The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine in Law Enforcement
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|ClinicalTrials.gov Identifier: NCT03937687|
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Caffeine, Teacrine, and Dynamine: Effects on Performance||Drug: Caffeine+TeaCrine+Dynamine Drug: Placebo Drug: Caffeine||Early Phase 1|
- Subjects will report to the Rutgers Center for Health & Human Performance 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Between-subjects, three condition groups|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||May 4, 2019|
|Estimated Primary Completion Date :||February 15, 2020|
|Estimated Study Completion Date :||March 1, 2020|
Placebo Comparator: Placebo
300 mg cellulose
300 mg caffeine
Experimental: Caffeine Combination
150 mg caffeine with 100 mg Dynamine and 50 mg TeaCrine
combination of caffeine, TeaCrine, and Dynamine
Other Name: Combination
- Reaction time [ Time Frame: 4 minutes, following the first 30-minute mental fatigue protocol ]Spatial reaction
- Reaction time [ Time Frame: 4 minutes, following the second 30-minute mental fatigue protocol ]Spatial reaction
- Marksmanship [ Time Frame: 2 minutes, following the first 30-minute mental fatigue protocol ]Simulated marksmanship using optical targetry
- Marksmanship [ Time Frame: 2 minutes, following the second 30-minute mental fatigue protocol ]Simulated marksmanship using optical targetry
- Blood pressure responses [ Time Frame: 3 hours total ]Changes in blood pressure throughout the course of the protocol
- Heart rate responses [ Time Frame: 3 hours total ]Changes in heart rate throughout the course the protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937687
|Contact: Shawn Arent, PhDfirstname.lastname@example.org|
|Contact: Marissa Bello, MSemail@example.com|
|United States, New Jersey|
|Rutgers Center for Health and Human Performance||Recruiting|
|New Brunswick, New Jersey, United States, 08901|
|Contact: Shawn Arent, PhD 848-932-7050 firstname.lastname@example.org|
|Contact: Marissa Bello, MS 8624321012 email@example.com|