Physiological StressNCT05592561
Impact of Supplements on Stress Markers
A study testing mental stress task in people with Physiological Stress, run by Texas State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine the effects of caffeine, theanine and tyrosine ingestion on markers of stress in healthy college aged individuals that are exposed to a mental stress task. The main questions to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress
- What is being tested?
- mental stress task
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to 10 Apr 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- apparently healthy, aged 18-40,
- free from any known cardiovascular or metabolic diseases,
- free from any major stressors within the last 30 days such as birth of a child, abortion, or divorce.
Who cannot join
- subjects are required to not have a history of motion sickness or vertigo,
- not previously diagnosed with a brain injury or epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Caffeine, Theanine, Tyrosine Ingestion on Markers of Stress in Response to a Cognitive Challenge and Virtual Reality Active Shooter Drill
The goal of this clinical trial is to examine the effects of caffeine, theanine and tyrosine ingestion on markers of stress in healthy college aged individuals that are exposed to a mental stress task. The main questions to answer are:
- what is the impact of a mental stress task involving a cognitive challenge and virtual reality based active shooter scenario on markers of subjective and biological stress?
- what is the impact of supplement ingestion (caffeine, theanine, tyrosine, analyzed separately) 40 min prior to exposure to the mental stress task?
Read the detailed description
This study will take place in two blocks of randomization, where during the first segment of randomization, participants will be randomly assigned to ingest either 200mg of caffeine powder or a placebo beverage (0mg caffeine) which will be flavored and sweetened with crystal light powder. Ingestion takes place 40 min prior to engaging in a mental stress task which included a cognitive challenge and a virtual reality based active shooter drill. Researchers will compare the two treatment groups in terms of changes in heart rate, subjective stress, and salivary markers of stress before and after the mental stress task.
During the second block of randomization, subjects will be randomly assigned to ingest either 200 mg of theanine powder or 2000 mg of tyrosine powder with crystal light powder, mixed with water, also 40 min prior to the same mental stress task. The placebo condition from the first block of randomization will be used as a control for comparison for all three supplements. The experimental procedures are the same for all four treatments (placebo, caffeine, tyrosine, theanine) and only differ with respect to which beverage was ingested prior to the mental stress task.
All procedures were reviewed and approved by the University Institutional Review Board.
Experimental Procedures Upon arrival to the testing site, body mass will be measured using a digital scale (Rice Lake Weighing Systems, Rice Lake, WI, USA), and height will be measured using a portable stadiometer (213; SECA, CA, USA). Subjects will be then instructed to rinse their mouth with water and rest in a quiet room for 10 minutes. During this time, they will be equipped with a heart rate (HR) monitor (Polar verity sense; Polar Electro Ltd, Kempele, Finland). Immediately after the 10 minute rest period, an initial saliva sample, HR and SAI measures were collected (45 min prior to mental stress task). Five min after this (40 min pre mental stress task), subjects will consume their assigned treatment: either the placebo (crystal light + 8 oz of water) or caffeine supplement (200 mg caffeine + crystal light + 8 oz of water ). Throughout the experimental session, HR, SAI, and saliva samples will be collected a total of four times: 1) 45 minutes prior to the start of the mental stress task, 2) immediately before the mental stress task, 3) immediately after the mental stress task, and 4) 30 min after the mental stress task.
Mental Stress Task: Cognitive Challenge \& VR-ASD The stress protocol used for this experiment will utilize a cognitive challenge and a previously studied VR-ASD. The cognitive challenge will include a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). Immediately upon completion of the cognitive challenge, the subjects will complete the VR-ASD scenario (~2 min) followed by the same cognitive challenge with different questions (another 4 min). The total duration was ~10 min.
Stroop Challenge For the Stroop challenge, the subjects will be presented with a 0.5 second display of a word on the computer screen (i.e., yellow, green, red, or blue). However, the word is written in conflicting-color font presenting a mental conflict. Subjects are required to identify the text font color as quickly as possible using a color-coded keypad. Note, 0.5 seconds was allowed for the response. Feedback included total attempts, total correct and incorrect responses, missed responses, and response time.
Arithmetic Calculations The arithmetic calculations consisted of addition and subtraction with single, double-, and triple-digit numbers (e.g., 736 minus 58). The subject was given 10 seconds to respond to each mathematical question. Failure to respond within the allotted time resulted in an incorrect response. The subjects were presented with 2-min of the Stroop Challenge followed by 2-min of mental arithmetic. This will occur both before and after the VR-ASD.
Virtual Reality Active Shooter Drill The general procedures for the VR-ASD are previously described and based on a live -action ASD protocol (McAllister et. al., 2020). Briefly, the subject advanced down a ~3-meter-long hallway where two wounded victims were encountered. A white female victim with traumatic injuries was laying on the ground while an African American female victim "ran" out of a classroom with a gunshot wound to the left arm and leg. Upon arriving to the classroom, the subject observed a white female on the ground with a traumatic head injury as well as the shooter (white male) firing a handgun at an African American male. The subject was required to fire his/her weapon to prevent the shooter from turning toward the subject and eliciting a response. Once the shooter fell down after being shot by the subject, the VR-ASD scenario ended. The VR-ASD was presented using HTC VIVE Pro VR equipment (HTC Corp, New Taipei, Taiwan). The VR laboratory environment is larger than the virtual environment (~35 ft x 20 ft); therefore, subjects are able to physical maneuver throughout the ASD without disruption.
Supplement Ingestion Caffeine supplement capsules containing 200 mg caffeine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada)will be used for the present study. The capsules will be broken into halves and the caffeine powder inside was mixed with 8 oz of water and calorie free crystal light. For the placebo treatment, the same flavor of crystal light will be mixed with 8 oz of water.add that the treatments were flavor/sweetness matched.
For the theanine treatment, 200mg pure theanine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada) will be mixed with 8 oz water and crystal light
for the tyrosine treatment, 2000mg of tyrosine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada) will be mixed with 8oz of water and crystal light.
- Conditions
- Physiological Stress
- Being tested
- mental stress task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mental stress taskOther
The stress protocol used for this experiment utilized a cognitive challenge and a previously studied virtual reality active shooter drill (VR-ASD). The cognitive challenge included a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). Immediately upon completion of the cognitive challenge, the subjects completed the VR-ASD scenario (~2 min) followed by the same cognitive challenge with different questions (another 4 min). The total duration was ~10 min.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine group | Experimental | Subjects will receive 200 mg of caffeine powder which was obtained from a 200 mg capsule (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada). Researchers will break open the capsule and mix with water and 5/8 tsp of crystal light immediately before subjects ingest the randomly assigned treatment. Receives: Other: mental stress task |
| Placebo | Placebo comparator | flavored water (sweetened with crystal light powder, 0.5 tsp) will be provided to subjects without any caffeine powder added. Receives: Other: mental stress task |
| Theanine group | Experimental | 200mg pure theanine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada) + 8 oz water+ 0.55 tsp crystal light will be ingested. Receives: Other: mental stress task |
| Tyrosine group | Experimental | 2000 mg pure tyrosine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada) +8 oz water + 0.5 tsp crystal light will be ingested. Receives: Other: mental stress task |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary secretory IgA
SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress
Measured: Up to 10 months
salivary alpha amylase
salivary alpha amylase is an enzyme involved in digestive processes. amylase concentrations in saliva have been shown to reflect sympathetic stress. Thus, as sympathetic stress increases, salivary alpha amylase concentrations tend to increase
Measured: Up to 10 months
salivary cortisol
salivary cortisol is a marker of stress which reflects activation of the hypothalamic pituitary adrenal axis.
Measured: Up to 10 months
heart rate
heart rate reflects activity from the parasympathetic and sympathetic nervous system and increases when exposed to stress
Measured: Up to 10 months
State anxiety inventory
state anxiety inventory is a subjective scale which includes six short statements such as "I feel calm" or " I feel tense" and composite scores of participant responses are used for analysis. Higher values reflect higher subjective anxiety.
Measured: Up to 10 months
Secondary outcomes (6)
mental arithmetic incorrect
The cognitive challenge included a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). The software included number of correct, incorrect, missed responses and response time.
Measured: Up to 10 months
mental arithmetic missed responses
The cognitive challenge included a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). The software included number of correct, incorrect, missed responses and response time.
Measured: Up to 10 months
mental arithmetic response time
The cognitive challenge included a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). The software included number of correct, incorrect, missed responses and response time.
Measured: Up to 10 months
Stroop challenge number of incorrect
The cognitive challenge included a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). The software included number of correct, incorrect, missed responses and response time.
Measured: Up to 10 months
Stroop challenge number of missed responses
The cognitive challenge included a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). The software included number of correct, incorrect, missed responses and response time.
Measured: Up to 10 months
Stroop challenge response time
The cognitive challenge included a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). The software included number of correct, incorrect, missed responses and response time.
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start25 Jan 2022
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physiological StressStudies 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
- Parallel groups
- Model description
- Subjects will be randomly assigned to one of four treatments: 1. placebo ingestion 2. caffeine ingestion 3. theanine ingestion 4. tyrosine ingestion nutrient ingestion takes place 40 min prior to being exposed to a mental stress task.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Collaborators
- M. Hunter Martaindale, C. Dillard, D. Gonzalez
- Responsible party
- Principal investigator, Matt McAllister, Texas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592561
- Sponsor's protocol ID
- Supplements and VR-ASD
- Status last verified
- Apr 2023
- First submitted
- 18 Oct 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McAllister MJ, Martaindale MH, Dillard CC, McCullough R. Impact of L-theanine and L-tyrosine on markers of stress and cognitive performance in response to a virtual reality based active shooter training drill. Stress. 2024 Jan;27(1):2375588. doi: 10.1080/10253890.2024.2375588. Epub 2024 Jul 8.
PubMed 38975711McAllister MJ, Martaindale MH, Dillard CC, Gonzalez DE. Stress response to virtual reality based active shooter training: Impact of caffeine consumption. Psychoneuroendocrinology. 2024 Mar;161:106923. doi: 10.1016/j.psyneuen.2023.106923. Epub 2023 Dec 7.
PubMed 38142605
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Caffeine, Theanine, Tyrosine Ingestion on Markers of Stress in Response to a Cognitive Challenge and Virtual Reality Active Shooter Drill
- ClinicalTrials.gov ID
- NCT05592561
- Acronym / sponsor ID
- Supplements and VR-ASD
- Conditions
- Physiological Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Collaborators
- M. Hunter Martaindale, C. Dillard, D. Gonzalez
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 24 Oct 2022 (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 clinical trial is to examine the effects of caffeine, theanine and tyrosine ingestion on markers of stress in healthy college aged individuals that are exposed to a mental stress task. The main questions to answer are:
- what is the impact of a mental stress task involving a cognitive challenge and virtual reality based active shooter scenario on markers of subjective and biological stress?
- what is the impact of supplement ingestion (caffeine, theanine, tyrosine, analyzed separately) 40 min prior to exposure to the mental stress task?
Detailed description
This study will take place in two blocks of randomization, where during the first segment of randomization, participants will be randomly assigned to ingest either 200mg of caffeine powder or a placebo beverage (0mg caffeine) which will be flavored and sweetened with crystal light powder. Ingestion takes place 40 min prior to engaging in a mental stress task which included a cognitive challenge and a virtual reality based active shooter drill. Researchers will compare the two treatment groups in terms of changes in heart rate, subjective stress, and salivary markers of stress before and after the mental stress task.
During the second block of randomization, subjects will be randomly assigned to ingest either 200 mg of theanine powder or 2000 mg of tyrosine powder with crystal light powder, mixed with water, also 40 min prior to the same mental stress task. The placebo condition from the first block of randomization will be used as a control for comparison for all three supplements. The experimental procedures are the same for all four treatments (placebo, caffeine, tyrosine, theanine) and only differ with respect to which beverage was ingested prior to the mental stress task.
All procedures were reviewed and approved by the University Institutional Review Board.
Experimental Procedures Upon arrival to the testing site, body mass will be measured using a digital scale (Rice Lake Weighing Systems, Rice Lake, WI, USA), and height will be measured using a portable stadiometer (213; SECA, CA, USA). Subjects will be then instructed to rinse their mouth with water and rest in a quiet room for 10 minutes. During this time, they will be equipped with a heart rate (HR) monitor (Polar verity sense; Polar Electro Ltd, Kempele, Finland). Immediately after the 10 minute rest period, an initial saliva sample, HR and SAI measures were collected (45 min prior to mental stress task). Five min after this (40 min pre mental stress task), subjects will consume their assigned treatment: either the placebo (crystal light + 8 oz of water) or caffeine supplement (200 mg caffeine + crystal light + 8 oz of water ). Throughout the experimental session, HR, SAI, and saliva samples will be collected a total of four times: 1) 45 minutes prior to the start of the mental stress task, 2) immediately before the mental stress task, 3) immediately after the mental stress task, and 4) 30 min after the mental stress task.
Mental Stress Task: Cognitive Challenge \& VR-ASD The stress protocol used for this experiment will utilize a cognitive challenge and a previously studied VR-ASD. The cognitive challenge will include a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). Immediately upon completion of the cognitive challenge, the subjects will complete the VR-ASD scenario (~2 min) followed by the same cognitive challenge with different questions (another 4 min). The total duration was ~10 min.
Stroop Challenge For the Stroop challenge, the subjects will be presented with a 0.5 second display of a word on the computer screen (i.e., yellow, green, red, or blue). However, the word is written in conflicting-color font presenting a mental conflict. Subjects are required to identify the text font color as quickly as possible using a color-coded keypad. Note, 0.5 seconds was allowed for the response. Feedback included total attempts, total correct and incorrect responses, missed responses, and response time.
Arithmetic Calculations The arithmetic calculations consisted of addition and subtraction with single, double-, and triple-digit numbers (e.g., 736 minus 58). The subject was given 10 seconds to respond to each mathematical question. Failure to respond within the allotted time resulted in an incorrect response. The subjects were presented with 2-min of the Stroop Challenge followed by 2-min of mental arithmetic. This will occur both before and after the VR-ASD.
Virtual Reality Active Shooter Drill The general procedures for the VR-ASD are previously described and based on a live -action ASD protocol (McAllister et. al., 2020). Briefly, the subject advanced down a ~3-meter-long hallway where two wounded victims were encountered. A white female victim with traumatic injuries was laying on the ground while an African American female victim "ran" out of a classroom with a gunshot wound to the left arm and leg. Upon arriving to the classroom, the subject observed a white female on the ground with a traumatic head injury as well as the shooter (white male) firing a handgun at an African American male. The subject was required to fire his/her weapon to prevent the shooter from turning toward the subject and eliciting a response. Once the shooter fell down after being shot by the subject, the VR-ASD scenario ended. The VR-ASD was presented using HTC VIVE Pro VR equipment (HTC Corp, New Taipei, Taiwan). The VR laboratory environment is larger than the virtual environment (~35 ft x 20 ft); therefore, subjects are able to physical maneuver throughout the ASD without disruption.
Supplement Ingestion Caffeine supplement capsules containing 200 mg caffeine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada)will be used for the present study. The capsules will be broken into halves and the caffeine powder inside was mixed with 8 oz of water and calorie free crystal light. For the placebo treatment, the same flavor of crystal light will be mixed with 8 oz of water.add that the treatments were flavor/sweetness matched.
