes:
measure: Gaming Score and Progression
timeFrame: Measured prior to supplementation (Pre) and after 60 minutes.
measure: Stimulant Sensitivity Questionnaire
timeFrame: Measured prior to supplementation (Pre) and after 60 minutes.
measure: Side Effects Questionnaire
timeFrame: Measured prior to supplementation (Pre) and after 60 minutes.
Other outcomes:
Locations:
city: College Station
country: United States
facility: Human Clinical Research Facility
state: Texas
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References: