<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/NCT02974478</url>
  </required_header>
  <id_info>
    <org_study_id>OrangeJuice</org_study_id>
    <nct_id>NCT02974478</nct_id>
  </id_info>
  <brief_title>Orange Juice Consumption and Glucose Metabolism and Antioxidative Status</brief_title>
  <official_title>Impact of Orange Juice Consumption on Glucose Homeostasis and Antioxidative Status in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hohenheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Hohenheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study is to investigate the impact of orange juice consumption (with meals or&#xD;
      between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on&#xD;
      glucose homeostasis and antioxidative status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Duration of the study is 3x three weeks including one wash-out week each followed by two&#xD;
      weeks of juice/SSB consumption under free living conditions.&#xD;
&#xD;
      During wash-out weeks consumption of orange juice or citrus fruits is restricted.&#xD;
&#xD;
      During intervention weeks, participants are asked to eat three regular meals per day without&#xD;
      snacking. Intervention weeks are (i) orange juice consumption with meals (ii) orange juice&#xD;
      consumption between meals and (iii) SSB consumption between meals. Daily energy intake with&#xD;
      orange juice/SSB is 20% of individual energy requirement. Additional caloric beverages (SSB,&#xD;
      juice, coffee with sugar/milk, alcohol) are not allowed. At the beginning and the end of each&#xD;
      intervention phase insulin sensitivity and antioxidative status are assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in daylong glycaemia between pre and post intervention periods</measure>
    <time_frame>two weeks</time_frame>
    <description>measured via continuous glucose monitoring [mg/dL]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in uric acid between pre and post intervention periods</measure>
    <time_frame>two weeks</time_frame>
    <description>measured via uric acid serum levels [mg/dL]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in insulin sensitivity between pre and post intervention periods</measure>
    <time_frame>two weeks</time_frame>
    <description>measured via &quot;Matsuda-Index&quot; from oral glucose tolerance test data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in antioxidative status between pre and post intervention periods</measure>
    <time_frame>two weeks</time_frame>
    <description>measured via vitamin c blood levels [mg/L]</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Orange juice with meals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Effect of orange juice consumption with three meals per day (without snacking) on glucose metabolism and antioxidative status</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orange juice between meals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Effect of orange juice consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar sweetened beverage between meals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Effect of sugar sweetened beverage consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Orange juice with meals</intervention_name>
    <description>orange juice (20% of energy requirement/day)</description>
    <arm_group_label>Orange juice with meals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Orange juice between meals</intervention_name>
    <description>orange juice (20% of energy requirement/day)</description>
    <arm_group_label>Orange juice between meals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sugar sweetened beverage between meals</intervention_name>
    <description>Sugar sweetened beverage (20% of energy requirement/day)</description>
    <arm_group_label>Sugar sweetened beverage between meals</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  regular use of medication,&#xD;
&#xD;
          -  smoking,&#xD;
&#xD;
          -  chronic disease,&#xD;
&#xD;
          -  vegan/vegetarian diet,&#xD;
&#xD;
          -  fructose intolerance,&#xD;
&#xD;
          -  irregular eating behaviour (less then 3 meals/day)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anja Bosy-Westphal, Prof PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Hohenheim, Stuttgart, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Nutritional Medicine, University of Hohenheim</name>
      <address>
        <city>Stuttgart</city>
        <zip>70599</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>April 22, 2017</last_update_submitted>
  <last_update_submitted_qc>April 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>orange juice consumption</keyword>
  <keyword>glucose homeostasis</keyword>
  <keyword>antioxidative status</keyword>
  <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/NCT02974478
org study id: OrangeJuice
nct id: NCT02974478
lead sponsor: 
has dmc: No
Aim of the study is to investigate the impact of orange juice consumption (with meals or
      between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on
      glucose homeostasis and antioxidative status.
Duration of the study is 3x three weeks including one wash-out week each followed by two
      weeks of juice/SSB consumption under free living conditions.

      During wash-out weeks consumption of orange juice or citrus fruits is restricted.

      During intervention weeks, participants are asked to eat three regular meals per day without
      snacking. Intervention weeks are (i) orange juice consumption with meals (ii) orange juice
      consumption between meals and (iii) SSB consumption between meals. Daily energy intake with
      orange juice/SSB is 20% of individual energy requirement. Additional caloric beverages (SSB,
      juice, coffee with sugar/milk, alcohol) are not allowed. At the beginning and the end of each
      intervention phase insulin sensitivity and antioxidative status are assessed.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: changes in daylong glycaemia between pre and post intervention periods
time frame: two weeks
description: measured via continuous glucose monitoring [mg/dL]
measure: changes in uric acid between pre and post intervention periods
time frame: two weeks
description: measured via uric acid serum levels [mg/dL]
measure: changes in insulin sensitivity between pre and post intervention periods
time frame: two weeks
description: measured via "Matsuda-Index" from oral glucose tolerance test data
measure: changes in antioxidative status between pre and post intervention periods
time frame: two weeks
description: measured via vitamin c blood levels [mg/L]
arm group label: Orange juice with meals
arm group type: Experimental
description: Effect of orange juice consumption with three meals per day (without snacking) on glucose metabolism and antioxidative status
arm group label: Orange juice between meals
arm group type: Experimental
description: Effect of orange juice consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status
arm group label: Sugar sweetened beverage between meals
arm group type: Experimental
description: Effect of sugar sweetened beverage consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status
intervention type: Dietary Supplement
intervention name: Orange juice with meals
description: orange juice (20% of energy requirement/day)
arm group label: Orange juice with meals
intervention type: Dietary Supplement
intervention name: Orange juice between meals
description: orange juice (20% of energy requirement/day)
arm group label: Orange juice between meals
intervention type: Dietary Supplement
intervention name: Sugar sweetened beverage between meals
description: Sugar sweetened beverage (20% of energy requirement/day)
arm group label: Sugar sweetened beverage between meals
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anja Bosy-Westphal, Prof PhD
role: Principal Investigator
affiliation: University of Hohenheim, Stuttgart, Germany
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No