<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/NCT02226250</url>
  </required_header>
  <id_info>
    <org_study_id>2014-031</org_study_id>
    <nct_id>NCT02226250</nct_id>
  </id_info>
  <brief_title>Absorption and Metabolic Profiles of a Sugar-based Beverage</brief_title>
  <acronym>SR</acronym>
  <official_title>Absorption Profile of a Sugar-based Beverage on Inflammatory Mechanism by Timing of Beverage Consumption Relative to Meal Intake.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Nutrition Research Center, Illinois Institute of Technology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Nutrition Research Center, Illinois Institute of Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary objective is to determine absorption profile of a sugar-based beverage on&#xD;
      inflammatory mechanism by timing of beverage consumption relative to meal intake.&#xD;
&#xD;
      Secondary objective is to determine absorption profile of a sugar-based beverage on oxidative&#xD;
      and metabolic mechanism by timing of beverage consumption relative to meal intake.&#xD;
&#xD;
      The results will be served as an internal reference or negative control group to compare with&#xD;
      polyphenol containing studies from other studies.&#xD;
&#xD;
      Each subject will receive 3 identical placebo drinks at each time points: fasting (0h), with&#xD;
      standardized breakfast meal (2h), and 2 hours after the breakfast meal (4h). A planned size&#xD;
      of 12 will be recruited into this part of the study.&#xD;
&#xD;
      This study is a single-arm design utilizing a multiple sampling, and repeated measures&#xD;
      paradigm to evaluate timing influence of consumption of sugar-based beverage associated acute&#xD;
      effect on inflammatory markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A planned sample size of 12 will be recruited into the study. This study will require one&#xD;
      initial screening visit, one pre-study visit, and 1 study visit. The study will take 1-2&#xD;
      weeks per subject to complete.&#xD;
&#xD;
      The initial screening visit will provide subject informed consent document and determine&#xD;
      subject eligibility through height and weight measurements, vital signs, blood glucose test&#xD;
      (finger prick), and completion of a survey related to general eating, health, and exercise&#xD;
      habits.&#xD;
&#xD;
      If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day)&#xD;
      will be instructed at initial screening visit and collected at a pre-study visit to assess&#xD;
      subjects' baseline dietary intake pattern. After reviewing baseline food records, subjects&#xD;
      will be instructed to avoid any berry products throughout the study and follow a strictly&#xD;
      limited polyphenolic diet for 3 days prior to the study visit, while maintaining their usual&#xD;
      diet pattern and physical activity. Prior to 10-hr study visit, a dinner meal will be&#xD;
      provided the day before the study visit to control the second meal effect from the food and&#xD;
      beverage intake of the night before the study visit.&#xD;
&#xD;
      Subject will arrive at the study visit fasted for at least 10 hours, well hydrated and&#xD;
      rested. Each study visit will require blood draws throughout the visit. After pre-study&#xD;
      procedures (height, weight, waist circumferences, vital sign, and blood glucose measurements)&#xD;
      , a registered nurse will place a catheter in subject's arm for the purpose of multiple blood&#xD;
      sample collections and take the initial blood draw at fasting. Thereafter, blood sample&#xD;
      collection will occur every 1 hour for the next 10 hours. During the 10-hr study visit,&#xD;
      subject will drink one of 3 identical placebo drinks at fasting (right after fasting blood&#xD;
      draw), 2nd placebo drink with the breakfast meal (2 hrs after fasting blood draw) and the 3rd&#xD;
      placebo drink at 2 hours after the breakfast meal (4 hrs after fasting blood draw).&#xD;
&#xD;
      Premenopausal female subjects will be studied during the follicular phase of their menstrual&#xD;
      cycle because food intake tends to be more stable during the follicular phase (days 1-13)&#xD;
      than during the luteal phase (days 14-28) when the rise in progesterone levels decrease&#xD;
      satiety often resulting in increased intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2014</start_date>
  <completion_date type="Actual">February 20, 2015</completion_date>
  <primary_completion_date type="Actual">January 13, 2015</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in inflammation markers over 10 hours after sugar beverage consumption at different time points.</measure>
