<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/NCT04412798</url>
  </required_header>
  <id_info>
    <org_study_id>Orange -Juice-001</org_study_id>
    <nct_id>NCT04412798</nct_id>
  </id_info>
  <brief_title>Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus</brief_title>
  <official_title>Impact of Orange Juice During Breakfast on Glycaemic Control in Individuals With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hochschule Geisenheim University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt 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 evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly&#xD;
      variable and largely out-of-date, with a few studies reporting acute negative glycaemic&#xD;
      effects when 100% orange juice is drunk with or without a meal. The aim of the project is to&#xD;
      study the impact of the intake of a single serving of 100% orange juice on glycaemic control&#xD;
      in male patients with pre-existing type 2 diabetes mellitus. In addition, immunological&#xD;
      parameters and Alzheimer disease related biomarkers will be assessed to examine the chronic&#xD;
      inflammatory state of these patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycaemic responses venous blood</measure>
    <time_frame>baseline</time_frame>
    <description>Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycaemic responses venous blood</measure>
    <time_frame>Day 5</time_frame>
    <description>Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycaemic responses venous blood</measure>
    <time_frame>Day 10</time_frame>
    <description>Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin responses</measure>
    <time_frame>Baseline</time_frame>
    <description>Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin responses</measure>
    <time_frame>Day 5</time_frame>
    <description>Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin responses</measure>
    <time_frame>Day 10</time_frame>
    <description>Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Capillary glycaemic responses</measure>
    <time_frame>Baseline</time_frame>
    <description>Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Capillary glycaemic responses</measure>
    <time_frame>Day 5</time_frame>
    <description>Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Capillary glycaemic responses</measure>
    <time_frame>Day 10</time_frame>
    <description>Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycated haemoglobin measure</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured on a single blood sample to characterize patients' overall glycaemic contro</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flow cytometry</measure>
    <time_frame>Baseline</time_frame>
    <description>Fasting venous blood samples collected to examine Peripheral blood mononuclear cells (flow cytometry) to measure immunological parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alzheimer disease related biomarkers</measure>
    <time_frame>Baseline</time_frame>
    <description>Blood samples will be collected every 30 min for 5 hours to examine Alzheimer disease relevant biomarkers (Abeta42, Abeta40, Tau, p-Tau, neuroinflammatory markers and other)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>Baseline</time_frame>
    <description>body weight/height (to determine BMI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist/hip circumference (Body composition)</measure>
    <time_frame>Baseline</time_frame>
    <description>Waist/hip circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic/diastolic blood pressure</measure>
    <time_frame>Baseline</time_frame>
    <description>Systolic/diastolic blood pressure</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>orange juice concentrate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sugar-sweetened orange-flavoured beverage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Whole orange juice with skin removed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>orange juice concentrate</intervention_name>
    <description>250mL of 100% orange juice made from concentrate</description>
    <arm_group_label>group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sugar-sweetened orange-flavoured beverage</intervention_name>
    <description>Sugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole orange juice with skin removed</intervention_name>
    <description>Whole orange pieces with skin removed, energy-matched to the orange juice condition</description>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria: Male individuals (aged 25-65 years) with up to 8 years of T2DM,&#xD;
             according to ADA criteria (Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during&#xD;
             OGTT. The test should be performed as described by the WHO, using a glucose load&#xD;
             containing the equivalent of 75-g anhydrous glucose dissolved in water; or HbA1c &gt;&#xD;
             ≥6.5% (48 mmol/mol)).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participants on exogenous insulin therapy,&#xD;
&#xD;
          -  HbA1c &gt;8.5%,&#xD;
&#xD;
          -  BMI &lt;27 or &gt;33 kg/m²,&#xD;
&#xD;
          -  regular smokers (&gt;1 cigarette per day),&#xD;
&#xD;
          -  participants with established cardiovascular disease,&#xD;
&#xD;
          -  neurological disease,&#xD;
&#xD;
          -  cancer,&#xD;
&#xD;
          -  renal disease.&#xD;
&#xD;
          -  Participants who are unwilling to consume any of the standard foods/drinks&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominique Hansen, prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dominique Hansen, prof. dr.</last_name>
    <phone>+32 11 29 21 26</phone>
    <email>dominique.hansen@uhasselt.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kenneth Verboven, dr.</last_name>
    <phone>+32 11 28 69 49</phone>
    <email>kenneth.verboven@uhasselt.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hasselt University</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique Hansen, prof. dr.</last_name>
      <phone>+32 11 29 21 26</phone>
      <email>dominique.hansen@uhasselt.be</email>
    </contact>
    <investigator>
      <last_name>Dominique Hansen, prof. dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>Dominique Hansen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04412798
org study id: Orange -Juice-001
nct id: NCT04412798
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly
      variable and largely out-of-date, with a few studies reporting acute negative glycaemic
      effects when 100% orange juice is drunk with or without a meal. The aim of the project is to
      study the impact of the intake of a single serving of 100% orange juice on glycaemic control
      in male patients with pre-existing type 2 diabetes mellitus. In addition, immunological
      parameters and Alzheimer disease related biomarkers will be assessed to examine the chronic
      inflammatory state of these patients
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Glycaemic responses venous blood
time frame: baseline
description: Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
measure: Glycaemic responses venous blood
time frame: Day 5
description: Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
measure: Glycaemic responses venous blood
time frame: Day 10
description: Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
measure: Insulin responses
time frame: Baseline
description: Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
measure: Insulin responses
time frame: Day 5
description: Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
measure: Insulin responses
time frame: Day 10
description: Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
measure: Capillary glycaemic responses
time frame: Baseline
description: Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
measure: Capillary glycaemic responses
time frame: Day 5
description: Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
measure: Capillary glycaemic responses
time frame: Day 10
description: Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
measure: Glycated haemoglobin measure
time frame: Baseline
description: Measured on a single blood sample to characterize patients' overall glycaemic contro
measure: Flow cytometry
time frame: Baseline
description: Fasting venous blood samples collected to examine Peripheral blood mononuclear cells (flow cytometry) to measure immunological parameters
measure: Alzheimer disease related biomarkers
time frame: Baseline
description: Blood samples will be collected every 30 min for 5 hours to examine Alzheimer disease relevant biomarkers (Abeta42, Abeta40, Tau, p-Tau, neuroinflammatory markers and other)
measure: BMI
time frame: Baseline
description: body weight/height (to determine BMI)
measure: Waist/hip circumference (Body composition)
time frame: Baseline
description: Waist/hip circumference
measure: Systolic/diastolic blood pressure
time frame: Baseline
description: Systolic/diastolic blood pressure
arm group label: group 1
arm group type: Other
description: orange juice concentrate
arm group label: Group 2
arm group type: Other
description: Sugar-sweetened orange-flavoured beverage
arm group label: Group 3
arm group type: Other
description: Whole orange juice with skin removed
intervention type: Other
intervention name: orange juice concentrate
description: 250mL of 100% orange juice made from concentrate
arm group label: group 1
intervention type: Other
intervention name: Sugar-sweetened orange-flavoured beverage
description: Sugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition
arm group label: Group 2
intervention type: Other
intervention name: Whole orange juice with skin removed
description: Whole orange pieces with skin removed, energy-matched to the orange juice condition
arm group label: Group 3
criteria: 
gender: Male
gender based: Yes
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dominique Hansen, prof. dr.
role: Principal Investigator
affiliation: Hasselt University
last name: Dominique Hansen, prof. dr.
phone: +32 11 29 21 26
email: dominique.hansen@uhasselt.be
last name: Kenneth Verboven, dr.
phone: +32 11 28 69 49
email: kenneth.verboven@uhasselt.be
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Dominique Hansen
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2