HemodynamicsNCT05715073
Improving Cognition With Neurodegradation Countermeasure
A study testing TeaCrine and Caffeine and Caffeine in people with Hemodynamics and Caffeine, run by University of South Carolina at 1 site in United States.
Trial summary
The goal of this randomized, placebo-controlled, three-condition, double-blind, within-participants crossover clinical trial is to compare caffeine, TeaCrine plus caffeine, and a placebo condition in ROTC or tactical personnel. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamics, Caffeine, TeaCrine
- What is being tested?
- TeaCrine and Caffeine and Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Nov 2023
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is in good health and able to participate in high-intensity exercise.
- Participant is physically active: participating in resistance and/or endurance exercise ≥4 d/wk and ≥150 min/wk for ≥6 mo.
- Participant habitually consumes ≤240 mg caffeine/d (the equivalent of 3 cups of coffee).
- Participants will be asked about dietary supplementation use within the past 6 months.
- (If Participant began taking a supplement within the past month, the Participant will be asked to discontinue supplement use followed by a 2-week washout prior to participation. In all other cases, supplement use will be asked to be maintained throughout the study).
Who cannot join
- Participant currently taking any prescription stimulants (i.e., Adderall, Ritalin, Vyvanse, etc.)
- Participant with any metabolic disorder including known electrolyte abnormalities, diabetes, thyroid disease, adrenal disease or hypogonadism.
- Participant with any inborn error of metabolism.
- Participant with a history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
- Participant with sickle cell trait.
- Participant with a personal history of heart disease, high blood pressure (systolic >140 mm Hg \& diastolic >90 mm Hg), psychiatric disorders, cancer, benign prostate hypertrophy, gastric ulcer, reflux disease, or any other medical condition deemed exclusionary by the medical staff.
Show all 10Show fewer
- Participant currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or anti-coagulant medications.
- Participant who has a known allergy to any of the ingredients in the supplement or the placebo.
- Participant who has migraines.
- Participant with a history of caffeine sensitivity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina Sport Science Lab
Columbia, South Carolina, 29208
About this study
Official title: Improving Neuroprotection, Cognitive Function, and Mental Focus With Neurodegradation Countermeasure
The goal of this randomized, placebo-controlled, three-condition, double-blind, within-participants crossover clinical trial is to compare caffeine, TeaCrine plus caffeine, and a placebo condition in ROTC or tactical personnel.
The main question it aims to answer is the effect of the condition on measures of cognitive performance, cardio-autonomic, and hemodynamic responses after a physically demanding protocol.
Read more
The physiological function will be derived from metrics of heart rate variability, whilst cogntive performance will be evaluated using tasks that assess cognitive domains of executive function, reaction time, and memory.
Participants will report to the lab 4 times, once for familiarization of cognitive measures and then 3 times for their experimental visits. Participants will consume their randomized condition an hour prior to the fatiguing interval exercise protocol. Following they will complete a series of cognitive tasks.
Read the detailed description
The purpose of this randomized, placebo-controlled, three-condition, double-blind, within-participants crossover clinical trial is to determine and compare the effects of the combination of TeaCrine® and caffeine to a placebo and a caffeine condition on measures of cognitive performance, cardio-autonomic, and hemodynamic responses after a physically demanding protocol. After giving informed consent, 20 ROTC members or tactical personnel will undergo baseline performance testing and familiarization and will then be randomly assigned to order of completion of the placebo (P), caffeine (C) condition, and caffeine + TeaCrine (CT) condition, with each session separated by at least 96 hours. In each condition, Participants will be given the condition pill assigned to them, the pill will be taken orally with water, and will wait 60 minutes. At this time, the Participant will complete a treadmill-based physically fatiguing interval protocol with select cognitive testing during the exercise recovery intervals. Participant measures of mental fatigue will be assessed pre- and post-testing, and following the interval bout participants will perform a series of cognitive tasks. Heart rate variability (HRV) and respiration will be assessed continuously though these tasks and blood pressure will be assessed at baseline, prior to the exercise bout, immediately following the exercise bout, and following the cognitive testing.
- Conditions
- Hemodynamics, Caffeine, TeaCrine, Cognitive Change
- Being tested
- TeaCrine and Caffeine, Caffeine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeaCrine and CaffeineDietary supplement
Participants will take Teacrine and caffeine then an hour later perform an intense interval exercise protocol followed by cognitive tests.
CaffeineDietary supplement
Participants will take caffeine then an hour later perform an intense interval exercise protocol followed by cognitive tests.
PlaceboOther
Participants will take the placebo cellulose pill and than an hour later perform an intense interval exercise protocol followed by cognitive tests.
| Study group | Role | What they receive |
|---|---|---|
| TeaCrine and caffeine | Experimental | 150mg of Teacrine and 150mg of caffeine Receives: Dietary Supplement: TeaCrine and Caffeine |
| Caffeine | Active comparator | 300mg of caffeine Receives: Dietary Supplement: Caffeine |
| Placebo | Placebo comparator | 300mg of cellulose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood lactate
Changes in blood lactate across the experimental visit
Measured: On the experimental visit days: Min 0 prior to the exercise protocol, minutes 10, 22, and 30 during the exercise protocol, 5 min after the protocol (min 35), 10 minutes post exercise (min 40)
Changes in Autonomic Nervous System Function (ANS) by linear metrics
To determine if the intervention impacts ANS function by measuring heart rate variability represented by linear time domain metrics.
Measured: On the experimental visit days, this will be measured on a second by second basis from the beginning to the end of the visit (approximately 2 hours)
Changes in Autonomic Nervous System Function (ANS) by nonlinear metrics
To determine if the intervention has an impact on ANS function by measuring heart rate variability represented by nonlinear (ApSaEn) time domain metric.
Measured: On the experimental visit days, this will be measured on a second by second basis from the beginning to the end of the visit (approximately 2 hours)
Changes in Autonomic Nervous System Function (ANS) by frequency domain metrics
To determine if the intervention has an impact on ANS function by measuring heart rate variability represented by frequency domain metrics.
Measured: On the experimental visit days, this will be measured on a second by second basis from the beginning to the end of the visit (approximately 2 hours)
Changes in Inhibitory Control by reaction time (Go/No go)
To determine if the intervention has an impact on inhibitory control by measuring reaction time to Go targets (hits).
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Inhibitory Control by reaction time by errors(Go/No go)
To determine if the intervention has an impact on inhibitory control by measuring errors of commission representing incorrect responses to the target NoGo (false alarm).
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Attention (Go/No go)
To determine if the device has an impact on attention by measuring errors of omission to the target Go (misses).
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Inhibitory Control by accuracy scores (Flanker Task)
To determine if the intervention has an impact on inhibitory control measured by the accuracy scores (% of correct answers) for compatible-congruent, incompatible-congruent, compatible-incongruent, and incompatible-incongruent Flanker Task trials.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Inhibitory Control by average response time (Flanker Task)
To determine if the intervention has an impact on inhibitory control measured by the average response time to incongruent flanker task trials irrespective of compatible or incompatible rule sets.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Inhibitory Control by commission errors (Flanker Task)
- determine if the intervention has an impact on inhibitory control measured by the commission errors when an individual fails to respond correctly to a flanker task trial, and commission error runs when an individual fails to respond correctly to multiple successive trials.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Attention by accuracy (Flanker Task)
To determine if the intervention has an impact on attention measured by the accuracy scores for congruent-compatible Flanker task trials.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Attention by average response time (Flanker Task)
To determine if the intervention has an impact on attention measured by the overall average response time (milliseconds) to compatible and incompatible Flanker task trails irrespective of trial congruency.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Attention by omission errors (Flanker Task)
To determine if the intervention has an impact on attention measured by the omission errors when an individual fails to respond to a flanker task trial, and omission error runs when an individual fails to respond to multiple successive trials.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Cognitive flexibility by accuracy (Flanker Task)
To determine if the intervention has an impact on cognitive flexibility by the accuracy scores for incongruent-incompatible Flanker task trials.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Cognitive flexibility by average response time (Flanker Task)
To determine if the intervention has an impact on cognitive flexibility measured by the average response time to incongruent-incompatible flanker task trials.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Cognitive control by post-error accuracy (Flanker Task)
To determine if the intervention has an impact on cognitive control measured by post-error accuracy on Flanker task trials following an error.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Cognitive control by sequential congruency effect (Flanker Task)
To determine changes in cognitive control measured by sequential congruency effect when lower interference occurs following an incongruent relative to a congruent flanker task trial reflecting a consciously controlled narrowing of attention to the central target.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Cognitive control by inverse efficiency (Flanker Task)
To determine if the intervention has an impact on cognitive control measured by inverse efficiency a metric of a speed-accuracy trade-off for Flanker task trials.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Attentional Inhibition (Flanker Task)
To determine if the intervention has an impact on attentional inhibition measured by congruency interference representing the costs associated with the interference demands associated with incongruent vs congruent flanker task trials.
Measured: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in Rating of Perceived Exertion
To determine if the intervention has an effect on perceived exertion, measured by Borg's Rating of Perceived Exertion scale from 6 to 20. Higher measures indicate more exertion.
Measured: On the experimental visit days: baseline at minute 0, minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
Changes in mood Brunel University Mood Scale (BRUMS).
To determine if the intervention has an effect on mental fatigue and mood.
Measured: On the experimental visit days: baseline at minute 0, immediately after completion of the exercise protocol at approximately 90 minutes into the visit, and 30 minutes after the exercise protocol approximately 120 minutes into the visit
Changes in Object Hit and Avoid
To determine the effects of the intervention on rapid response execution and inhibition during complex continuous task performance.
Measured: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
Changes in Anti-Saccade Task
To determine the effects of the intervention on higher level processes, assessing response inhibition, working memory, and visuospatial attention.
Measured: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
Changes in Modified Trail Making Task
To determine the effects of the intervention on visuomotor processing and executive function.
Measured: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
Changes in 2-Back Task
The determine the effects of the intervention on working memory capacity.
Measured: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Mar 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a crossover intervention, in which participants will partake in all 3 conditions with at least 96 hours of washout between conditions.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn M. Arent, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715073
- Sponsor's protocol ID
- Pro00123869
- Status last verified
- Nov 2023
- First submitted
- 6 Jan 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Neuroprotection, Cognitive Function, and Mental Focus With Neurodegradation Countermeasure
- ClinicalTrials.gov ID
- NCT05715073
- Acronym / sponsor ID
- Pro00123869
- Conditions
- Hemodynamics, Caffeine, TeaCrine, Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 6 Feb 2023 (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 goal of this randomized, placebo-controlled, three-condition, double-blind, within-participants crossover clinical trial is to compare caffeine, TeaCrine plus caffeine, and a placebo condition in ROTC or tactical personnel.
The main question it aims to answer is the effect of the condition on measures of cognitive performance, cardio-autonomic, and hemodynamic responses after a physically demanding protocol.
The physiological function will be derived from metrics of heart rate variability, whilst cogntive performance will be evaluated using tasks that assess cognitive domains of executive function, reaction time, and memory.
Participants will report to the lab 4 times, once for familiarization of cognitive measures and then 3 times for their experimental visits. Participants will consume their randomized condition an hour prior to the fatiguing interval exercise protocol. Following they will complete a series of cognitive tasks.
Detailed description
The purpose of this randomized, placebo-controlled, three-condition, double-blind, within-participants crossover clinical trial is to determine and compare the effects of the combination of TeaCrine® and caffeine to a placebo and a caffeine condition on measures of cognitive performance, cardio-autonomic, and hemodynamic responses after a physically demanding protocol. After giving informed consent, 20 ROTC members or tactical personnel will undergo baseline performance testing and familiarization and will then be randomly assigned to order of completion of the placebo (P), caffeine (C) condition, and caffeine + TeaCrine (CT) condition, with each session separated by at least 96 hours. In each condition, Participants will be given the condition pill assigned to them, the pill will be taken orally with water, and will wait 60 minutes. At this time, the Participant will complete a treadmill-based physically fatiguing interval protocol with select cognitive testing during the exercise recovery intervals. Participant measures of mental fatigue will be assessed pre- and post-testing, and following the interval bout participants will perform a series of cognitive tasks. Heart rate variability (HRV) and respiration will be assessed continuously though these tasks and blood pressure will be assessed at baseline, prior to the exercise bout, immediately following the exercise bout, and following the cognitive testing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a crossover intervention, in which participants will partake in all 3 conditions with at least 96 hours of washout between conditions.
| Arm | Type | Receives |
|---|---|---|
| TeaCrine and caffeine | Experimental | Dietary Supplement: TeaCrine and Caffeine150mg of Teacrine and 150mg of caffeine |
| Caffeine | Active comparator | Dietary Supplement: Caffeine300mg of caffeine |
| Placebo | Placebo comparator | Other: Placebo300mg of cellulose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant is in good health and able to participate in high-intensity exercise.
- Participant is physically active: participating in resistance and/or endurance exercise ≥4 d/wk and ≥150 min/wk for ≥6 mo.
- Participant habitually consumes ≤240 mg caffeine/d (the equivalent of 3 cups of coffee).
- Participants will be asked about dietary supplementation use within the past 6 months.
- (If Participant began taking a supplement within the past month, the Participant will be asked to discontinue supplement use followed by a 2-week washout prior to participation. In all other cases, supplement use will be asked to be maintained throughout the study).
Key exclusion criteria (10 listed)
- Participant currently taking any prescription stimulants (i.e., Adderall, Ritalin, Vyvanse, etc.)
- Participant with any metabolic disorder including known electrolyte abnormalities, diabetes, thyroid disease, adrenal disease or hypogonadism.
- Participant with any inborn error of metabolism.
- Participant with a history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
- Participant with sickle cell trait.
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 |
|---|---|---|
| TeaCrine and CaffeineParticipants will take Teacrine and caffeine then an hour later perform an intense interval exercise protocol followed by cognitive tests. | Dietary supplement | TeaCrine and caffeine |
| CaffeineParticipants will take caffeine then an hour later perform an intense interval exercise protocol followed by cognitive tests. | Dietary supplement | Caffeine |
| PlaceboParticipants will take the placebo cellulose pill and than an hour later perform an intense interval exercise protocol followed by cognitive tests. | Other | Placebo |
Primary outcome
Changes in blood lactate
Time frame: On the experimental visit days: Min 0 prior to the exercise protocol, minutes 10, 22, and 30 during the exercise protocol, 5 min after the protocol (min 35), 10 minutes post exercise (min 40)
Changes in blood lactate across the experimental visit
Changes in Autonomic Nervous System Function (ANS) by linear metrics
Time frame: On the experimental visit days, this will be measured on a second by second basis from the beginning to the end of the visit (approximately 2 hours)
To determine if the intervention impacts ANS function by measuring heart rate variability represented by linear time domain metrics.
Changes in Autonomic Nervous System Function (ANS) by nonlinear metrics
Time frame: On the experimental visit days, this will be measured on a second by second basis from the beginning to the end of the visit (approximately 2 hours)
To determine if the intervention has an impact on ANS function by measuring heart rate variability represented by nonlinear (ApSaEn) time domain metric.
Changes in Autonomic Nervous System Function (ANS) by frequency domain metrics
Time frame: On the experimental visit days, this will be measured on a second by second basis from the beginning to the end of the visit (approximately 2 hours)
To determine if the intervention has an impact on ANS function by measuring heart rate variability represented by frequency domain metrics.
Changes in Inhibitory Control by reaction time (Go/No go)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on inhibitory control by measuring reaction time to Go targets (hits).
Changes in Inhibitory Control by reaction time by errors(Go/No go)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on inhibitory control by measuring errors of commission representing incorrect responses to the target NoGo (false alarm).