    <time_frame>10 hr Postprandial paradigm</time_frame>
    <description>The timing influence of beverage consumption on inflammation markers in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in oxidative stress markers over 10 hours after sugar beverage consumption at different time points.</measure>
    <time_frame>10 hr</time_frame>
    <description>The timing influence of beverage consumption on oxidative stress (oxidized LDL) in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in metabolic markers over 10 hours after sugar beverage consumption at different time points.</measure>
    <time_frame>10 hr</time_frame>
    <description>The timing influence of sugar beverage consumption on metabolic markers (triglyceride, total cholesterol,ApoB, and insulin) in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Overweight</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>3 Placebo Beverages</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sugar beverage 2 hr before meal and with meal and 2 hr after meal</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>3 Placebo Beverages</intervention_name>
    <description>Sugar beverage 2 hr before meal, with meal and 2 hr after meal</description>
    <arm_group_label>3 Placebo Beverages</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and older&#xD;
&#xD;
          -  Body Mass Index (BMI) range from 25 to 29.9 kg/m2; exception BMI 23 to 27.4 kg/m2 for&#xD;
             Asian population&#xD;
&#xD;
          -  Nonsmoker&#xD;
&#xD;
          -  No clinical evidence of cardiovascular, metabolic, respiratory, renal,&#xD;
             gastrointestinal or hepatic disease&#xD;
&#xD;
          -  Not taking any medications that would interfere with outcomes of the study, i.e. lipid&#xD;
             lowering medications, anti-inflammatory drugs, or dietary supplements.&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Able to comply and perform the procedures requested by the protocol Weight stable: not&#xD;
             gained or lost weight +/- 5 kg in previous 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men and women who smoke&#xD;
&#xD;
          -  Past smokers: abstinence for minimum 2 years&#xD;
&#xD;
          -  Men and women with known or suspected food intolerance, allergies or hypersensitivity&#xD;
&#xD;
          -  Men and women known to have/diagnosed with diabetes mellitus&#xD;
&#xD;
          -  Men and women who have fasting blood glucose concentrations &gt; 125mg/dL&#xD;
&#xD;
          -  Men and women who have blood pressure &gt;140 mmHg/90 mmHg&#xD;
&#xD;
          -  Men and women with documented vascular disease, e.g., heart failure, myocardial&#xD;
             infarction, stroke, angina, related surgeries.&#xD;
&#xD;
          -  Men and women with cancer other than non-melanoma skin cancer in previous 5 years.&#xD;
&#xD;
          -  Women who are known to be pregnant or who are intending to become pregnant over the&#xD;
             course of the study&#xD;
&#xD;
          -  Women who are lactating&#xD;
&#xD;
          -  Taking medication or dietary supplements that may interfere with the outcomes of the&#xD;
             study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication.&#xD;
             Subjects may choose to go off dietary supplements (requires 30 days washout).&#xD;
&#xD;
          -  Men and women who have donated blood within 3 months of the screening visit and blood&#xD;
             donors/participants for whom participation in this study will result in having donated&#xD;
             more than 1500 milliliters of blood in the previous 12 months.&#xD;
&#xD;
          -  Men and women who are vegans&#xD;
&#xD;
          -  Substance (alcohol or drug) abuse within the last 2 years.&#xD;
&#xD;
          -  Excessive coffee and tea consumers (&gt; 4 cups/d)&#xD;
&#xD;
          -  Men and women who do excessive exercise regularly or athlete&#xD;
&#xD;
          -  Unstable weight: gained or lost weight +/- 5 kg in previous 3 months&#xD;
&#xD;
          -  Women who are taking hormonal contraceptive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Britt Burton-Freeman, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Illinois Institute of Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Nutrition Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sugar-based beverage</keyword>
  <keyword>Time Influence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT02226250
org study id: 2014-031
nct id: NCT02226250
lead sponsor: 
has dmc: Yes
Primary objective is to determine absorption profile of a sugar-based beverage on
      inflammatory mechanism by timing of beverage consumption relative to meal intake.

