<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/NCT02255201</url>
  </required_header>
  <id_info>
    <org_study_id>GPN-2014</org_study_id>
    <nct_id>NCT02255201</nct_id>
  </id_info>
  <brief_title>Pre-Workout on Exercise Performance and Cognition</brief_title>
  <official_title>A Randomized, Double-Blind, Crossover Clinical Trial Comparing the Effects of Four Pre-Workout Beverages on Muscular Strength and Endurance and Cognitive Performance in Healthy Adult Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miami Research Associates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glanbia Performance Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Miami Research Associates</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effects of four different pre-workout beverages&#xD;
      as compared to placebo on muscular strength and endurance, perceived energy and cognitive&#xD;
      performance in healthy adult males.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Muscular Strength and Endurance compared to Placebo</measure>
    <time_frame>One day</time_frame>
    <description>Muscular Strength and Endurance will be measured by Bench Press and Leg Press 1-RM and repetitions to exhaustion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Cognitive Performance</measure>
    <time_frame>Baseline to one-hour post dose and immediately post exercise</time_frame>
    <description>Cognitive performance will be measured by the automated trail maker tests A and B.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from Baseline in Perceived Energy and Fatigue</measure>
    <time_frame>Baseline to one-hour post dose and immediately post exercise</time_frame>
    <description>Perceived Energy and Fatigue will be measured by the Profile of Mood States.</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Beverage A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose, Pre-Workout Master Performance Blend Dose 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Beverage B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose, Pre-Workout Master Performance Blend Dose 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Beverage C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose, Pre-Workout Performance Energy Blend</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Beverage D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose, Pre-Workout Energy Blend</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Beverage E</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose, Pre-Workout Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Master Performance Blend Dose 1</intervention_name>
    <description>Caffeine content: 200 mg</description>
    <arm_group_label>Beverage A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Master Performance Blend Dose 2</intervention_name>
    <description>Caffeine content: 400 mg</description>
    <arm_group_label>Beverage B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Performance Energy Blend</intervention_name>
    <description>Caffeine content: 175 mg</description>
    <arm_group_label>Beverage C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Energy Blend</intervention_name>
    <description>Caffeine content: 200 mg</description>
    <arm_group_label>Beverage D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Caffeine content: 0 mg</description>
    <arm_group_label>Beverage E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males, aged 18 to 40 years&#xD;
&#xD;
          2. Subject has a waist circumference ≤ 97 cm.&#xD;
&#xD;
          3. Subject is a non-smoker.&#xD;
&#xD;
          4. Subject is in good health and appropriate for exercise as determined by physical&#xD;
             examination, medical history and ECG.&#xD;
&#xD;
          5. Subject is weight training for the 6 months prior to starting the trial.&#xD;
&#xD;
          6. Subject agrees to not use any new vitamins and/or minerals until after study&#xD;
             completion and to not take any vitamins and/or minerals 24 hours prior to the test&#xD;
             visits.&#xD;
&#xD;
          7. Subject agrees to not use any dietary or herbal supplements until after study&#xD;
             completion. A 7-day washout is allowed for study inclusion.&#xD;
&#xD;
          8. Subject is willing and able to comply with the protocol including:&#xD;
&#xD;
               -  Attending 5 visits each of which is approximately 4 hours long;&#xD;
&#xD;
               -  Refraining from caffeine, over-the-counter medications and alcohol for the 24&#xD;
                  hours prior to the test visits;&#xD;
&#xD;
               -  Refraining from weight training for the 48 hours prior and refraining from any&#xD;
                  exercise other than weight training for 24 hours prior to the test visits;&#xD;
&#xD;
               -  Refraining from taking any dietary or herbal supplements throughout the study.&#xD;
&#xD;
          9. Subject is able to understand and sign the informed consent to participate in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has any of the following medical conditions:&#xD;
&#xD;
               -  active heart disease&#xD;
&#xD;
               -  uncontrolled high blood pressure (≥ 140/90 mmHg)&#xD;
&#xD;
               -  renal or hepatic impairment/disease&#xD;
&#xD;
               -  Type I or II diabetes&#xD;
&#xD;
               -  bipolar disorder&#xD;
&#xD;
               -  pulmonary disease (including current asthma)&#xD;
&#xD;
