Nutrition21 Study 1

NCT04828278 | Completed DMC

• 1 other identifier: IRB2020-0181D
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Supplementation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Gaming Score and Progression

  Measured prior to supplementation (Pre) and after 60 minutes.

• Stimulant Sensitivity Questionnaire

  Measured prior to supplementation (Pre) and after 60 minutes.

• Side Effects Questionnaire

  Measured prior to supplementation (Pre) and after 60 minutes.

Study Arms (2)

Treatment 1

PLACEBO COMPARATOR

1,600 mg of Placebo (maltodextrin)

Dietary Supplement: Placebo

Treatment 2

ACTIVE COMPARATOR

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

Dietary Supplement: Arginine

Interventions

Arginine DIETARY_SUPPLEMENT

Bonded Arginine Silicate

Treatment 2

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Treatment 1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Texas A&M University: lead
• Nutrition 21, Inc.: collaborator

Study Sites (1)

Human Clinical Research Facility

College Station, Texas, 77843, United States

Location

MeSH Terms

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Richard B Kreider, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Human Clinical Research Facility

Model Details: Crossover Intervention Trial

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: April 6, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)