Mental FatigueNCT03019523
The Effect of a Caffeine Blend on Reaction Time, Mental Performance and Focus in Athletic Males
A study testing Caffeine Blend and Sugar Pill in people with Mental Fatigue, run by University of Mary Hardin-Baylor at 1 site in United States.
Trial summary
This is a cross-over design study in which subjects arrived to the lab and were assigned a supplement to ingest. Prior to ingestion subjects completed baseline reaction time testing along with a questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue
- What is being tested?
- Caffeine Blend and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2016
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be males between the ages of 18-25 years
- Subjects will be team sport athletes or highly trained
- Subjects will not be able to smoke or use tobacco
- Subjects has provided written and dated informed consent to participate in the study
- Subjects is willing and able to comply with the protocol
- Subjects is apparently healthy and free from disease, as determined by a health history questionnaire
Show all 15Show fewer
- Subjects is a regular caffeine consumer (up to 2 cups of coffee a day)
- Subjects agrees to abstain from caffeine the day of each testing session
- Subjects agrees to abstain from exercise 24 hours prior to each testing visit. 48 hours prior to the testing session, the subject should not do anything new or unaccustomed in the form of exercise and should not increase the intensity of their workouts.
- Subject Exclusion Criteria
- Subject has not been participating in regular physical activity and exercise trained for at least 12 months prior to enrollment
- Subject is diagnosed with any metabolic or chronic disease, or is on prescription medication for the diagnosed metabolic or chronic disease
- Subject is using, or has used a dietary supplement (other than a multi-vitamin/-mineral, protein powder, or meal replacements) within 6 weeks prior to enrollment. Protein/Meal Replacement Products (MRPs) must not contain any supplements such as creatine, beta-alanine, hydroxyl methlybutyrate (HMB), etc.
- Subject is in, or has participated in another clinical trial within 8 weeks prior to enrollment
- Subject has a known allergy or sensitivity to caffeine or other stimulants (determined from health history questionnaire.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of A Proprietary Supplement On The Acute Responses In Reaction Time, Mental Performance, And Indicators Of Focus In Athletic Populations
This is a cross-over design study in which subjects arrived to the lab and were assigned a supplement to ingest. Prior to ingestion subjects completed baseline reaction time testing along with a questionnaire. Thirty minutes after ingestion subjects filled out the same questionnaire, completed a reaction time test, followed by a series of dynamic exercises. After the last exercise was finished subjects filled out the questionnaire, completed another reaction time test and repeated the series of dynamic exercises. Following the exercises, subjects filled out the questionnaire and completed a fourth round of reaction time testing. In total subjects would complete 2 rounds of dynamic exercises and 4 rounds of reaction time testing with heart rate being recorded before and after the dynamic exercise rounds. Subjects were told to wash-out for 7 days and return to the lab to complete the same testing but on the alternative supplement.
Read the detailed description
Subjects expressing interest in doing the study, were interviewed in the Human Performance Lab (HPL) to determine whether they appear to qualify to participate in the study. Qualifying subjects, were then invited back to the HPL for an entry/familiarization session and be verbally told all of the requirements of the study. During this session, subjects signed Informed Consent Statements and completed personal and medical history questionnaires. Subject were familiarized to the study protocol via a verbal and written explanation outlining the study design. This included describing the testing sessions to the subjects about the tests to be performed including the Makoto testing system (reaction time testing). Subjects practiced several times during this session to eliminate the learning curve of using new equipment. Subjects were also taken through 1 round of the dynamic exercises to ensure ability to complete each exercise as needed. Subjects were then given an appointment time to perform qualifying Makoto testing to achieve greater than or equal to 70% accuracy on 3 towers at a level 7 for three consecutive trails.
Following the practice session, subjects recorded all food intake via MyFitnessPal for three days (3-d) prior to baseline testing. Subjects were instructed to refrain from exercise, caffeine, and alcohol the day prior to baseline testing and to consume their normal breakfast the morning of testing. Subjects were given a meal replacement bar in place of lunch, to consume ~2 hours before their testing session. During this time, subjects had body composition and hemodynamic assessments recorded. Two hours after ingestion of meal bar subjects reported back to the HPL and completed a Visual Analog Scale (VAS) questionnaire, a baseline Makoto prior to ingesting their assigned supplement. Thirty minutes after ingestion, Makoto and dynamic exercisers were completed. This involved subjects doing a standardized full body workout in 2 different rounds of exercise. After each round of exercise subjects filled out the VAS and performed Makoto testing. Subject then were instructed to wash-out and were scheduled for their 2nd testing session ~7 days later.
