The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine in Law Enforcement
Condition: Caffeine, Teacrine, and Dynamine: Effects on Performance
Study type: Interventional
Phase: Early Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Caffeine+TeaCrine+Dynamine; Placebo; Caffeine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): combination of caffeine, TeaCrine, and Dynamine; Placebo; Caffeine
Other intervention name(s): Combination
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between-subjects, three condition groups
Masking: Double (Participant, Investigator)
Primary purpose: Treatment