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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 : May 6, 2019
Sponsor:
Collaborator:
Compound Solutions Inc.
Information provided by (Responsible Party):
Shawn M. Arent, PhD, CSCS*D, FISSN, FACSM, Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Caffeine, Teacrine, and Dynamine: Effects on Performance Drug: Caffeine+TeaCrine+Dynamine Drug: Placebo Drug: Caffeine Early Phase 1

Detailed Description:

BASELINE ASSESSMENT:

  • 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Between-subjects, three condition groups
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
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
Estimated Study Start Date : April 23, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Placebo Comparator: Placebo
300 mg cellulose
Drug: Placebo
Placebo

Experimental: Caffeine
300 mg caffeine
Drug: Caffeine
Caffeine

Experimental: Caffeine Combination
150 mg caffeine with 100 mg Dynamine and 50 mg TeaCrine
Drug: Caffeine+TeaCrine+Dynamine
combination of caffeine, TeaCrine, and Dynamine
Other Name: Combination




Primary Outcome Measures :
  1. Reaction time [ Time Frame: 4 minutes, following the first 30-minute mental fatigue protocol ]
    Spatial reaction

  2. Reaction time [ Time Frame: 4 minutes, following the second 30-minute mental fatigue protocol ]
    Spatial reaction

  3. Marksmanship [ Time Frame: 2 minutes, following the first 30-minute mental fatigue protocol ]
    Simulated marksmanship using optical targetry

  4. Marksmanship [ Time Frame: 2 minutes, following the second 30-minute mental fatigue protocol ]
    Simulated marksmanship using optical targetry


Secondary Outcome Measures :
  1. Blood pressure responses [ Time Frame: 3 hours total ]
    Changes in blood pressure throughout the course of the protocol

  2. Heart rate responses [ Time Frame: 3 hours total ]
    Changes in heart rate throughout the course the protocol



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Ages Eligible for Study:   18 Years to 63 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Shawn Arent, PhD 8489327050 shawn.arent@rutgers.edu
Contact: Marissa Bello, MS 8624321012 mb1527@scarletmail.rutgers.edu

Locations
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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    shawn.arent@rutgers.edu   
Contact: Marissa Bello, MS    8624321012    mb1527@scarletmail.rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Compound Solutions Inc.

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Responsible Party: Shawn M. Arent, PhD, CSCS*D, FISSN, FACSM, Principal Investigator, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03937687     History of Changes
Other Study ID Numbers: Pro2017000028
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents