xml: <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/NCT05998096</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-23-95</org_study_id>
      <nct_id>NCT05998096</nct_id>
    </id_info>
    <brief_title>A Randomized Study to Examine the Ability of a Caffeine-Based Energy Drink to Impact Energy Expenditure, Fat Oxidation, Reaction Time, and Other Perceptual Indicators</brief_title>
    <acronym>ASH</acronym>
    <official_title>A Randomized Study to Examine the Ability of a Caffeine-Based Energy Drink to Impact Energy Expenditure, Fat Oxidation, Reaction Time, and Other Perceptual Indicators</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lindenwood University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lindenwood University</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 study is to evaluate the changes in energy expenditure, fat oxidation,&#xD;
        reaction time, and perceptual indicators of energy and focus after acute ingestion of a&#xD;
        caffeine-based energy drink. Approximately 60 healthy adults aged 18-50 will be recruited for&#xD;
        a randomized, double-blind, placebo-controlled study. They will undergo baseline measurements&#xD;
        for energy expenditure, fat and carbohydrate oxidation, reaction time, cognition, and&#xD;
        perceptual indicators of energy, focus, and concentration. After 28 days, these measurements&#xD;
        will be taken again, comparing the effects of a caffeine-based energy drink versus a placebo.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be conducted using a randomized, double-blind, placebo-controlled, parallel&#xD;
        study design. Approximately 60 healthy men and women between the ages of 18 - 55 years of age&#xD;
        will be recruited to participate in this study. Prior to beginning the study, all&#xD;
        participants will sign an IRB-approved informed consent document and complete a health&#xD;
        history questionnaire to determine study eligibility. All participants will report to the&#xD;
        laboratory for all study visits between 0600 - 1000 hours. Prior to each study visit,&#xD;
        participants will be asked to abstain from exercise, tobacco, nicotine, and alcohol for 12&#xD;
        hours and observe an overnight (8 - 10 hours) fast including caffeine. Study visit 1 will be&#xD;
        a screening visit where participants will first sign an IRB-approved informed consent&#xD;
        document. To determine eligibility, participants will then complete a health and medical&#xD;
        history form and have their height and weight assessed along with their resting heart rate&#xD;
        and blood pressure. If determined eligible, study participants will then have their body&#xD;
        composition assessed and then be asked to record their past 24-hour intake of food and fluid.&#xD;
        This form will be copied and all participants will be instructed to replicate this diet prior&#xD;
        to each visit.&#xD;
  &#xD;
        Study visits 2 and 3 will be identical and separated by approximately 28 days whereby each&#xD;
        study participant will have ingested a single dose of their assigned beverage each day&#xD;
        between visits 2 and 3. Prior to these visits, participants will not be allowed to exercise&#xD;
        within 24 hours of each subsequent study visit and may only partake in a light workout two&#xD;
        days prior to their study visit. Participants will be instructed to follow an overnight fast&#xD;
        whereby no food or fluid with calories will be consumed for the 8 to 10-hour period prior to&#xD;
        each study visit. Water intake will be encouraged during this time for appropriate hydration&#xD;
        status. Upon arrival for study visits 2 and 3, body mass will be assessed before having their&#xD;
        body temperature, resting heart rate, and blood pressure assessed. From there, participants&#xD;
        will be instructed to complete simple and choice reaction time and cognition assessments&#xD;
        using a DynaVision board. After cognition assessments are completed, visual analog scales&#xD;
        will be completed to assess perceived levels of energy, focus, and concentration. Finally,&#xD;
        participants will then complete a resting metabolic assessment to evaluate rates of calorie&#xD;
        burning (energy expenditure), rate of fat oxidation, and amount of fat oxidized. After&#xD;
        completion of all assessments, participants will ingest their assigned dose of beverage. Each&#xD;
        participant will be given 15 minutes to ingest their assigned beverage. As soon as the entire&#xD;
        beverage is consumed, the study protocol timer will be activated and all subsequent&#xD;
        assessments will occur as outlined. During visit 2 (dose 1) and visit 3 (dose 28),&#xD;
        participants will have energy expenditure and fat oxidation assessments completed 0, 30, 60,&#xD;
        90, and 120 minutes after ingestion while cognition, hemodynamics, and VAS will be evaluated&#xD;
        0, 60, and 120 minutes.&#xD;
  &#xD;
        Participants will be assigned to each group in a randomized, double-blind, placebo-controlled&#xD;
        fashion with parallel groups that are matched according to BMI and gender. This will ensure&#xD;
        each study condition has similar numbers of males and females that are of similar body mass&#xD;
        index levels. After completion of study visit 2, participants will be provided with a 14-day&#xD;
        supply of their assigned beverage. After 14 days, participants must return to the laboratory&#xD;
        to pick up their remaining assigned beverage and communicate with research staff about&#xD;
        compliance, adverse events, etc. After 28 days of supplementation, participants will return&#xD;
        to the laboratory for study visit 3, which will complete their participation in the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</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>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized, double-blind, placebo-controlled, parallel study design</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Conditions will be packaged into non-descript, identical cans with identical flavoring.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Energy expenditure (kcals/min)</measure>
      <time_frame>28 days</time_frame>
      <description>Impact of a caffeine-based energy drink ingestion on energy expenditure (calorie burning)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rates of fat oxidation</measure>
      <time_frame>28 days</time_frame>
      <description>Impact of a caffeine-based energy drink ingestion on fat oxidation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Energy Visual Analog Scale</measure>
      <time_frame>28 days</time_frame>
      <description>Impact of a caffeine-based energy drink ingestion on perceptual indicators of affect through visual analog scales (VAS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Focus Visual Analog Scale</measure>
      <time_frame>28 days</time_frame>
      <description>Impact of a caffeine-based energy drink ingestion on perceptual indicators of affect through visual analog scales (VAS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration Visual Analog Scale</measure>
      <time_frame>28 days</time_frame>
      <description>Impact of a caffeine-based energy drink ingestion on perceptual indicators of affect through visual analog scales (VAS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Simple reaction time</measure>
      <time_frame>28 days</time_frame>
      <description>Impact of a caffeine-based energy drink ingestion on reaction time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Choice reaction time</measure>
      <time_frame>28 days</time_frame>
      <description>Impact of a caffeine-based energy drink ingestion on reaction time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trail Making Test</measure>
      <time_frame>28 days</time_frame>
      <description>Impact of a caffeine-based energy drink ingestion on cognition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serial Sevens</measure>
      <time_frame>28 days</time_frame>
      <description>Impact of a caffeine-based energy drink ingestion on cognition</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Self-reported adverse events</measure>
      <time_frame>28 days</time_frame>
      <description>Self-reported adverse events</description>
    </other_outcome>
    <other_outcome>
      <measure>Heart Rate</measure>
      <time_frame>28 days</time_frame>
      <description>Resting heart rate</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood Pressure</measure>
      <time_frame>28 days</time_frame>
      <description>Resting Blood Pressure</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Energy Expenditure</condition>
    <condition>Cognition</condition>
    <condition>Reaction Time</condition>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo (void of all actives)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Caffeine-Based Energy Drink</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Caffeine-based energy drink containing 200 mg caffeine</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Caffeine-Based Energy Drink</intervention_name>
      <description>Caffeine-based energy drink containing 200 mg caffeine</description>
      <arm_group_label>Caffeine-Based Energy Drink</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo void of all active ingredients</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
            1. Male or female participants between 18 - 50 years of age&#xD;
  &#xD;
            2. Signed informed consent&#xD;
  &#xD;
            3. Healthy, is defined as currently not being treated for an active cardiac, pulmonary,&#xD;
               metabolic, immunological, neurological, respiratory, orthopedic, musculoskeletal,&#xD;
               psychiatric, or reproductive disease or disorder. With the research team and principal&#xD;
               investigator's discretion, some ongoing treatments will be permitted if a&#xD;
               determination is made that the treatment will not increase the risk of study&#xD;
               participation and the treatment will not confound with desired study outcomes&#xD;
  &#xD;
            4. Physically active is defined as performing aerobic or resistance-based physical&#xD;
               exercise between 2 and 5 times per week&#xD;
  &#xD;
            5. Moderate caffeine users (~300 mg/day)&#xD;
  &#xD;
            6. Body mass index values will range from &gt;24.0 to &lt; 31.9 kg/m2. The average body mass&#xD;
               index for the entire study cohort will be less than 31.99 kg/m2. As such an ongoing&#xD;
               calculation of the recruited cohort's mean body mass index will be maintained and&#xD;
               people will only be randomized into the study if the average cohort body mass index&#xD;
               value does not exceed 31.99 kg/m2&#xD;
  &#xD;
            7. Willing and able to agree to the requirements and restrictions of this study, be&#xD;
               willing to give voluntary consent, and carry out all study-related procedures&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            1. Body mass index &gt; 31.9 kg/m2&#xD;
  &#xD;
            2. Positive medical history and/or is currently being treated for some form of heart or&#xD;
               cardiovascular, neurological impairment, disease or condition, immune disorder or&#xD;
               disease, thyroid disease, kidney disease, renal failure, regular dialysis, liver&#xD;
               disease, or other diagnosed hepatic impairment&#xD;
  &#xD;
            3. Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose&#xD;
               &gt; 126 mg/dL)&#xD;
  &#xD;
            4. Diagnosed with a major affective disorder or other psychiatric disorder that required&#xD;
               hospitalization in the prior year&#xD;
  &#xD;
            5. History of cancer (except localized skin cancer without metastases or in situ 6.&#xD;
               cervical cancer within 5 years prior to screening visit).&#xD;
  &#xD;
          7. Participant has an abnormality or obstruction of the gastrointestinal tract precluding&#xD;
          swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac&#xD;
          disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea) 7. Currently&#xD;
          prescribed statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension&#xD;
          medications (i.e., Beta-blockers, ACE Inhibitors, Alpha-blockers, 8. Vasodilators, etc.) or&#xD;
          any other medication at the discretion of the principal investigator 9. Current smoker (&gt;10&#xD;
          cigarettes per day) 10. Participants who are lactating, pregnant, or planning to become&#xD;
          pregnant History of alcohol or substance abuse in the 6 months prior to screening 11.&#xD;
          Receipt or use of an investigational product in another research study within 60 days of&#xD;
          beginning the study protocol 12. Any condition or abnormality that, in the opinion of the&#xD;
          investigator, would compromise the safety of the participant or the quality of the study&#xD;
          data 13. Extensive travel (&gt;1 month) that will disrupt the original outline of the study&#xD;
          protocol&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Exercise and Performance Nutrition Laboratory</name>
        <address>
          <city>Saint Charles</city>
          <state>Missouri</state>
          <zip>63301</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>energy expenditure</keyword>
    <keyword>cognition</keyword>
    <keyword>reaction time</keyword>
    <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>
  
  
text: 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/NCT05998096
  org study id: IRB-23-95
  nct id: NCT05998096
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the changes in energy expenditure, fat oxidation,
        reaction time, and perceptual indicators of energy and focus after acute ingestion of a
        caffeine-based energy drink. Approximately 60 healthy adults aged 18-50 will be recruited for
        a randomized, double-blind, placebo-controlled study. They will undergo baseline measurements
        for energy expenditure, fat and carbohydrate oxidation, reaction time, cognition, and
        perceptual indicators of energy, focus, and concentration. After 28 days, these measurements
        will be taken again, comparing the effects of a caffeine-based energy drink versus a placebo.
  The study will be conducted using a randomized, double-blind, placebo-controlled, parallel
        study design. Approximately 60 healthy men and women between the ages of 18 - 55 years of age
        will be recruited to participate in this study. Prior to beginning the study, all
        participants will sign an IRB-approved informed consent document and complete a health
        history questionnaire to determine study eligibility. All participants will report to the
        laboratory for all study visits between 0600 - 1000 hours. Prior to each study visit,
        participants will be asked to abstain from exercise, tobacco, nicotine, and alcohol for 12
        hours and observe an overnight (8 - 10 hours) fast including caffeine. Study visit 1 will be
        a screening visit where participants will first sign an IRB-approved informed consent
        document. To determine eligibility, participants will then complete a health and medical
        history form and have their height and weight assessed along with their resting heart rate
        and blood pressure. If determined eligible, study participants will then have their body
        composition assessed and then be asked to record their past 24-hour intake of food and fluid.
        This form will be copied and all participants will be instructed to replicate this diet prior
        to each visit.
  
        Study visits 2 and 3 will be identical and separated by approximately 28 days whereby each
        study participant will have ingested a single dose of their assigned beverage each day
        between visits 2 and 3. Prior to these visits, participants will not be allowed to exercise
        within 24 hours of each subsequent study visit and may only partake in a light workout two
        days prior to their study visit. Participants will be instructed to follow an overnight fast
        whereby no food or fluid with calories will be consumed for the 8 to 10-hour period prior to
        each study visit. Water intake will be encouraged during this time for appropriate hydration
        status. Upon arrival for study visits 2 and 3, body mass will be assessed before having their
        body temperature, resting heart rate, and blood pressure assessed. From there, participants
        will be instructed to complete simple and choice reaction time and cognition assessments
        using a DynaVision board. After cognition assessments are completed, visual analog scales
        will be completed to assess perceived levels of energy, focus, and concentration. Finally,
        participants will then complete a resting metabolic assessment to evaluate rates of calorie
        burning (energy expenditure), rate of fat oxidation, and amount of fat oxidized. After
        completion of all assessments, participants will ingest their assigned dose of beverage. Each
        participant will be given 15 minutes to ingest their assigned beverage. As soon as the entire
        beverage is consumed, the study protocol timer will be activated and all subsequent
        assessments will occur as outlined. During visit 2 (dose 1) and visit 3 (dose 28),
        participants will have energy expenditure and fat oxidation assessments completed 0, 30, 60,
        90, and 120 minutes after ingestion while cognition, hemodynamics, and VAS will be evaluated
        0, 60, and 120 minutes.
  
        Participants will be assigned to each group in a randomized, double-blind, placebo-controlled
        fashion with parallel groups that are matched according to BMI and gender. This will ensure
        each study condition has similar numbers of males and females that are of similar body mass
        index levels. After completion of study visit 2, participants will be provided with a 14-day
        supply of their assigned beverage. After 14 days, participants must return to the laboratory
        to pick up their remaining assigned beverage and communicate with research staff about
        compliance, adverse events, etc. After 28 days of supplementation, participants will return
        to the laboratory for study visit 3, which will complete their participation in the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized, double-blind, placebo-controlled, parallel study design
  primary purpose: Other
  masking: Double (Participant, Investigator)
  masking description: Conditions will be packaged into non-descript, identical cans with identical flavoring.
  measure: Energy expenditure (kcals/min)
  time frame: 28 days
  description: Impact of a caffeine-based energy drink ingestion on energy expenditure (calorie burning)
  measure: Rates of fat oxidation
  time frame: 28 days
  description: Impact of a caffeine-based energy drink ingestion on fat oxidation
  measure: Energy Visual Analog Scale
  time frame: 28 days
  description: Impact of a caffeine-based energy drink ingestion on perceptual indicators of affect through visual analog scales (VAS)
  measure: Focus Visual Analog Scale
  time frame: 28 days
  description: Impact of a caffeine-based energy drink ingestion on perceptual indicators of affect through visual analog scales (VAS)
  measure: Concentration Visual Analog Scale
  time frame: 28 days
  description: Impact of a caffeine-based energy drink ingestion on perceptual indicators of affect through visual analog scales (VAS)
  measure: Simple reaction time
  time frame: 28 days
  description: Impact of a caffeine-based energy drink ingestion on reaction time
  measure: Choice reaction time
  time frame: 28 days
  description: Impact of a caffeine-based energy drink ingestion on reaction time
  measure: Trail Making Test
  time frame: 28 days
  description: Impact of a caffeine-based energy drink ingestion on cognition
  measure: Serial Sevens
  time frame: 28 days
  description: Impact of a caffeine-based energy drink ingestion on cognition
  measure: Self-reported adverse events
  time frame: 28 days
  description: Self-reported adverse events
  measure: Heart Rate
  time frame: 28 days
  description: Resting heart rate
  measure: Blood Pressure
  time frame: 28 days
  description: Resting Blood Pressure
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo (void of all actives)
  arm group label: Caffeine-Based Energy Drink
  arm group type: Active Comparator
  description: Caffeine-based energy drink containing 200 mg caffeine
  intervention type: Dietary Supplement
  intervention name: Caffeine-Based Energy Drink
  description: Caffeine-based energy drink containing 200 mg caffeine
  arm group label: Caffeine-Based Energy Drink
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: Placebo void of all active ingredients
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Caffeine
  sharing ipd: No