For the theanine treatment, 200mg pure theanine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada) will be mixed with 8 oz water and crystal light
for the tyrosine treatment, 2000mg of tyrosine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada) will be mixed with 8oz of water and crystal light.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Subjects will be randomly assigned to one of four treatments: 1. placebo ingestion 2. caffeine ingestion 3. theanine ingestion 4. tyrosine ingestion nutrient ingestion takes place 40 min prior to being exposed to a mental stress task.
| Arm | Type | Receives |
|---|---|---|
| Caffeine group | Experimental | Other: mental stress taskSubjects will receive 200 mg of caffeine powder which was obtained from a 200 mg capsule (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada). Researchers will break open the capsule and mix with water and 5/8 tsp of crystal light immediately before subjects ingest the randomly assigned treatment. |
| Placebo | Placebo comparator | Other: mental stress taskflavored water (sweetened with crystal light powder, 0.5 tsp) will be provided to subjects without any caffeine powder added. |
| Theanine group | Experimental | Other: mental stress task200mg pure theanine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada) + 8 oz water+ 0.55 tsp crystal light will be ingested. |
| Tyrosine group | Experimental | Other: mental stress task2000 mg pure tyrosine powder (Hard Eight Nutrition, LLC, dba, Bulk Supplements, Henderson, Nevada) +8 oz water + 0.5 tsp crystal light will be ingested. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- apparently healthy, aged 18-40,
- free from any known cardiovascular or metabolic diseases,
- free from any major stressors within the last 30 days such as birth of a child, abortion, or divorce.
Key exclusion criteria (2 listed)
- subjects are required to not have a history of motion sickness or vertigo,
- not previously diagnosed with a brain injury or epilepsy.
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 |
|---|---|---|
| mental stress taskThe stress protocol used for this experiment utilized a cognitive challenge and a previously studied virtual reality active shooter drill (VR-ASD). The cognitive challenge included a modified version of the Stroop challenge (2 min) and mental arithmetic calculations (2 min) presented to the subject via e-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh, PA, USA). Immediately upon completion of the cognitive challenge, the subjects completed the VR-ASD scenario (~2 min) followed by the same cognitive challenge with different questions (another 4 min). The total duration was ~10 min. | Other | Caffeine group, Placebo, Theanine group, Tyrosine group |
Primary outcome
salivary secretory IgA
Time frame: Up to 10 months
SIgA is a marker of immune function and salivary SIgA concentrations tend to increase when exposed to stress
salivary alpha amylase
Time frame: Up to 10 months
salivary alpha amylase is an enzyme involved in digestive processes. amylase concentrations in saliva have been shown to reflect sympathetic stress. Thus, as sympathetic stress increases, salivary alpha amylase concentrations tend to increase
salivary cortisol
Time frame: Up to 10 months
salivary cortisol is a marker of stress which reflects activation of the hypothalamic pituitary adrenal axis.
heart rate
Time frame: Up to 10 months
heart rate reflects activity from the parasympathetic and sympathetic nervous system and increases when exposed to stress
State anxiety inventory
Time frame: Up to 10 months
state anxiety inventory is a subjective scale which includes six short statements such as "I feel calm" or " I feel tense" and composite scores of participant responses are used for analysis. Higher values reflect higher subjective anxiety.
6 secondary outcomes
mental arithmetic incorrect
Time frame: Up to 10 months
mental arithmetic missed responses
Time frame: Up to 10 months
mental arithmetic response time
Time frame: Up to 10 months
Stroop challenge number of incorrect
Time frame: Up to 10 months
Stroop challenge number of missed responses
Time frame: Up to 10 months
Stroop challenge response time
Time frame: Up to 10 months
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 12 Apr 2023.
- Derived from this study: PubMed 38975711McAllister MJ, Martaindale MH, Dillard CC, McCullough R. Impact of L-theanine and L-tyrosine on markers of stress and cognitive performance in response to a virtual reality based active shooter training drill. Stress. 2024 Jan;27(1):2375588. doi: 10.1080/10253890.2024.2375588. Epub 2024 Jul 8.
- Derived from this study: PubMed 38142605McAllister MJ, Martaindale MH, Dillard CC, Gonzalez DE. Stress response to virtual reality based active shooter training: Impact of caffeine consumption. Psychoneuroendocrinology. 2024 Mar;161:106923. doi: 10.1016/j.psyneuen.2023.106923. Epub 2023 Dec 7.
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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 mental stress task in people with Physiological Stress, run by Texas State University 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 3 inclusion and 2 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 12 Apr 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?
salivary secretory IgA (time frame: Up to 10 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592561, which also lists 2 linked publications.
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 12 Apr 2023.