               -  Parkinson's disease&#xD;
&#xD;
               -  Seizure disorder&#xD;
&#xD;
               -  unstable thyroid disease&#xD;
&#xD;
               -  immune disorder (such as HIV/AIDS)&#xD;
&#xD;
               -  active psychiatric disorders (including anxiety disorders)&#xD;
&#xD;
               -  bleeding disorders&#xD;
&#xD;
               -  gastrointestinal ulcer disease&#xD;
&#xD;
               -  any medical condition deemed exclusionary by the Principal Investigator (PI)&#xD;
&#xD;
          2. Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which&#xD;
             make(s) resistance weight training contraindicated.&#xD;
&#xD;
          3. Subject has a history of cancer (except localized skin cancer without metastases)&#xD;
             within 5 years prior to screening.&#xD;
&#xD;
          4. No prescription or chronic medication use allowed without PI discretion.&#xD;
&#xD;
          5. Subject is currently taking and unwilling to refrain from taking any over-the-counter&#xD;
             stimulant medications/supplements (see section 2.6.2); seven-day washout required for&#xD;
             study inclusion.&#xD;
&#xD;
          6. Subject is currently taking and unwilling to refrain from taking any over-the-counter&#xD;
             allergy or asthma medication containing pseudoephedrine or ephedrine (see section&#xD;
             2.6.2); seven-day washout required for study inclusion.&#xD;
&#xD;
          7. Subject has an allergy to milk and phenylalanine, or any of the ingredients in the&#xD;
             test product (see section 3.2.1).&#xD;
&#xD;
          8. Subject reports sensitivity to caffeine and/or beta-alanine.&#xD;
&#xD;
          9. Subject reports being a regular caffeine consumer defined as consuming &gt; 600 mg of&#xD;
             caffeine per day.&#xD;
&#xD;
         10. Subject exhibits evidence of hepatic or renal dysfunction as evidenced by ALT, AST, AP&#xD;
             being ≥ two times the upper limit of normal or serum creatinine value ≥ 2.0 mg/dl or&#xD;
             other clinically significant abnormal clinical laboratory value per PI discretion.&#xD;
&#xD;
         11. Subject has a clinically relevant abnormality as defined by the PI or interpreting&#xD;
             physician with respect to the ECG.&#xD;
&#xD;
         12. Subject has a QTcB interval &gt; 450 msec.&#xD;
&#xD;
         13. Subject has a history of drug or alcohol abuse in the past 12 months.&#xD;
&#xD;
         14. Subject has any condition or abnormality that, in the opinion of the investigator,&#xD;
             would compromise the safety of the subject or the quality of the study data.&#xD;
&#xD;
         15. Subject has taken an investigational product within 30 days of the first exercise test&#xD;
             visit (visit 2).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Miami Research Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>April 6, 2015</last_update_submitted>
  <last_update_submitted_qc>April 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02255201
org study id: GPN-2014
nct id: NCT02255201
lead sponsor: 
collaborator: 
The purpose of this study is to determine the effects of four different pre-workout beverages
      as compared to placebo on muscular strength and endurance, perceived energy and cognitive
      performance in healthy adult males.
allocation: Randomized
intervention model: Crossover Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Muscular Strength and Endurance compared to Placebo
time frame: One day
description: Muscular Strength and Endurance will be measured by Bench Press and Leg Press 1-RM and repetitions to exhaustion.
measure: Change from Baseline in Cognitive Performance
time frame: Baseline to one-hour post dose and immediately post exercise
description: Cognitive performance will be measured by the automated trail maker tests A and B.
measure: Change from Baseline in Perceived Energy and Fatigue
time frame: Baseline to one-hour post dose and immediately post exercise
description: Perceived Energy and Fatigue will be measured by the Profile of Mood States.
arm group label: Beverage A
arm group type: Active Comparator
description: Single dose, Pre-Workout Master Performance Blend Dose 1
arm group label: Beverage B
arm group type: Active Comparator
description: Single dose, Pre-Workout Master Performance Blend Dose 2
arm group label: Beverage C
arm group type: Active Comparator
description: Single dose, Pre-Workout Performance Energy Blend
arm group label: Beverage D
arm group type: Active Comparator
description: Single dose, Pre-Workout Energy Blend
arm group label: Beverage E
arm group type: Placebo Comparator
description: Single dose, Pre-Workout Placebo
intervention type: Dietary Supplement
intervention name: Master Performance Blend Dose 1
description: Caffeine content: 200 mg
arm group label: Beverage A
intervention type: Dietary Supplement
intervention name: Master Performance Blend Dose 2
description: Caffeine content: 400 mg
arm group label: Beverage B
intervention type: Dietary Supplement
intervention name: Performance Energy Blend
description: Caffeine content: 175 mg
arm group label: Beverage C
intervention type: Dietary Supplement
intervention name: Energy Blend
description: Caffeine content: 200 mg
arm group label: Beverage D
intervention type: Dietary Supplement
intervention name: Placebo
description: Caffeine content: 0 mg
arm group label: Beverage E
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor