Nutrition21 Study 1

NCT ID: NCT04828278

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-06

Study Completion Date

2021-03-01

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.

Conditions

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Nutritional Supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Intervention Trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators
Double Blind

Study Groups

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Treatment 1

1,600 mg of Placebo (maltodextrin)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Treatment 2

1,500 mg of ASI (bonded arginine silicate) + 100 mg of inositol (nooLVL)

Group Type ACTIVE_COMPARATOR

Arginine

Intervention Type DIETARY_SUPPLEMENT

Bonded Arginine Silicate

Interventions

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Arginine

Bonded Arginine Silicate

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutrition 21, Inc.

INDUSTRY

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

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Richard B. Kreider

Executive Director, Human Clinical Research Facility

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard B Kreider, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

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Human Clinical Research Facility

College Station, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IRB2020-0181D

Identifier Type: -

Identifier Source: org_study_id

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