<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/NCT01683929</url>
  </required_header>
  <id_info>
    <org_study_id>MeirMc017112CTIL</org_study_id>
    <nct_id>NCT01683929</nct_id>
  </id_info>
  <brief_title>The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses</brief_title>
  <official_title>The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses and 24 Hour Macronutrient Consumption - A Double Blind, Cross-over Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to determine the hormonal/metabolic reponse to ingestion of sugar&#xD;
      compared to consuming artificial sweetened drink, and to evalute macronutrient consumption 24&#xD;
      hours post ingestion of the drinks.&#xD;
&#xD;
      We hypothesize that artificially sweetened (AS) consumption will lead to a relatively similar&#xD;
      hormonal/metabolic responses as glucose consumption and therefore to secondary rise of&#xD;
      caloric intake.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the last two decades, the prevalence of overweight and obesity doubled. at the same&#xD;
      time, individuals have increasingly turned to artificially sweetened (AS) foods and beverages&#xD;
      in an attempt to lose weight, or control it.&#xD;
&#xD;
      several studies have found that there may be a connection between artificially sweetened food&#xD;
      and beverages consumption and paradoxical weight gain and increased incidence of metabolic&#xD;
      syndrome. the causal relationship between AS use and weight gain haven't been proven yet.&#xD;
&#xD;
      The participants will be invited to 2 meetings in which they will consume, in a randomized&#xD;
      double blind way:&#xD;
&#xD;
        1. A beverage containing 75 gram glucose&#xD;
&#xD;
        2. A beverage containing 0.42 gram artificially sweetener (Aspartame, similar sweetness&#xD;
           level)&#xD;
&#xD;
      During each meeting, the participants will drink the sweetened drink followed by blood work,&#xD;
      as done in oral glucose challenge or tolerance test (OGTT / GTT).&#xD;
&#xD;
      Also, they will record their macronutrient\caloric consumption during the 24 hour following&#xD;
      the test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hormonal response</measure>
    <time_frame>3 hours</time_frame>
    <description>All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH- and other related hormones before consuming the drink (time 0), and 30, 60, 120, 180 minutes after.&#xD;
The participants will be under medical supervision throughout the examination, including HR &amp; BP montoring, and until 1 hour after</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>food questionnaire</measure>
    <time_frame>24 hours</time_frame>
    <description>The participants will be receiving a- &quot;24 hr food questionnaire&quot; which they will fill during the day after consuming the drink followed by an interview in order to get the maximal information.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Oral glucose tolerance test</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants will consume a beverage containing 75 gram glucose During the meeting, the participants will drink the sweetened drink followed by blood work, at 0, 30, 60, 120, 180 minutes. Also, they will record their macronutrient\caloric consumption during the 24 hour following the test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Artificial sweetner</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>participants will consume a beverage containing 0.42 gram artificial sweetener (Aspartame) During each meeting, the participants will drink the sweetened drink followed by blood work, at 0, 30, 60, 120, 180 minutes.&#xD;
Also, they will record their macronutrient\caloric consumption during the 24 hour following the test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>glucose</intervention_name>
    <description>The participants will report to the lab after an overnight fast. Their BMI, HR and BP will be measured. An IV catheter will be inserted into the brachial vein and the participants will rest for half an hour. Participants will drink A beverage containing 75 gram glucose (oral glucose tolerance test (OGTT / GTT) All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH and other related hormones- before consuming the drink (time 0), and at 30, 60, 120, 180 minutes after.&#xD;
The participants HR &amp; BP will be monitored throughout the examination + 1 hour after.&#xD;
In addition, the participants will be asked to complete a- &quot;24 hr food questionnaire&quot;.</description>
    <arm_group_label>Oral glucose tolerance test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sweetner</intervention_name>
    <description>The participants will report to the lab after an overnight fast. Their BMI, HR and BP will be measured. An IV catheter will be inserted into the brachial vein and the participants will rest for half an hour. Participants will drink A beverage containing artificial sweetened drink. All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH and other related hormones- before consuming the drink (time 0), and at 30, 60, 120, 180 minutes after.&#xD;
The participants HR &amp; BP will be monitored throughout the examination + 1 hour after.&#xD;
In addition, the participants will be asked to complete a- &quot;24 hr food questionnaire&quot;.</description>
    <arm_group_label>Artificial sweetner</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults, healthy, men and women, ages 25-35 years, without any chronic illnesses.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Family history of diabetes or overweight with BMI&gt; 27&#xD;
&#xD;
          -  Use of drugs who can influence the glucose metabolism (exp: glucocorticoids).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dan Nemet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center, Kfar-Saba, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar-Saba</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>April 13, 2015</last_update_submitted>
  <last_update_submitted_qc>April 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Overweight</keyword>
  <keyword>Sugar consumption</keyword>
  <keyword>Metabolic syndrome</keyword>
  <keyword>Artificially sweetened foods and beverages</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT01683929
org study id: MeirMc017112CTIL
nct id: NCT01683929
lead sponsor: 
has dmc: No
The goal of this study is to determine the hormonal/metabolic reponse to ingestion of sugar
      compared to consuming artificial sweetened drink, and to evalute macronutrient consumption 24
      hours post ingestion of the drinks.

      We hypothesize that artificially sweetened (AS) consumption will lead to a relatively similar
      hormonal/metabolic responses as glucose consumption and therefore to secondary rise of
      caloric intake.
During the last two decades, the prevalence of overweight and obesity doubled. at the same
      time, individuals have increasingly turned to artificially sweetened (AS) foods and beverages
      in an attempt to lose weight, or control it.

      several studies have found that there may be a connection between artificially sweetened food
      and beverages consumption and paradoxical weight gain and increased incidence of metabolic
      syndrome. the causal relationship between AS use and weight gain haven't been proven yet.

      The participants will be invited to 2 meetings in which they will consume, in a randomized
      double blind way:

        1. A beverage containing 75 gram glucose

        2. A beverage containing 0.42 gram artificially sweetener (Aspartame, similar sweetness
           level)

      During each meeting, the participants will drink the sweetened drink followed by blood work,
      as done in oral glucose challenge or tolerance test (OGTT / GTT).

      Also, they will record their macronutrient\caloric consumption during the 24 hour following
      the test.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Screening
masking: Single (Participant)
measure: Hormonal response
time frame: 3 hours
description: All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH- and other related hormones before consuming the drink (time 0), and 30, 60, 120, 180 minutes after.
The participants will be under medical supervision throughout the examination, including HR & BP montoring, and until 1 hour after
measure: food questionnaire
time frame: 24 hours
description: The participants will be receiving a- "24 hr food questionnaire" which they will fill during the day after consuming the drink followed by an interview in order to get the maximal information.
arm group label: Oral glucose tolerance test
arm group type: Active Comparator
description: The participants will consume a beverage containing 75 gram glucose During the meeting, the participants will drink the sweetened drink followed by blood work, at 0, 30, 60, 120, 180 minutes. Also, they will record their macronutrient\caloric consumption during the 24 hour following the test.
arm group label: Artificial sweetner
arm group type: Placebo Comparator
description: participants will consume a beverage containing 0.42 gram artificial sweetener (Aspartame) During each meeting, the participants will drink the sweetened drink followed by blood work, at 0, 30, 60, 120, 180 minutes.
Also, they will record their macronutrient\caloric consumption during the 24 hour following the test.
intervention type: Other
intervention name: glucose
description: The participants will report to the lab after an overnight fast. Their BMI, HR and BP will be measured. An IV catheter will be inserted into the brachial vein and the participants will rest for half an hour. Participants will drink A beverage containing 75 gram glucose (oral glucose tolerance test (OGTT / GTT) All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH and other related hormones- before consuming the drink (time 0), and at 30, 60, 120, 180 minutes after.
The participants HR & BP will be monitored throughout the examination + 1 hour after.
In addition, the participants will be asked to complete a- "24 hr food questionnaire".
arm group label: Oral glucose tolerance test
intervention type: Other
intervention name: sweetner
description: The participants will report to the lab after an overnight fast. Their BMI, HR and BP will be measured. An IV catheter will be inserted into the brachial vein and the participants will rest for half an hour. Participants will drink A beverage containing artificial sweetened drink. All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH and other related hormones- before consuming the drink (time 0), and at 30, 60, 120, 180 minutes after.
The participants HR & BP will be monitored throughout the examination + 1 hour after.
In addition, the participants will be asked to complete a- "24 hr food questionnaire".
arm group label: Artificial sweetner
criteria: 
gender: All
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dan Nemet, MD
role: Principal Investigator
affiliation: Meir Medical Center, Kfar-Saba, Israel
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Obesity