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出境医 / 临床实验 / The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine in Law Enforcement
The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine in Law Enforcement
Study Description
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 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.
Study Design
| 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 |
| Actual Study Start Date : | May 4, 2019 |
| Estimated Primary Completion Date : | May 31, 2021 |
| Estimated Study Completion Date : | November 1, 2021 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Eligibility Criteria
| 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.
Contacts and Locations
Contacts
| Contact: Shawn M. Arent, PhD | (803) 576-8394 | sarent@mailbox.sc.edu | |
| Contact: Harry P. Cintineo, MS | (201) 527-0839 | cintineo@email.sc.edu |
Locations
| United States, New Jersey | |
| Rutgers University Center for Health and Human Performance | Terminated |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, South Carolina | |
| University of South Carolina Sport Science Lab | Recruiting |
| Columbia, South Carolina, United States, 29208 | |
| Contact: Shawn M. Arent, PhD 803-576-8394 sarent@mailbox.sc.edu | |
| Contact: Harry P. Cintineo, MS (201) 527-0839 cintineo@email.sc.edu | |
Sponsors and Collaborators
University of South Carolina
Compound Solutions Inc.
Rutgers, The State University of New Jersey
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 26, 2019 | ||||||||
| First Posted Date ICMJE | May 6, 2019 | ||||||||
| Last Update Posted Date | April 28, 2021 | ||||||||
| Actual Study Start Date ICMJE | May 4, 2019 | ||||||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine in Law Enforcement | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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:
CONDITIONS:
|
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Early Phase 1 | ||||||||
| Study Design ICMJE | 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
|
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| Condition ICMJE | Caffeine, Teacrine, and Dynamine: Effects on Performance | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
54 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | November 1, 2021 | ||||||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 63 Years (Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03937687 | ||||||||
| Other Study ID Numbers ICMJE | Pro00096559 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Shawn M. Arent, University of South Carolina | ||||||||
| Study Sponsor ICMJE | University of South Carolina | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | University of South Carolina | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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