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临床试验/NCT07533032
NCT07533032已完成不适用

Dose-Response Effect of Phosphatidylserine on eSport Performance

Lindenwood University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Gaming Performance Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Placebo (Dietary Supplement)

Phosphatidylserine (100 mg)

Experimental

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.

干预措施: Phosphatidylserine (100 mg) (Dietary Supplement)

Phosphatidylserine (200 mg)

Experimental

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.

干预措施: Phosphatidylserine (200 mg) (Dietary Supplement)

结局指标

主要结局

Gaming Performance Score

时间窗: 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.

Trail Making Test Part A (Completion Time)

时间窗: 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.

Trail Making Test Part B (Completion Time)

时间窗: 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.

Trail Making Test Part A (Errors)

时间窗: 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.

Trail Making Test Part B (Errors)

时间窗: 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.

Stroop Color and Word Test Performance

时间窗: 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.

Profile of Mood States (POMS) Total Mood Disturbance Score

时间窗: 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.

Pittsburgh Sleep Quality Index (PSQI) Score

时间窗: Change from baseline (Week 0) to Week 6

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) global score.

Heart Rate Variability (HRV)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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