Nutrition21 Study 1

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nutritional Supplementation

Intervention / Treatment
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* Dietary Supplement: Arginine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Intervention Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Treatment 1<br>1,600 mg of Placebo (maltodextrin) | Dietary Supplement: Placebo<br>* Maltodextrin<br>|
| Active Comparator: Treatment 2<br>1,500 mg of ASI (bonded arginine silicate) + 100 mg of inositol (nooLVL) | Dietary Supplement: Arginine<br>* Bonded Arginine Silicate<br>|

What is the study measuring?
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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. |