      Secondary objective is to determine absorption profile of a sugar-based beverage on oxidative
      and metabolic mechanism by timing of beverage consumption relative to meal intake.

      The results will be served as an internal reference or negative control group to compare with
      polyphenol containing studies from other studies.

      Each subject will receive 3 identical placebo drinks at each time points: fasting (0h), with
      standardized breakfast meal (2h), and 2 hours after the breakfast meal (4h). A planned size
      of 12 will be recruited into this part of the study.

      This study is a single-arm design utilizing a multiple sampling, and repeated measures
      paradigm to evaluate timing influence of consumption of sugar-based beverage associated acute
      effect on inflammatory markers.
A planned sample size of 12 will be recruited into the study. This study will require one
      initial screening visit, one pre-study visit, and 1 study visit. The study will take 1-2
      weeks per subject to complete.

      The initial screening visit will provide subject informed consent document and determine
      subject eligibility through height and weight measurements, vital signs, blood glucose test
      (finger prick), and completion of a survey related to general eating, health, and exercise
      habits.

      If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day)
      will be instructed at initial screening visit and collected at a pre-study visit to assess
      subjects' baseline dietary intake pattern. After reviewing baseline food records, subjects
      will be instructed to avoid any berry products throughout the study and follow a strictly
      limited polyphenolic diet for 3 days prior to the study visit, while maintaining their usual
      diet pattern and physical activity. Prior to 10-hr study visit, a dinner meal will be
      provided the day before the study visit to control the second meal effect from the food and
      beverage intake of the night before the study visit.

      Subject will arrive at the study visit fasted for at least 10 hours, well hydrated and
      rested. Each study visit will require blood draws throughout the visit. After pre-study
      procedures (height, weight, waist circumferences, vital sign, and blood glucose measurements)
      , a registered nurse will place a catheter in subject's arm for the purpose of multiple blood
      sample collections and take the initial blood draw at fasting. Thereafter, blood sample
      collection will occur every 1 hour for the next 10 hours. During the 10-hr study visit,
      subject will drink one of 3 identical placebo drinks at fasting (right after fasting blood
      draw), 2nd placebo drink with the breakfast meal (2 hrs after fasting blood draw) and the 3rd
      placebo drink at 2 hours after the breakfast meal (4 hrs after fasting blood draw).

      Premenopausal female subjects will be studied during the follicular phase of their menstrual
      cycle because food intake tends to be more stable during the follicular phase (days 1-13)
      than during the luteal phase (days 14-28) when the rise in progesterone levels decrease
      satiety often resulting in increased intake.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Changes in inflammation markers over 10 hours after sugar beverage consumption at different time points.
time frame: 10 hr Postprandial paradigm
description: The timing influence of beverage consumption on inflammation markers in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
measure: Changes in oxidative stress markers over 10 hours after sugar beverage consumption at different time points.
time frame: 10 hr
description: The timing influence of beverage consumption on oxidative stress (oxidized LDL) in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
measure: Changes in metabolic markers over 10 hours after sugar beverage consumption at different time points.
time frame: 10 hr
description: The timing influence of sugar beverage consumption on metabolic markers (triglyceride, total cholesterol,ApoB, and insulin) in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
arm group label: 3 Placebo Beverages
arm group type: Experimental
description: Sugar beverage 2 hr before meal and with meal and 2 hr after meal
intervention type: Dietary Supplement
intervention name: 3 Placebo Beverages
description: Sugar beverage 2 hr before meal, with meal and 2 hr after meal
arm group label: 3 Placebo Beverages
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Britt Burton-Freeman, Ph.D
role: Principal Investigator
affiliation: Illinois Institute of Technology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight