<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/NCT04455009</url>
  </required_header>
  <id_info>
    <org_study_id>BIO-17-13679</org_study_id>
    <nct_id>NCT04455009</nct_id>
  </id_info>
  <brief_title>Acute Effects of Fitness Drink Formulas on Energy Expenditure and Fat Metabolism</brief_title>
  <official_title>The Acute Effects of Fitness Drink Formulas Containing 100 mg and 140 mg of Caffeine on Energy Expenditure and Fat Metabolism in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Central Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celsius Holdings, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Central Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this investigation was to examine the acute effects of consuming two different&#xD;
      fitness drink formulas on the physiological response at rest and to exercise in healthy men&#xD;
      and women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thermogenic fitness drinks containing ~200mg of caffeine have been reported to accelerate the&#xD;
      metabolism, increase energy, and consequently promote increased fat oxidation. However,&#xD;
      determination of the efficacy of lower caffeine concentrations may provide additional options&#xD;
      for individuals with preferences for reduced caffeine intake. Therefore, the aim of this&#xD;
      study was to evaluate different fitness drink formulas containing a total of 100mg and 140mg&#xD;
      of caffeine on the physiological response at rest and to exercise.&#xD;
&#xD;
      This study utilized a randomized, double-blind, placebo-controlled design. All participants&#xD;
      completed three testing visits during which they consumed the placebo, the 100mg caffeine&#xD;
      formula, and the 140mg caffeine formula. Blood samples, blood pressure, heart rate, resting&#xD;
      energy expenditure, substrate oxidation, and neurocognitive assessments were collected at&#xD;
      baseline and repeated 30, 60, and 90 minutes post-ingestion. Immediately following the last&#xD;
      cognitive assessment, a maximal graded exercise test with gas analysis was conducted on a&#xD;
      cycle ergometer to evaluate physical performance and maximal fat oxidation during exercise as&#xD;
      well as the physiological response prior to and following exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2018</start_date>
  <completion_date type="Actual">November 28, 2018</completion_date>
  <primary_completion_date type="Actual">November 28, 2018</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>Change in resting energy expenditure/substrate oxidation</measure>
    <time_frame>Baseline, 30, 60, and 90 min post-ingestion</time_frame>
    <description>Estimates from gas exchange analysis via indirect calorimetry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in energy expenditure/substrate oxidation in response to exercise</measure>
    <time_frame>&gt;90 min post-ingestion (pre/peri/post maximal graded exercise test)</time_frame>
    <description>Estimates from gas exchange analysis via indirect calorimetry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in resting serum glycerol</measure>
    <time_frame>Baseline, 30, 60, and 90 min post-ingestion</time_frame>
    <description>Obtained from blood draw of the superficial forearm vein</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in oxygen consumption/carbon dioxide production in response to exercise</measure>
    <time_frame>&gt;90 min post-ingestion (pre/peri/post maximal graded exercise test)</time_frame>
    <description>Estimates from gas exchange analysis via indirect calorimetry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in resting minute ventilation</measure>
    <time_frame>Baseline, 30, 60, and 90 min post-ingestion</time_frame>
    <description>Estimates from gas exchange analysis via indirect calorimetry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in minute ventilation in response to exercise</measure>
    <time_frame>&gt;90 min post-ingestion (pre/peri/post maximal graded exercise test)</time_frame>
    <description>Estimates from gas exchange analysis via indirect calorimetry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Automated Neuropsychological Assessment Metrics (ANAM) screening</measure>
    <time_frame>Baseline, 30, 60, and 90 min post-ingestion</time_frame>
    <description>Measures from mood scale, go/no go test, Stroop test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting blood pressure response</measure>
    <time_frame>Baseline, 30, 60, and 90 min post-ingestion</time_frame>
    <description>Measured via automated blood pressure monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting heart rate/heart rate variability</measure>
    <time_frame>Baseline, 30, 60, and 90 min post-ingestion</time_frame>
    <description>Measured via chest-based heart rate monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate/heart rate variability in response to exercise</measure>
    <time_frame>&gt;90 min post-ingestion (pre/peri/post maximal graded exercise test)</time_frame>
    <description>Measured via chest-based heart rate monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in power output</measure>
    <time_frame>&gt;90 min post-ingestion</time_frame>
    <description>Obtained via cycle ergometer during the maximal graded exercise test</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Caffeine</condition>
  <condition>Diet, Healthy</condition>
  <condition>Fat Burn</condition>
  <condition>Cognitive Change</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>100mg Caffeine Formula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10kcal drink containing a total of 100 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>140mg Caffeine Formula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10kcal drink containing a total of 140 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Formula</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>non-caloric/non-caffeinated drink</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fitness Drink Formula</intervention_name>
    <description>Single drink provided following baseline assessments</description>
    <arm_group_label>100mg Caffeine Formula</arm_group_label>
    <arm_group_label>140mg Caffeine Formula</arm_group_label>
    <arm_group_label>Placebo Formula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Young adult men and women between the ages of 18 and 35 years old.&#xD;
&#xD;
          -  Participant is deemed by the investigator to be healthy and free of any physical&#xD;
             limitations determined by physical activity readiness questionnaire (PAR-Q+) and&#xD;
             medical and activity history questionnaire (MHQ).&#xD;
&#xD;
          -  Participants will be required to be recreationally-active (defined according to&#xD;
             American College of Sports Medicine standards of at least 150 minutes exercise per&#xD;
             week and verified by information provided in the MHQ).&#xD;
&#xD;
          -  Participant is willing to abstain from dietary supplementation throughout the duration&#xD;
             of the study as indicated in the Informed Consent.&#xD;
&#xD;
          -  Participant understands the study procedures and signs forms providing informed&#xD;
             consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to perform physical exercise, as determined by the PAR-Q+.&#xD;
&#xD;
          -  Any &quot;Yes&quot; response in the PAR-Q+.&#xD;
&#xD;
          -  History of hypertension, metabolic, hepatorenal, musculoskeletal, autoimmune or&#xD;
             neurological disease, as determined by the MHQ.&#xD;
&#xD;
          -  Regular consumption of greater than 250 mg per day of caffeine&#xD;
&#xD;
          -  Currently taking thyroid, antihyperlipidemic, hypoglycemic, anti-hypertensive or&#xD;
             androgenic medications.&#xD;
&#xD;
          -  Taking any other nutritional supplement or performance-enhancing drug (determined from&#xD;
             MHQ) that may interfere with the outcome variables of the study.&#xD;
&#xD;
          -  Pregnancy (determined from MHQ).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Fukuda, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Central Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kinesiology Laboratories</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_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/NCT04455009
org study id: BIO-17-13679
nct id: NCT04455009
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this investigation was to examine the acute effects of consuming two different
      fitness drink formulas on the physiological response at rest and to exercise in healthy men
      and women.
Thermogenic fitness drinks containing ~200mg of caffeine have been reported to accelerate the
      metabolism, increase energy, and consequently promote increased fat oxidation. However,
      determination of the efficacy of lower caffeine concentrations may provide additional options
      for individuals with preferences for reduced caffeine intake. Therefore, the aim of this
      study was to evaluate different fitness drink formulas containing a total of 100mg and 140mg
      of caffeine on the physiological response at rest and to exercise.

      This study utilized a randomized, double-blind, placebo-controlled design. All participants
      completed three testing visits during which they consumed the placebo, the 100mg caffeine
      formula, and the 140mg caffeine formula. Blood samples, blood pressure, heart rate, resting
      energy expenditure, substrate oxidation, and neurocognitive assessments were collected at
      baseline and repeated 30, 60, and 90 minutes post-ingestion. Immediately following the last
      cognitive assessment, a maximal graded exercise test with gas analysis was conducted on a
      cycle ergometer to evaluate physical performance and maximal fat oxidation during exercise as
      well as the physiological response prior to and following exercise.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Change in resting energy expenditure/substrate oxidation
time frame: Baseline, 30, 60, and 90 min post-ingestion
description: Estimates from gas exchange analysis via indirect calorimetry
measure: Change in energy expenditure/substrate oxidation in response to exercise
time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
description: Estimates from gas exchange analysis via indirect calorimetry
measure: Change in resting serum glycerol
time frame: Baseline, 30, 60, and 90 min post-ingestion
description: Obtained from blood draw of the superficial forearm vein
measure: Change in oxygen consumption/carbon dioxide production in response to exercise
time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
description: Estimates from gas exchange analysis via indirect calorimetry
measure: Change in resting minute ventilation
time frame: Baseline, 30, 60, and 90 min post-ingestion
description: Estimates from gas exchange analysis via indirect calorimetry
measure: Change in minute ventilation in response to exercise
time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
description: Estimates from gas exchange analysis via indirect calorimetry
measure: Change in Automated Neuropsychological Assessment Metrics (ANAM) screening
time frame: Baseline, 30, 60, and 90 min post-ingestion
description: Measures from mood scale, go/no go test, Stroop test
measure: Change in resting blood pressure response
time frame: Baseline, 30, 60, and 90 min post-ingestion
description: Measured via automated blood pressure monitor
measure: Change in resting heart rate/heart rate variability
time frame: Baseline, 30, 60, and 90 min post-ingestion
description: Measured via chest-based heart rate monitor
measure: Change in heart rate/heart rate variability in response to exercise
time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
description: Measured via chest-based heart rate monitor
measure: Change in power output
time frame: >90 min post-ingestion
description: Obtained via cycle ergometer during the maximal graded exercise test
arm group label: 100mg Caffeine Formula
arm group type: Experimental
description: 10kcal drink containing a total of 100 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate
arm group label: 140mg Caffeine Formula
arm group type: Experimental
description: 10kcal drink containing a total of 140 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate
arm group label: Placebo Formula
arm group type: Placebo Comparator
description: non-caloric/non-caffeinated drink
intervention type: Dietary Supplement
intervention name: Fitness Drink Formula
description: Single drink provided following baseline assessments
arm group label: 100mg Caffeine Formula
arm group label: 140mg Caffeine Formula
arm group label: Placebo Formula
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Fukuda, PhD
role: Principal Investigator
affiliation: University of Central Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fatigue
sharing ipd: No