Clinical trial NCT03937687: The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine in Law Enforcement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Caffeine, Teacrine, and Dynamine: Effects on Performance
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Compound Solutions Inc.
name: Rutgers, The State University of New Jersey
First posted: 2019-05-06
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between-subjects, three condition groups
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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 63.
* Subject is a current member of the military or law enforcement.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Reaction time
timeFrame: 4 minutes, following the first 30-minute mental fatigue protocol
measure: Reaction time
timeFrame: 4 minutes, following the second 30-minute mental fatigue protocol
measure: Marksmanship
timeFrame: 2 minutes, following the first 30-minute mental fatigue protocol
measure: Marksmanship
timeFrame: 2 minutes, following the second 30-minute mental fatigue protocol
Secondary outcomes:
measure: Blood pressure responses
timeFrame: 3 hours total
measure: Heart rate responses
timeFrame: 3 hours total
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University Center for Health and Human Performance
state: New Jersey
city: Columbia
country: United States
facility: University of South Carolina Sport Science Lab
state: South Carolina
Study officials:
References: