<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/NCT03840863</url>
  </required_header>
  <id_info>
    <org_study_id>19-02</org_study_id>
    <nct_id>NCT03840863</nct_id>
  </id_info>
  <brief_title>Effects of Chronic Energy Drink Consumption on Cardiometabolic Endpoints</brief_title>
  <official_title>Effects of Chronic Energy Drink Consumption on Cardiometabolic Endpoints</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Pacific</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the Pacific</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>
      Many people use energy drinks (EDs) regularly, but the overall health concerns are still&#xD;
      unknown. There are many energy drink products that contain a mixture of caffeine and other&#xD;
      energy-boosting ingredients and supplements which can affect parameters related to the heart,&#xD;
      blood pressure and blood glucose. Several previous studies have shown that energy drinks may&#xD;
      affect heart rhythm and blood pressure significantly. As energy drinks are sugar-sweetened&#xD;
      beverages, long-term use may also affect the body's metabolism, including cholesterol, blood&#xD;
      sugars, and weight.&#xD;
&#xD;
      The purpose of this study is to learn if drinking energy drinks everyday may affect a&#xD;
      person's cardiometabolic health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The popularity of energy drinks (EDs) have increased over the last few decades due to their&#xD;
      purported benefits as mental and physical performance enhancements. While caffeine is a major&#xD;
      ingredient in most EDs (ranging from 80 mg to 500 mg per drink), they may also contain&#xD;
      various supplements, such as guarana, taurine, ginseng, B vitamins, gluconolactone, yohimbe,&#xD;
      carnitine, and bitter orange, as well as high amount of sugar (ranging from 25-50 grams). The&#xD;
      United States Food and Drug Administration (FDA) has cited that a daily intake of 400 mg&#xD;
      caffeine (approximately 4-5 cups of coffee) in adults is generally safe and not associated&#xD;
      with dangerous, negative effects. The Substance Abuse and Mental Health Services&#xD;
      Administration reported a doubling of emergency department visits involving EDs from 10,068&#xD;
      visits in 2007 to 20,783 visits in 2011. Commonly reported adverse reactions include&#xD;
      insomnia, nervousness, headache, tachycardia, and seizures. Currently, the health effects of&#xD;
      long-term ED use remain unknown.&#xD;
&#xD;
      This study is a proof-of-concept, prospective trial that aims to evaluate the effects of&#xD;
      chronic ED consumption on cardiometabolic parameters in a healthy population. Subjects will&#xD;
      consume two cans (16 oz.) of an energy drink daily for 4 weeks. The study will assess any&#xD;
      changes in blood pressure (BP), electrocardiographic (ECG) parameters, blood glucose,&#xD;
      cholesterol, weight, body mass index (BMI), and body fat composition before and after&#xD;
      consuming EDs for 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2019</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood pressure before and 1 hour after energy drink consumption</measure>
    <time_frame>1 hour</time_frame>
    <description>Measuring acute changes in peripheral systolic blood pressure before and 1 hour after energy drink consumption</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in blood pressure before and after 4 weeks of energy drink consumption</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measuring chronic changes in peripheral systolic blood pressure before and 4 weeks after energy drink consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in QTc Interval before and after 1 hour of energy drink consumption</measure>
    <time_frame>1 hour</time_frame>
    <description>Measuring change in QTc interval via electrocardiogram before and after 1 hour of energy drink consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QTc Interval before and after 4 weeks of energy drink consumption</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measuring change in QTc interval via electrocardiogram before and after 4 weeks of energy drink consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting blood glucose before and after 4 weeks of energy drink consumption</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measuring the change in fasting blood glucose before and after 4 weeks of energy drink consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting lipid panel parameters before and after 4 weeks of energy drink consumption</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measuring the changes in total cholesterol (TC), high-density lipoprotein (HDL), triglyceride (TG), and calculated low-density lipoprotein (LDL-C) levels before and after 4 weeks of energy drink consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index before and after 4 weeks of energy drink consumption</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measuring the change in Body Mass Index (BMI) before and after 4 weeks of energy drink consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Fat Analysis before and after 4 weeks of energy drink consumption</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measuring the changes in Body Fat Analysis before and after 4 weeks of energy drink consumption, including percentage of body fat, fat mass, muscle mass, and fat in trunk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Serum Creatinine before and after 4 weeks of energy drink consumption</measure>
    <time_frame>4 weeks</time_frame>
    <description>Measuring the change in Serum Creatinine before and after 4 weeks of energy drink consumption</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Commercially-Available Energy drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers willing to consume two cans of energy drinks (16 oz./can) daily for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Commercially-Available Energy Drink</intervention_name>
    <description>Participant will consume 2 cans of an energy drink (16 oz./can) per day. One in the morning and one in the afternoon.</description>
    <arm_group_label>Commercially-Available Energy drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults aged 18 - 40 years&#xD;
&#xD;
          -  Participants willing to adhere to study drink schedule (28 days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Naïve caffeine consumers (&lt; 2 cups of coffee [or equivalent caffeine intake] per week)&#xD;
&#xD;
          -  Chronic medical conditions including cardiovascular disease (known history of cardiac&#xD;
             arrhythmias, family history of premature sudden cardiac death before age 60,&#xD;
             cardiomyopathy, atherosclerosis), smoking, renal or hepatic dysfunction&#xD;
&#xD;
          -  Prolonged corrected QT (QTc) interval&#xD;
&#xD;
          -  History of substance abuse, including alcohol&#xD;
&#xD;
          -  Concurrent use of prescription drugs or over-the-counter products that may interact&#xD;
             with study drinks (with the exception of oral contraceptives that have been used for&#xD;
             over 1 month)&#xD;
&#xD;
          -  Baseline Blood Pressure greater than 140/90 mmHg&#xD;
&#xD;
          -  Baseline fasting blood glucose greater than 126 mg/dL or random blood glucose greater&#xD;
             than 200 mg/dL&#xD;
&#xD;
          -  Females only: pregnancy or lactation, or planning to get pregnant within next 28 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>May Chen, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the Pacific</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of the Pacific</name>
      <address>
        <city>Stockton</city>
        <state>California</state>
        <zip>95211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>November 5, 2020</last_update_submitted>
  <last_update_submitted_qc>November 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Energy Drink</keyword>
  <keyword>Blood Pressure</keyword>
  <keyword>Arrhythmia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT03840863
org study id: 19-02
nct id: NCT03840863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many people use energy drinks (EDs) regularly, but the overall health concerns are still
      unknown. There are many energy drink products that contain a mixture of caffeine and other
      energy-boosting ingredients and supplements which can affect parameters related to the heart,
      blood pressure and blood glucose. Several previous studies have shown that energy drinks may
      affect heart rhythm and blood pressure significantly. As energy drinks are sugar-sweetened
      beverages, long-term use may also affect the body's metabolism, including cholesterol, blood
      sugars, and weight.

      The purpose of this study is to learn if drinking energy drinks everyday may affect a
      person's cardiometabolic health.
The popularity of energy drinks (EDs) have increased over the last few decades due to their
      purported benefits as mental and physical performance enhancements. While caffeine is a major
      ingredient in most EDs (ranging from 80 mg to 500 mg per drink), they may also contain
      various supplements, such as guarana, taurine, ginseng, B vitamins, gluconolactone, yohimbe,
      carnitine, and bitter orange, as well as high amount of sugar (ranging from 25-50 grams). The
      United States Food and Drug Administration (FDA) has cited that a daily intake of 400 mg
      caffeine (approximately 4-5 cups of coffee) in adults is generally safe and not associated
      with dangerous, negative effects. The Substance Abuse and Mental Health Services
      Administration reported a doubling of emergency department visits involving EDs from 10,068
      visits in 2007 to 20,783 visits in 2011. Commonly reported adverse reactions include
      insomnia, nervousness, headache, tachycardia, and seizures. Currently, the health effects of
      long-term ED use remain unknown.

      This study is a proof-of-concept, prospective trial that aims to evaluate the effects of
      chronic ED consumption on cardiometabolic parameters in a healthy population. Subjects will
      consume two cans (16 oz.) of an energy drink daily for 4 weeks. The study will assess any
      changes in blood pressure (BP), electrocardiographic (ECG) parameters, blood glucose,
      cholesterol, weight, body mass index (BMI), and body fat composition before and after
      consuming EDs for 4 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in blood pressure before and 1 hour after energy drink consumption
time frame: 1 hour
description: Measuring acute changes in peripheral systolic blood pressure before and 1 hour after energy drink consumption
measure: Change in blood pressure before and after 4 weeks of energy drink consumption
time frame: 4 weeks
description: Measuring chronic changes in peripheral systolic blood pressure before and 4 weeks after energy drink consumption
measure: Change in QTc Interval before and after 1 hour of energy drink consumption
time frame: 1 hour
description: Measuring change in QTc interval via electrocardiogram before and after 1 hour of energy drink consumption
measure: Change in QTc Interval before and after 4 weeks of energy drink consumption
time frame: 4 weeks
description: Measuring change in QTc interval via electrocardiogram before and after 4 weeks of energy drink consumption
measure: Change in fasting blood glucose before and after 4 weeks of energy drink consumption
time frame: 4 weeks
description: Measuring the change in fasting blood glucose before and after 4 weeks of energy drink consumption
measure: Change in fasting lipid panel parameters before and after 4 weeks of energy drink consumption
time frame: 4 weeks
description: Measuring the changes in total cholesterol (TC), high-density lipoprotein (HDL), triglyceride (TG), and calculated low-density lipoprotein (LDL-C) levels before and after 4 weeks of energy drink consumption
measure: Change in Body Mass Index before and after 4 weeks of energy drink consumption
time frame: 4 weeks
description: Measuring the change in Body Mass Index (BMI) before and after 4 weeks of energy drink consumption
measure: Change in Body Fat Analysis before and after 4 weeks of energy drink consumption
time frame: 4 weeks
description: Measuring the changes in Body Fat Analysis before and after 4 weeks of energy drink consumption, including percentage of body fat, fat mass, muscle mass, and fat in trunk
measure: Change in Serum Creatinine before and after 4 weeks of energy drink consumption
time frame: 4 weeks
description: Measuring the change in Serum Creatinine before and after 4 weeks of energy drink consumption
arm group label: Commercially-Available Energy drink
arm group type: Experimental
description: Healthy volunteers willing to consume two cans of energy drinks (16 oz./can) daily for 4 weeks
intervention type: Dietary Supplement
intervention name: Commercially-Available Energy Drink
description: Participant will consume 2 cans of an energy drink (16 oz./can) per day. One in the morning and one in the afternoon.
arm group label: Commercially-Available Energy drink
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: May Chen, PharmD
role: Principal Investigator
affiliation: University of the Pacific
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No