NCT07533045

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (9)

  • Gaming Performance Score

    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)

    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)

    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)

    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)

    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

    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

    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

    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)

    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

Study Arms (2)

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.

Dietary Supplement: Placebo

Paraxanthine

EXPERIMENTAL

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.

Dietary Supplement: Paraxanthine

Interventions

PlaceboDIETARY_SUPPLEMENT

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.

Placebo Comparator
ParaxanthineDIETARY_SUPPLEMENT

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.

Paraxanthine

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Outside of age range
  • Is considered a gamer
  • Noncompliance with protocol
  • Women who are currently pregnant or are actively planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindenwood University Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Interventions

1,7-dimethylxanthine

Study Officials

  • Chad M Kerksick, PhD

    Lindenwood University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study will employ a double-blind design in which participants, investigators, and study personnel involved in data collection and outcome assessment are blinded to group assignment. Study supplements will be provided in identical capsules and packaging to ensure blinding. Group assignments will be coded and maintained by an independent party not involved in study procedures or data analysis and will remain concealed until completion of data collection and primary analyses.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be randomized to one of two parallel groups to receive either paraxanthine or placebo daily for 6 weeks. All participants will complete identical testing procedures at baseline (Week 0), Week 3, and Week 6.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

June 15, 2021

Primary Completion

April 14, 2025

Study Completion

April 14, 2025

Last Updated

April 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations