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临床试验/NCT03937687
NCT03937687已完成早期 1 期

The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine on Marksmanship Accuracy and Reaction Time in ROTC Members, Military, and Law Enforcement Following a Mentally Fatiguing Protocol

University of South Carolina2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2019年5月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
49
试验地点
2
主要终点
Reaction time

研究概览

简要总结

The purpose of this randomized, placebo-controlled, three-condition, double-blind, between-subjects clinical trial is to determine and compare the effects of the combination of TeaCrine®, Dynamine, and caffeine to a placebo and caffeine condition on reaction time and target acquisition and accuracy. A secondary purpose is to observe the changes in hemodynamic variables in response to this combination.

详细描述

BASELINE ASSESSMENT:

  • Subjects will report to the University of South Carolina Sport Science Lab normally hydrated and having refrained from eating for minimum 2 hours prior.
  • Upon arrival, subjects will complete the informed consent and the Caffeine Frequency Questionnaire (CFQ) to assess their intake.
  • Subjects will have body composition assessed using air displacement plethysmography (Bod Pod, Cosmed, Inc.) using standardized procedures.
  • A salivary sample will be provided by each subject before beginning familiarization to analyze for presence of the CYP1A2 (caffeine) gene.
  • Subjects will be familiarized with the cognitive testing protocols using the Dynavision D2TM board and TRAZER Sports Simulator. They will complete a shortened version of the mentally fatiguing condition on the DynavisionTM to familiarize with the protocol. They will be able to complete 3 trials of reaction time using the simulation on the TRAZER.
  • Following this, subjects will then complete 3 trials of marksmanship assessment using the optical targetry system.

CONDITIONS:

  • Following exercise familiarization, subjects will be randomly assigned to the condition of placebo (P), caffeine (C), or combination of caffeine + TeaCrine + Dynamine (DC). Sessions will be scheduled at the same time as the initial baseline/familiarization session.
  • Subjects will be asked to maintain a normal sleep schedule in the week leading up to their session, maintaining the same wake time each day.
  • Subjects will be asked to refrain from alcohol for 48 hours and caffeine 24 hours prior to their condition, with no major changes in food intake.
  • Subjects will consume the supplement, complete the Multi-Component Training Distress Scale (MTDS) and will begin their session 30 minutes later.
  • Sessions will include 30 minutes of a mentally fatiguing task on the Dynavision D2TM board, designed with a go/no-go stimulus. The blinds will be drawn and lights switched off to reduce glare on the board.
  • At baseline and after each phase of the protocol, an assessment of psychological arousal will be taken using subjective measures of the Felt Arousal Scale (FAS) .
  • Subjects will then perform the reaction time assessment on the TRAZER and shooting assessment. This will be performed twice. The TRAZER will consist of 40 targets, and the shooting assessment will be 8 shots with a tactical re-load followed by an additional 8 shots. A 2-minute rest will be taken between trials. Total time allotted for assessments will be 20 minutes.
  • Subjects will then be seated in a room for 30 minutes, during which time they will read leisurely. At the completion of this time, subjects will complete the mentally fatiguing protocol once more (30 minutes). Following this, measures of reaction time and shooting assessment will be performed again (20 minutes).
  • Heart rate will be monitored and recorded throughout testing to establish average and peak values during the reaction time and marksmanship tasks.
  • Blood pressure will be measured pre- and post-testing using the Omron HEM 907XL Intellisense Pro Digital Blood Pressure cuff.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double-blind

入排标准

年龄范围
18 Years 至 63 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Subject has provided written and dated informed consent to participate in the study.
  • Subject is in good health as determined by physical examination and medical history.
  • Subject is between the ages of 18 and
  • Subject is a current member of the military or law enforcement.

排除标准

  • Subjects who have injuries that would prevent them from completing the protocol.
  • Subjects who have migraine headaches.
  • Subjects with a history of kidney or liver disease.
  • Subjects with a history of caffeine sensitivity.
  • Subjects currently taking OTC products containing pseudoephedrine or other stimulants.
  • Subjects who drink more than four cups of coffee per day.

研究组 & 干预措施

Placebo

Placebo Comparator

300 mg cellulose

干预措施: Placebo (Drug)

Caffeine

Experimental

300 mg caffeine

干预措施: Caffeine (Drug)

Caffeine Combination

Experimental

150 mg caffeine with 100 mg Dynamine and 50 mg TeaCrine

干预措施: Caffeine+TeaCrine+Dynamine (Drug)

结局指标

主要结局

Reaction time

时间窗: 4 minutes, following the second 30-minute mental fatigue protocol

Spatial reaction

Marksmanship

时间窗: 2 minutes, following the second 30-minute mental fatigue protocol

Simulated marksmanship using optical targetry

次要结局

  • Blood pressure responses(3 hours total)
  • Heart rate responses(3 hours total)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shawn M. Arent

Principal Investigator

University of South Carolina

研究点 (2)

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