Caffeine, Teacrine, and Dynamine: Effects on PerformanceEarly Phase 1NCT03937687
The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine in Law Enforcement
A Early Phase 1 study testing Caffeine+TeaCrine+Dynamine and Caffeine in people with Caffeine, Teacrine, and Dynamine: Effects on Performance, run by University of South Carolina at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 63 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Caffeine, Teacrine, and Dynamine: Effects on Performance
- What is being tested?
- Caffeine+TeaCrine+Dynamine and Caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 May 2019to 15 Nov 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 63 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of South Carolina Sport Science Lab
Columbia, South Carolina, 29208
Rutgers University Center for Health and Human Performance
New Brunswick, New Jersey, 08901
About this study
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
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.
Read the 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.
- Being tested
- Caffeine+TeaCrine+Dynamine, Placebo, Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine+TeaCrine+DynamineDrug
Also called Combination
combination of caffeine, TeaCrine, and Dynamine
PlaceboDrug
Placebo
CaffeineDrug
Caffeine
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 300 mg cellulose Receives: Drug: Placebo |
| Caffeine | Experimental | 300 mg caffeine Receives: Drug: Caffeine |
| Caffeine Combination | Experimental | 150 mg caffeine with 100 mg Dynamine and 50 mg TeaCrine Receives: Drug: Caffeine+TeaCrine+Dynamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time
Spatial reaction
Measured: 4 minutes, following the first 30-minute mental fatigue protocol
Reaction time
Spatial reaction
Measured: 4 minutes, following the second 30-minute mental fatigue protocol
Marksmanship
Simulated marksmanship using optical targetry
Measured: 2 minutes, following the first 30-minute mental fatigue protocol
Marksmanship
Simulated marksmanship using optical targetry
Measured: 2 minutes, following the second 30-minute mental fatigue protocol
Secondary outcomes (2)
Blood pressure responses
Changes in blood pressure throughout the course of the protocol
Measured: 3 hours total
Heart rate responses
Changes in heart rate throughout the course the protocol
Measured: 3 hours total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start4 May 2019
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caffeine, Teacrine, and Dynamine: Effects on PerformanceStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between-subjects, three condition groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Compound Solutions Inc., Rutgers, The State University of New Jersey
- Responsible party
- Principal investigator, Shawn M. Arent, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937687
- Sponsor's protocol ID
- Pro00096559
- Status last verified
- Sep 2021
- First submitted
- 26 Apr 2019
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03937687
- Acronym / sponsor ID
- Pro00096559
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Compound Solutions Inc., Rutgers, The State University of New Jersey
- Study start
- 4 May 2019 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Between-subjects, three condition groups
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo300 mg cellulose |
| Caffeine | Experimental | Drug: Caffeine300 mg caffeine |
| Caffeine Combination | Experimental | Drug: Caffeine+TeaCrine+Dynamine150 mg caffeine with 100 mg Dynamine and 50 mg TeaCrine |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine+TeaCrine+DynamineAlso: Combinationcombination of caffeine, TeaCrine, and Dynamine | Drug | Caffeine Combination |
| PlaceboPlacebo | Drug | Placebo |
| CaffeineCaffeine | Drug | Caffeine |
Primary outcome
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
2 secondary outcomes
Blood pressure responses
Time frame: 3 hours total
Heart rate responses
Time frame: 3 hours total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Caffeine+TeaCrine+Dynamine and Caffeine in people with Caffeine, Teacrine, and Dynamine: Effects on Performance, run by University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time (time frame: 4 minutes, following the first 30-minute mental fatigue protocol). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.