Nutritional SupplementationN21-1NCT04828278
Nutrition21 Study 1
A study testing Arginine in people with Nutritional Supplementation, run by Texas A&M University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Supplementation
- What is being tested?
- Arginine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Clinical Research Facility
College Station, Texas, 77843
About this study
Official title: Effects of nooLVL Ingestion on Reaction Time and Cognitive Function in Gamers
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.
Read the 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.
- Conditions
- Nutritional Supplementation
- Being tested
- Arginine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArginineDietary supplement
Bonded Arginine Silicate
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Placebo comparator | 1,600 mg of Placebo (maltodextrin) Receives: Dietary Supplement: Placebo |
| Treatment 2 | Active comparator | 1,500 mg of ASI (bonded arginine silicate) + 100 mg of inositol (nooLVL) Receives: Dietary Supplement: Arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function: Go No-Go Task Test
General Attention Test
Measured: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Cognitive Function: Phychomotor Vigilance Task Test
Sustained Attention Test
Measured: 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: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Cognitive Function: Sternberg Task Test
Working Memory Test
Measured: 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: 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: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Secondary outcomes (3)
Gaming Score and Progression
Score and Progression
Measured: Measured prior to supplementation (Pre) and after 60 minutes.
Stimulant Sensitivity Questionnaire
Stimulant Sensitivity
Measured: Measured prior to supplementation (Pre) and after 60 minutes.
Side Effects Questionnaire
Side Effects
Measured: Measured prior to supplementation (Pre) and after 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start6 Apr 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Intervention Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrition 21, Inc.
- Responsible party
- Principal investigator, Richard B. Kreider, Texas A&M University
- Investigators
- Richard B Kreider, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828278
- Sponsor's protocol ID
- IRB2020-0181D
- Acronym
- N21-1
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2021
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of nooLVL Ingestion on Reaction Time and Cognitive Function in Gamers
- ClinicalTrials.gov ID
- NCT04828278
- Acronym / sponsor ID
- N21-1 / IRB2020-0181D
- Conditions
- Nutritional Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Nutrition 21, Inc.
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Crossover Intervention Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Placebo comparator | Dietary Supplement: Placebo1,600 mg of Placebo (maltodextrin) |
| Treatment 2 | Active comparator | Dietary Supplement: Arginine1,500 mg of ASI (bonded arginine silicate) + 100 mg of inositol (nooLVL) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArginineBonded Arginine Silicate | Dietary supplement | Treatment 2 |
| PlaceboMaltodextrin | Dietary supplement | Treatment 1 |
Primary outcome
Cognitive Function: Go No-Go Task Test
Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
General Attention Test
Cognitive Function: Phychomotor Vigilance Task Test
Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Sustained Attention Test
Cognitive Function: Berg-Washington Card Sorting Task Test
Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Attention Shifting Test
Cognitive Function: Sternberg Task Test
Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Working Memory Test
Cognitive Function: Cambridge Brain Sciences Reasoning and Concentration Test
Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Reasoning and Concentration Test
Cognitive Function: Light Tracking Reaction Time Test
Time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).
Reaction Time Test
3 secondary outcomes
Gaming Score and Progression
Time frame: Measured prior to supplementation (Pre) and after 60 minutes.
Stimulant Sensitivity Questionnaire
Time frame: Measured prior to supplementation (Pre) and after 60 minutes.
Side Effects Questionnaire
Time frame: Measured prior to supplementation (Pre) and after 60 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B Kreider, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine in people with Nutritional Supplementation, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function: Go No-Go Task Test (time frame: Measured prior to supplementation (Pre-Gaming), and after 15 and 60 minutes (Post-Gaming).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.