- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07533045
Effects of Paraxanthine Supplementation on eSport Performancre (EPX)
This study will evaluate the effects of daily paraxanthine supplementation on electronic gaming performance, cognitive function, sleep quality, and autonomic responses in healthy adult gamers. Participants will be enrolled in a randomized, double-blind, placebo-controlled, parallel-group study and assigned to receive either paraxanthine or placebo daily for 6 weeks.
Outcome measures will be assessed at baseline, Week 3, and Week 6 and will include electronic gaming performance, cognitive function, visual analog scale ratings, sleep quality questionnaires, hemodynamic responses, and heart rate variability. The study is designed to determine whether paraxanthine supplementation improves performance and selected physiological and psychological outcomes during prolonged electronic gaming sessions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Electronic gaming has grown substantially in popularity, with increasing interest in strategies that may improve performance, cognitive function, sleep quality, and stress management. Despite this growth, there is limited controlled research evaluating nutritional interventions that may influence gaming-specific performance and associated physiological responses.
Paraxanthine is a primary metabolite of caffeine and has been shown to exhibit physiological effects related to alertness, cognitive performance, and central nervous system activity. However, limited research has evaluated the direct effects of paraxanthine supplementation on performance outcomes in electronic gaming environments.
This study is a randomized, double-blind, placebo-controlled, parallel-group trial designed to examine the effects of paraxanthine supplementation on electronic gaming performance and associated cognitive, psychological, and physiological responses. Participants will be assigned to receive paraxanthine or placebo daily for 6 weeks. All participants and study personnel involved in testing and outcome assessment will remain blinded to group assignment throughout the study.
Following screening and informed consent, eligible participants will complete a familiarization session to practice cognitive testing procedures and become oriented to the gaming environment. Participants will complete testing visits at baseline (Week 0), Week 3, and Week 6. Prior to each visit, participants will replicate their dietary intake for 24 hours, maintain their normal caffeine intake pattern, avoid non-habitual stimulants for 48 hours, limit caffeine intake within 3 hours of testing, and complete a 3-hour fast.
At each visit, participants will undergo assessment of body mass, resting heart rate, and blood pressure, followed by completion of sleep questionnaires, cognitive testing, and visual analog scales. After ingestion of the assigned supplement, participants will complete heart rate variability assessment and then perform two standardized 60-minute gaming sessions. Cognitive outcomes, hemodynamic responses, and subjective measures will be reassessed after each gaming period. Heart rate variability will also be assessed following completion of the gaming session.
Electronic gaming performance will be assessed using standardized gameplay metrics collected during each session. Cognitive function will be evaluated using validated neurocognitive tests, and sleep quality will be assessed using standardized questionnaires. Autonomic function will be evaluated using heart rate variability measures.
The primary objective of this study is to determine whether paraxanthine supplementation improves electronic gaming performance, cognitive function, and subjective measures of fatigue, concentration, and focus compared with placebo. Secondary objectives include evaluating the effects of supplementation on sleep quality, heart rate variability, and hemodynamic responses.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Charles, Missouri, United States, 63301
- Lindenwood University Exercise and Performance Nutrition Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 - 40 years of age
- Self-reported to be beginners to gaming or have no experience at all
- Body Mass Index between 18.5 - 29.9 kg/m2
Exclusion Criteria:
- Outside of age range
- Is considered a gamer
- Body mass index is outside of posted inclusion range
- Noncompliance with protocol
- Women who are currently pregnant or are actively planning to become pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo Comparator
Participants assigned to this group will ingest a placebo supplement daily for 6 weeks.
All participants will complete identical testing procedures at baseline (Week 0), Week 3, and Week 6.
|
Participants will ingest a placebo supplement daily for 6 weeks.
The supplement will be consumed with approximately 8 ounces of water at a consistent time each day.
|
|
Experimental: Paraxanthine
Participants assigned to this group will ingest paraxanthine daily for 6 weeks.
All participants will complete identical testing procedures at baseline (Week 0), Week 3, and Week 6.
|
Participants will ingest paraxanthine daily for 6 weeks.
The supplement will be consumed with approximately 8 ounces of water at a consistent time each day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gaming Performance Score
Time Frame: Time Frame: Change from baseline (Week 0) to Week 6
|
Electronic gaming performance will be assessed using standardized gameplay metrics collected during 60- and 120-minute gaming sessions.
Primary variables include knock-outs, falls, damage given, damage taken, hit percentage, and peak damage.
|
Time Frame: Change from baseline (Week 0) to Week 6
|
|
Trail Making Test Part A (Completion Time)
Time Frame: Time Frame: Change from baseline (Week 0) to Week 6
|
Cognitive processing speed and visual attention will be assessed using Trail Making Test Part A, including total time to completion.
|
Time Frame: Change from baseline (Week 0) to Week 6
|
|
Trail Making Test Part B (Completion Time)
Time Frame: Time Frame: Change from baseline (Week 0) to Week 6
|
Cognitive processing speed and visual attention will be assessed using Trail Making Test Part B, including total time to completion.
|
Time Frame: Change from baseline (Week 0) to Week 6
|
|
Trail Making Test Part A (Errors)
Time Frame: Time Frame: Change from baseline (Week 0) to Week 6
|
Cognitive processing speed and visual attention will be assessed using Trail Making Test Part A, including total number of errors.
|
Time Frame: Change from baseline (Week 0) to Week 6
|
|
Trail Making Test Part B (Errors)
Time Frame: Time Frame: Change from baseline (Week 0) to Week 6
|
Cognitive processing speed and visual attention will be assessed using Trail Making Test Part B, including total number of errors.
|
Time Frame: Change from baseline (Week 0) to Week 6
|
|
Stroop Color and Word Test Performance
Time Frame: Time Frame: Change from baseline (Week 0) to Week 6
|
Cognitive performance will be assessed using the Stroop Color and Word Test, including response time and accuracy.
|
Time Frame: Change from baseline (Week 0) to Week 6
|
|
Profile of Mood States (POMS) Total Mood Disturbance Score
Time Frame: Time Frame: Change from baseline (Week 0) to Week 6
|
Mood state will be assessed using the Profile of Mood States questionnaire, with calculation of total mood disturbance score.
|
Time Frame: Change from baseline (Week 0) to Week 6
|
|
Pittsburgh Sleep Quality Index (PSQI) Score
Time Frame: Time Frame: Change from baseline (Week 0) to Week 6
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) global score.
|
Time Frame: Change from baseline (Week 0) to Week 6
|
|
Heart Rate Variability (HRV)
Time Frame: Time Frame: Change from baseline (Week 0) to Week 6
|
Autonomic function will be assessed using heart rate variability metrics including RMSSD, high-frequency power, low-frequency power, and LF:HF ratio.
|
Time Frame: Change from baseline (Week 0) to Week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chad M Kerksick, PhD, Lindenwood University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-62A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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