Changes in Attention (Go/No go)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the device has an impact on attention by measuring errors of omission to the target Go (misses).
Changes in Inhibitory Control by accuracy scores (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on inhibitory control measured by the accuracy scores (% of correct answers) for compatible-congruent, incompatible-congruent, compatible-incongruent, and incompatible-incongruent Flanker Task trials.
Changes in Inhibitory Control by average response time (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on inhibitory control measured by the average response time to incongruent flanker task trials irrespective of compatible or incompatible rule sets.
Changes in Inhibitory Control by commission errors (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
o determine if the intervention has an impact on inhibitory control measured by the commission errors when an individual fails to respond correctly to a flanker task trial, and commission error runs when an individual fails to respond correctly to multiple successive trials.
Changes in Attention by accuracy (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on attention measured by the accuracy scores for congruent-compatible Flanker task trials.
Changes in Attention by average response time (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on attention measured by the overall average response time (milliseconds) to compatible and incompatible Flanker task trails irrespective of trial congruency.
Changes in Attention by omission errors (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on attention measured by the omission errors when an individual fails to respond to a flanker task trial, and omission error runs when an individual fails to respond to multiple successive trials.
Changes in Cognitive flexibility by accuracy (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on cognitive flexibility by the accuracy scores for incongruent-incompatible Flanker task trials.
Changes in Cognitive flexibility by average response time (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on cognitive flexibility measured by the average response time to incongruent-incompatible flanker task trials.
Changes in Cognitive control by post-error accuracy (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on cognitive control measured by post-error accuracy on Flanker task trials following an error.
Changes in Cognitive control by sequential congruency effect (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine changes in cognitive control measured by sequential congruency effect when lower interference occurs following an incongruent relative to a congruent flanker task trial reflecting a consciously controlled narrowing of attention to the central target.
Changes in Cognitive control by inverse efficiency (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on cognitive control measured by inverse efficiency a metric of a speed-accuracy trade-off for Flanker task trials.
Changes in Attentional Inhibition (Flanker Task)
Time frame: On the experimental visit days: minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an impact on attentional inhibition measured by congruency interference representing the costs associated with the interference demands associated with incongruent vs congruent flanker task trials.
Changes in Rating of Perceived Exertion
Time frame: On the experimental visit days: baseline at minute 0, minutes 10, 22, and 30 during the exercise protocol, and 30 minutes after the exercise protocol
To determine if the intervention has an effect on perceived exertion, measured by Borg's Rating of Perceived Exertion scale from 6 to 20. Higher measures indicate more exertion.
Changes in mood Brunel University Mood Scale (BRUMS).
Time frame: On the experimental visit days: baseline at minute 0, immediately after completion of the exercise protocol at approximately 90 minutes into the visit, and 30 minutes after the exercise protocol approximately 120 minutes into the visit
To determine if the intervention has an effect on mental fatigue and mood.
Changes in Object Hit and Avoid
Time frame: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
To determine the effects of the intervention on rapid response execution and inhibition during complex continuous task performance.
Changes in Anti-Saccade Task
Time frame: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
To determine the effects of the intervention on higher level processes, assessing response inhibition, working memory, and visuospatial attention.
Changes in Modified Trail Making Task
Time frame: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
To determine the effects of the intervention on visuomotor processing and executive function.
Changes in 2-Back Task
Time frame: On the experimental visit days: Immediately after and 30 minutes after the completion of the exercise protocol.
The determine the effects of the intervention on working memory capacity.
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 29 Nov 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeaCrine and Caffeine and Caffeine in people with Hemodynamics and Caffeine, run by University of South Carolina at 1 site 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 5 inclusion and 10 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Changes in blood lactate (time frame: On the experimental visit days: Min 0 prior to the exercise protocol, minutes 10, 22, and 30 during the exercise protocol, 5 min after the protocol (min 35), 10 minutes post exercise (min 40)). The study lists 25 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 29 Nov 2023.