- Conditions
- Mental Fatigue
- Being tested
- Caffeine Blend, Sugar Pill
- Keywords
- caffeine, mental performance, reaction time, focus
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine BlendDietary supplement
Taken orally in capsule form
Sugar PillOther
Taken orally in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Maltodextrin (~2 grams to match weight of active treatment) placebo pre-testing (1 dose w/3 oz of water) 30 minutes following ingestion exercise and Makoto testing were completed. Receives: Other: Sugar Pill |
| Caffeine Blend | Active comparator | 75 mg caffeine, 75 mg theanine, and 2g tyrosine pre-testing (1 dose w/3 oz of water) 30 minutes following ingestion exercise and Makoto testing were completed. Receives: Dietary Supplement: Caffeine Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Caffeine on Measures of Reaction Time by Makoto
The primary purpose of this investigation is to determine if acute ingestion of a proprietary supplement containing caffeine, theanine, and tyrosine has any positive effects on markers of reaction time in athletic populations.
Measured: up to 4 hours
Response to Caffeine on Measures of Mental Performance by Survey in Athletic Populatons
The primary purpose of this investigation is to determine if acute ingestion of a proprietary supplement containing caffeine, theanine, and tyrosine has any positive effects on markers of mental performance in athletic populations.
Measured: up to 4 hours
Response to Caffeine on Measures of Cognitive Fatigue by Survey in Athletic Populatons
The primary purpose of this investigation is to determine if acute ingestion of a proprietary supplement containing caffeine, theanine, and tyrosine has any positive effects on markers of cognitive fatigue in athletic populations.
Measured: up to 4 hours
Secondary outcomes (1)
Response to Caffeine on Measures of Physical Performance by Comparing the Total Amount of Work Completed
The secondary purpose of this investigation is to determine if acute ingestion of a proprietary supplement containing caffeine, theanine, and tyrosine has any positive effects on markers of physical performance in athletic populations.
Measured: up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental FatigueStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mary Hardin-Baylor
- Sponsor type
- University, hospital or other
- Collaborators
- NBTY, Inc.
- Responsible party
- Principal investigator, Lemuel W. Taylor IV, University of Mary Hardin-Baylor
- Investigators
- Lemuel W Taylor, PhD, Principal investigator, UMHB Human Performance Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019523
- Sponsor's protocol ID
- NBTY-1
- Status last verified
- Jan 2017
- First submitted
- 15 Dec 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zaragoza J, Tinsley G, Urbina S, Villa K, Santos E, Juaneza A, Tinnin M, Davidson C, Mitmesser S, Zhang Z, Taylor L. Effects of acute caffeine, theanine and tyrosine supplementation on mental and physical performance in athletes. J Int Soc Sports Nutr. 2019 Nov 26;16(1):56. doi: 10.1186/s12970-019-0326-3.
PubMed 31771598
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of A Proprietary Supplement On The Acute Responses In Reaction Time, Mental Performance, And Indicators Of Focus In Athletic Populations
- ClinicalTrials.gov ID
- NCT03019523
- Acronym / sponsor ID
- NBTY-1
- Conditions
- Mental Fatigue
- Keywords
- caffeine, mental performance, reaction time, focus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Mary Hardin-BaylorUniversity, hospital or other
- Collaborators
- NBTY, Inc.
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Jan 2017 (estimated)
- 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.
This is a cross-over design study in which subjects arrived to the lab and were assigned a supplement to ingest. Prior to ingestion subjects completed baseline reaction time testing along with a questionnaire. Thirty minutes after ingestion subjects filled out the same questionnaire, completed a reaction time test, followed by a series of dynamic exercises. After the last exercise was finished subjects filled out the questionnaire, completed another reaction time test and repeated the series of dynamic exercises. Following the exercises, subjects filled out the questionnaire and completed a fourth round of reaction time testing. In total subjects would complete 2 rounds of dynamic exercises and 4 rounds of reaction time testing with heart rate being recorded before and after the dynamic exercise rounds. Subjects were told to wash-out for 7 days and return to the lab to complete the same testing but on the alternative supplement.
Detailed description
Subjects expressing interest in doing the study, were interviewed in the Human Performance Lab (HPL) to determine whether they appear to qualify to participate in the study. Qualifying subjects, were then invited back to the HPL for an entry/familiarization session and be verbally told all of the requirements of the study. During this session, subjects signed Informed Consent Statements and completed personal and medical history questionnaires. Subject were familiarized to the study protocol via a verbal and written explanation outlining the study design. This included describing the testing sessions to the subjects about the tests to be performed including the Makoto testing system (reaction time testing). Subjects practiced several times during this session to eliminate the learning curve of using new equipment. Subjects were also taken through 1 round of the dynamic exercises to ensure ability to complete each exercise as needed. Subjects were then given an appointment time to perform qualifying Makoto testing to achieve greater than or equal to 70% accuracy on 3 towers at a level 7 for three consecutive trails.
Following the practice session, subjects recorded all food intake via MyFitnessPal for three days (3-d) prior to baseline testing. Subjects were instructed to refrain from exercise, caffeine, and alcohol the day prior to baseline testing and to consume their normal breakfast the morning of testing. Subjects were given a meal replacement bar in place of lunch, to consume ~2 hours before their testing session. During this time, subjects had body composition and hemodynamic assessments recorded. Two hours after ingestion of meal bar subjects reported back to the HPL and completed a Visual Analog Scale (VAS) questionnaire, a baseline Makoto prior to ingesting their assigned supplement. Thirty minutes after ingestion, Makoto and dynamic exercisers were completed. This involved subjects doing a standardized full body workout in 2 different rounds of exercise. After each round of exercise subjects filled out the VAS and performed Makoto testing. Subject then were instructed to wash-out and were scheduled for their 2nd testing session ~7 days later.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Other: Sugar PillMaltodextrin (~2 grams to match weight of active treatment) placebo pre-testing (1 dose w/3 oz of water) 30 minutes following ingestion exercise and Makoto testing were completed. |
| Caffeine Blend | Active comparator | Dietary Supplement: Caffeine Blend75 mg caffeine, 75 mg theanine, and 2g tyrosine pre-testing (1 dose w/3 oz of water) 30 minutes following ingestion exercise and Makoto testing were completed. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Subjects will be males between the ages of 18-25 years
- Subjects will be team sport athletes or highly trained
- Subjects will not be able to smoke or use tobacco
- Subjects has provided written and dated informed consent to participate in the study
- Subjects is willing and able to comply with the protocol
Key exclusion criteria (0 listed)
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 BlendTaken orally in capsule form | Dietary supplement | Caffeine Blend |
| Sugar PillTaken orally in capsule form | Other | Sugar Pill |
Primary outcome
Response to Caffeine on Measures of Reaction Time by Makoto
Time frame: up to 4 hours
The primary purpose of this investigation is to determine if acute ingestion of a proprietary supplement containing caffeine, theanine, and tyrosine has any positive effects on markers of reaction time in athletic populations.
Response to Caffeine on Measures of Mental Performance by Survey in Athletic Populatons
Time frame: up to 4 hours
The primary purpose of this investigation is to determine if acute ingestion of a proprietary supplement containing caffeine, theanine, and tyrosine has any positive effects on markers of mental performance in athletic populations.
Response to Caffeine on Measures of Cognitive Fatigue by Survey in Athletic Populatons
Time frame: up to 4 hours
The primary purpose of this investigation is to determine if acute ingestion of a proprietary supplement containing caffeine, theanine, and tyrosine has any positive effects on markers of cognitive fatigue in athletic populations.
1 secondary outcome
Response to Caffeine on Measures of Physical Performance by Comparing the Total Amount of Work Completed
Time frame: up to 4 hours
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 25 Jan 2017.
- Derived from this study: PubMed 31771598Zaragoza J, Tinsley G, Urbina S, Villa K, Santos E, Juaneza A, Tinnin M, Davidson C, Mitmesser S, Zhang Z, Taylor L. Effects of acute caffeine, theanine and tyrosine supplementation on mental and physical performance in athletes. J Int Soc Sports Nutr. 2019 Nov 26;16(1):56. doi: 10.1186/s12970-019-0326-3.
- 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.
Lemuel W Taylor, PhD principal investigator
UMHB Human Performance Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine Blend and Sugar Pill in people with Mental Fatigue, run by University of Mary Hardin-Baylor 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 15 inclusion and 0 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 25 Jan 2017. 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?
Response to Caffeine on Measures of Reaction Time by Makoto (time frame: up to 4 hours). The study lists 3 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 NCT03019523, which also lists 1 linked publication.
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 25 Jan 2017.