- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07533032
Dose-Response Effect of Phosphatidylserine on eSport Performance (EPS)
This study will evaluate the effects of daily phosphatidylserine supplementation on electronic gaming performance, cognitive function, sleep quality, stress-related outcomes, 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 placebo, 100 mg phosphatidylserine, or 200 mg phosphatidylserine 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 daily phosphatidylserine supplementation can improve performance and selected physiological and psychological outcomes during prolonged electronic gaming sessions.
Study Overview
Status
Conditions
Detailed Description
Electronic gaming has grown substantially in popularity, with increasing interest in nutritional strategies that may improve gaming performance, cognitive function, sleep quality, and stress management. Phosphatidylserine is a phospholipid commonly derived from soy that is highly concentrated in neural tissue and has been investigated for its potential effects on cognition, stress-related responses, and mental performance. Despite growing interest in nutritional support for gamers, limited controlled research has evaluated the effects of supplementation on gaming-specific performance and related physiological outcomes.
This study is a randomized, double-blind, placebo-controlled, parallel-group trial designed to examine the effects of phosphatidylserine supplementation on electronic gaming performance and associated cognitive, psychological, and physiological responses. Participants will be assigned to receive placebo, 100 mg phosphatidylserine, or 200 mg phosphatidylserine daily for 6 weeks. All participants and study personnel involved in testing and outcome assessment will remain blinded to treatment assignment throughout the study.
Following screening and informed consent, eligible participants will complete a familiarization session during which they will practice the cognitive tests and become oriented to the gaming environment and procedures. Participants will then complete testing visits at baseline, Week 3, and Week 6. Prior to each testing visit, participants will be instructed to replicate their dietary intake for the preceding 24 hours, maintain their normal caffeine intake pattern, refrain from other stimulants not commonly consumed in their diet for 48 hours, avoid caffeine doses greater than 100 mg within 3 hours of testing, and complete a 3-hour fast before arrival.
At each testing visit, body mass, resting heart rate, and resting blood pressure will be assessed. Participants will then complete sleep-related questionnaires, cognitive testing, and visual analog scales assessing fatigue, concentration, and focus. After ingestion of the assigned supplement dose, participants will undergo heart rate variability assessment and then complete two 60-minute electronic gaming sessions separated by interim testing. Hemodynamic responses, cognitive outcomes, and visual analog scale ratings will be reassessed after 60 minutes and again after 120 minutes of gaming. Heart rate variability will also be assessed following completion of the gaming session.
Electronic gaming performance will be assessed using a standardized video game protocol with predefined performance metrics recorded after each gaming period. Cognitive outcomes will include the Stroop Color and Word Test, Trail Making Test Parts A and B, and Profile of Mood States. Sleep-related outcomes will be assessed using validated questionnaires, and autonomic function will be evaluated using heart rate variability metrics. Hemodynamic responses will include heart rate and blood pressure measured under standardized conditions.
The primary objective of the study is to determine whether 6 weeks of phosphatidylserine supplementation improves electronic gaming performance, cognitive function, and subjective ratings related to 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
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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: Phosphatidylserine (100 mg)
Participants assigned to this group will ingest 100 mg of phosphatidylserine daily for 6 weeks.
All participants will complete identical testing procedures at baseline (Week 0), Week 3, and Week 6.
|
Participants will ingest 100 mg of phosphatidylserine daily for 6 weeks.
The supplement will be consumed with approximately 8 ounces of water at a consistent time each day.
|
|
Experimental: Phosphatidylserine (200 mg)
Participants assigned to this group will ingest 200 mg of phosphatidylserine daily for 6 weeks.
All participants will complete identical testing procedures at baseline (Week 0), Week 3, and Week 6.
|
Participants will ingest 200 mg of phosphatidylserine 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: 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.
|
Change from baseline (Week 0) to Week 6
|
|
Trail Making Test Part A (Completion Time)
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.
|
Change from baseline (Week 0) to Week 6
|
|
Trail Making Test Part B (Completion Time)
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.
|
Change from baseline (Week 0) to Week 6
|
|
Trail Making Test Part A (Errors)
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.
|
Change from baseline (Week 0) to Week 6
|
|
Trail Making Test Part B (Errors)
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.
|
Change from baseline (Week 0) to Week 6
|
|
Stroop Color and Word Test Performance
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.
|
Change from baseline (Week 0) to Week 6
|
|
Profile of Mood States (POMS) Total Mood Disturbance Score
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.
|
Change from baseline (Week 0) to Week 6
|
|
Pittsburgh Sleep Quality Index (PSQI) Score
Time Frame: Change from baseline (Week 0) to Week 6
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) global score.
|
Change from baseline (Week 0) to Week 6
|
|
Heart Rate Variability (HRV)
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.
|
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
- 21-62
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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