<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03019523</url>
  </required_header>
  <id_info>
    <org_study_id>NBTY-1</org_study_id>
    <nct_id>NCT03019523</nct_id>
  </id_info>
  <brief_title>The Effect of a Caffeine Blend on Reaction Time, Mental Performance and Focus in Athletic Males</brief_title>
  <official_title>Effects Of A Proprietary Supplement On The Acute Responses In Reaction Time, Mental Performance, And Indicators Of Focus In Athletic Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mary Hardin-Baylor</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NBTY, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Mary Hardin-Baylor</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a cross-over design study in which subjects arrived to the lab and were assigned a&#xD;
      supplement to ingest. Prior to ingestion subjects completed baseline reaction time testing&#xD;
      along with a questionnaire. Thirty minutes after ingestion subjects filled out the same&#xD;
      questionnaire, completed a reaction time test, followed by a series of dynamic exercises.&#xD;
      After the last exercise was finished subjects filled out the questionnaire, completed another&#xD;
      reaction time test and repeated the series of dynamic exercises. Following the exercises,&#xD;
      subjects filled out the questionnaire and completed a fourth round of reaction time testing.&#xD;
      In total subjects would complete 2 rounds of dynamic exercises and 4 rounds of reaction time&#xD;
      testing with heart rate being recorded before and after the dynamic exercise rounds. Subjects&#xD;
      were told to wash-out for 7 days and return to the lab to complete the same testing but on&#xD;
      the alternative supplement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects expressing interest in doing the study, were interviewed in the Human Performance&#xD;
      Lab (HPL) to determine whether they appear to qualify to participate in the study. Qualifying&#xD;
      subjects, were then invited back to the HPL for an entry/familiarization session and be&#xD;
      verbally told all of the requirements of the study. During this session, subjects signed&#xD;
      Informed Consent Statements and completed personal and medical history questionnaires.&#xD;
      Subject were familiarized to the study protocol via a verbal and written explanation&#xD;
      outlining the study design. This included describing the testing sessions to the subjects&#xD;
      about the tests to be performed including the Makoto testing system (reaction time testing).&#xD;
      Subjects practiced several times during this session to eliminate the learning curve of using&#xD;
      new equipment. Subjects were also taken through 1 round of the dynamic exercises to ensure&#xD;
      ability to complete each exercise as needed. Subjects were then given an appointment time to&#xD;
      perform qualifying Makoto testing to achieve greater than or equal to 70% accuracy on 3&#xD;
      towers at a level 7 for three consecutive trails.&#xD;
&#xD;
      Following the practice session, subjects recorded all food intake via MyFitnessPal for three&#xD;
      days (3-d) prior to baseline testing. Subjects were instructed to refrain from exercise,&#xD;
      caffeine, and alcohol the day prior to baseline testing and to consume their normal breakfast&#xD;
      the morning of testing. Subjects were given a meal replacement bar in place of lunch, to&#xD;
      consume ~2 hours before their testing session. During this time, subjects had body&#xD;
      composition and hemodynamic assessments recorded. Two hours after ingestion of meal bar&#xD;
      subjects reported back to the HPL and completed a Visual Analog Scale (VAS) questionnaire, a&#xD;
      baseline Makoto prior to ingesting their assigned supplement. Thirty minutes after ingestion,&#xD;
      Makoto and dynamic exercisers were completed. This involved subjects doing a standardized&#xD;
      full body workout in 2 different rounds of exercise. After each round of exercise subjects&#xD;
      filled out the VAS and performed Makoto testing. Subject then were instructed to wash-out and&#xD;
      were scheduled for their 2nd testing session ~7 days later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response to Caffeine on Measures of Reaction Time by Makoto</measure>
    <time_frame>up to 4 hours</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response to Caffeine on Measures of Mental Performance by Survey in Athletic Populatons</measure>
    <time_frame>up to 4 hours</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response to Caffeine on Measures of Cognitive Fatigue by Survey in Athletic Populatons</measure>
    <time_frame>up to 4 hours</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response to Caffeine on Measures of Physical Performance by Comparing the Total Amount of Work Completed</measure>
    <time_frame>up to 4 hours</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Mental Fatigue</condition>
  <arm_group>
    <arm_group_label>Sugar Pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caffeine Blend</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Caffeine Blend</intervention_name>
    <description>Taken orally in capsule form</description>
    <arm_group_label>Caffeine Blend</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sugar Pill</intervention_name>
    <description>Taken orally in capsule form</description>
    <arm_group_label>Sugar Pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Subjects will be males between the ages of 18-25 years&#xD;
&#xD;
          -  Subjects will be team sport athletes or highly trained&#xD;
&#xD;
          -  Subjects will not be able to smoke or use tobacco&#xD;
&#xD;
          -  Subjects has provided written and dated informed consent to participate in the study&#xD;
&#xD;
          -  Subjects is willing and able to comply with the protocol&#xD;
&#xD;
          -  Subjects is apparently healthy and free from disease, as determined by a health&#xD;
             history questionnaire&#xD;
&#xD;
          -  Subjects is a regular caffeine consumer (up to 2 cups of coffee a day)&#xD;
&#xD;
          -  Subjects agrees to abstain from caffeine the day of each testing session&#xD;
&#xD;
          -  Subjects agrees to abstain from exercise 24 hours prior to each testing visit. 48&#xD;
             hours prior to the testing session, the subject should not do anything new or&#xD;
             unaccustomed in the form of exercise and should not increase the intensity of their&#xD;
             workouts.&#xD;
&#xD;
        Subject Exclusion Criteria&#xD;
&#xD;
          -  Subject has not been participating in regular physical activity and exercise trained&#xD;
             for at least 12 months prior to enrollment&#xD;
&#xD;
          -  Subject is diagnosed with any metabolic or chronic disease, or is on prescription&#xD;
             medication for the diagnosed metabolic or chronic disease&#xD;
&#xD;
          -  Subject is using, or has used a dietary supplement (other than a&#xD;
             multi-vitamin/-mineral, protein powder, or meal replacements) within 6 weeks prior to&#xD;
             enrollment. Protein/Meal Replacement Products (MRPs) must not contain any supplements&#xD;
             such as creatine, beta-alanine, hydroxyl methlybutyrate (HMB), etc.&#xD;
&#xD;
          -  Subject is in, or has participated in another clinical trial within 8 weeks prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Subject has a known allergy or sensitivity to caffeine or other stimulants (determined&#xD;
             from health history questionnaire.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lemuel W Taylor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMHB Human Performance Lab</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UMHB Human Performance Lab</name>
      <address>
        <city>Belton</city>
        <state>Texas</state>
        <zip>76513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Mary Hardin-Baylor</investigator_affiliation>
    <investigator_full_name>Lemuel W. Taylor IV</investigator_full_name>
    <investigator_title>Director, Exercise Biochemistry Laboratory</investigator_title>
  </responsible_party>
  <keyword>caffeine</keyword>
  <keyword>mental performance</keyword>
  <keyword>reaction time</keyword>
  <keyword>focus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Fatigue</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03019523
org study id: NBTY-1
nct id: NCT03019523
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Response to Caffeine on Measures of Reaction Time by Makoto
time frame: up to 4 hours
description: 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.
measure: Response to Caffeine on Measures of Mental Performance by Survey in Athletic Populatons
time frame: up to 4 hours
description: 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.
measure: Response to Caffeine on Measures of Cognitive Fatigue by Survey in Athletic Populatons
time frame: up to 4 hours
description: 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.
measure: Response to Caffeine on Measures of Physical Performance by Comparing the Total Amount of Work Completed
time frame: up to 4 hours
description: 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.
arm group label: Sugar Pill
arm group type: Placebo Comparator
description: 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.
arm group label: Caffeine Blend
arm group type: Active Comparator
description: 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.
intervention type: Dietary Supplement
intervention name: Caffeine Blend
description: Taken orally in capsule form
arm group label: Caffeine Blend
intervention type: Other
intervention name: Sugar Pill
description: Taken orally in capsule form
arm group label: Sugar Pill
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lemuel W Taylor, PhD
role: Principal Investigator
affiliation: UMHB Human Performance Lab
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Mary Hardin-Baylor
investigator full name: Lemuel W. Taylor IV
investigator title: Director, Exercise Biochemistry Laboratory
mesh term: Mental Fatigue
mesh term: Caffeine
sharing ipd: No