<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/NCT03769389</url>
  </required_header>
  <id_info>
    <org_study_id>DFGI</org_study_id>
    <nct_id>NCT03769389</nct_id>
  </id_info>
  <brief_title>Assessing the Glycaemic Index of Two Different Cultivars of Date Fruit</brief_title>
  <official_title>Assessing the Glycaemic Index of Two Different Cultivars of Date Fruit When Mixed With 0% Fat Yogurt on Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Newcastle 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>
      Fruit of the date palm (P. dactylifera) may be considered as an emerging and potential&#xD;
      candidate for the development of health-promoting foods, owing to its high nutritional&#xD;
      values.&#xD;
&#xD;
      Furthermore, aqueous extracts of dates have previously been shown to have potent antioxidant&#xD;
      activity, because they inhibit in vitro lipid and protein oxidation and possess free radical&#xD;
      scavenging capacity.&#xD;
&#xD;
      Although the high sugar content of date fruit has always been a concern, date fruit has been&#xD;
      regarded as a low-GI to medium-GI food. However, very limited, inconsistent and contradictory&#xD;
      information is available on the glycaemic index values of different date varieties, which may&#xD;
      be attributed to both the methodology as well as other food factors. Date consumption is high&#xD;
      among people of Arabic origin, where it's very common for them to be eaten with coffee or&#xD;
      yoghurt. Therefore, in view of these concerns, the objective of this trial is to evaluate the&#xD;
      glycaemic response of two different varieties of dates, named Birhi &amp; Khassab, in an early&#xD;
      maturation stage (Rutab stage), when mixed with 0% fat yogurt, on ten healthy participants&#xD;
      aged between 18 and 45.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Although, the fruit of the date palm (P. dactylifera) may be considered an&#xD;
      emerging and potential candidate for the development of health-promoting foods owing to its&#xD;
      high nutritive values,the high sugar content of date fruit has always been a concern.&#xD;
      Sun-dried dates, which is the well-known ripening stage of date fruit, can be regarded as&#xD;
      low-GI to medium-GI food. However, very limited, inconsistent and contradictory information&#xD;
      is available on the glycaemic Index values of different date varieties. This variation could&#xD;
      be attributed to either the methodology or the food factors.&#xD;
&#xD;
      Rational and objective Nowadays, low-GI foods have often been found to induce beneficial&#xD;
      effects on risk factors for certain non-communicable chronic diseases . As the chemical&#xD;
      composition of dates can vary depending on cultivar, soil conditions, agronomic practices as&#xD;
      well as the ripening stage. It is important to know the GI of the local/regional date&#xD;
      varieties, and in different date products such as dates with yoghurt. Date consumption is&#xD;
      high among people of Arabic origin, where it is very commonly eaten with coffee or yoghurt.&#xD;
      During the first trial of this PHD project, treatments containing 150g of 0% fat yoghurt and&#xD;
      two different freeze dried date powders, depending on if it was a Birhi treatment or Khassab&#xD;
      treatment, were formulated. These were used to assess acute effects of date fruit and yoghurt&#xD;
      on mood and cognitive performance in healthy volunteers, as per the ethical approval from&#xD;
      Newcastle University. These exact treatments will be used again, and the trial will aim to&#xD;
      evaluate their glycaemic index on 10 healthy participants.&#xD;
&#xD;
      Participants Ten healthy participants aged between 18 and 45 will be recruited. Participants&#xD;
      will be required to undergo a screening visit, followed by three study visits, which will&#xD;
      last 2:15 minutes for each visit. Glycaemic indexes will be calculated using standard&#xD;
      methods. Results will be calculated using means and standard deviations.&#xD;
&#xD;
      Design&#xD;
&#xD;
      A standard experimental study involving the measurement of the glycaemic responses of the&#xD;
      ingestion of two different varieties of dates, when mixed with 0% fat yoghurt, and a placebo&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2018</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose concentrations (mml/15 min)after the consumption Birhi</measure>
    <time_frame>Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose</time_frame>
    <description>On each of the study days, blood glucose will be measured at baseline, 15 min post-dose, 30 min post-dose, 45 min post-dose, 60 min post-dose, 75 min post-dose, 90 min post-dose, 105 min post-dose and 120 min post- dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood glucose concentrations (mml/15 min)after the consumption Khassab</measure>
    <time_frame>Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose</time_frame>
    <description>On each of the study days, blood glucose will be measured at baseline, 15 min post-dose, 30 min post-dose, 45 min post-dose, 60 min post-dose, 75 min post-dose, 90 min post-dose, 105 min post-dose and 120 min post- dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood glucose concentrations (mml/15 min)after the consumption Placebo</measure>
    <time_frame>Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose</time_frame>
    <description>On each of the study days, blood glucose will be measured at baseline, 15 min post-dose, 30 min post-dose, 45 min post-dose, 60 min post-dose, 75 min post-dose, 90 min post-dose, 105 min post-dose and 120 min post- dose.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>GI Glycaemic Index Healthy Volunteers</condition>
  <condition>GL Glycaemic Load Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>assessing the GI + GL of Birhi + YEO 0% fat yoghurt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>47g of total carbohydrate in which contains 43.6g of Freeze-dried of Birhi powder+ 150g of 0% fat yoghurt</description>
  </arm_group>
  <arm_group>
    <arm_group_label>assessing the GI + GL of Khassab + YEO 0% fat yoghurt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>47g of total carbohydrate in which contains34.6g of freeze-dried Khassab powder+ 150g of 0% fat yoghurt</description>
  </arm_group>
  <arm_group>
    <arm_group_label>assessing the GI + GL of 50g of Glucose in 100 ml of water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50g of pure glucose dissolved in 100ml of water</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Birhi</intervention_name>
    <description>Birhi which contain the following:&#xD;
43.6g of Freeze-dried date powder+ 150g of 0% fat yoghurt</description>
    <arm_group_label>assessing the GI + GL of 50g of Glucose in 100 ml of water</arm_group_label>
    <arm_group_label>assessing the GI + GL of Birhi + YEO 0% fat yoghurt</arm_group_label>
    <arm_group_label>assessing the GI + GL of Khassab + YEO 0% fat yoghurt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Khassab</intervention_name>
    <description>34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt</description>
    <arm_group_label>assessing the GI + GL of 50g of Glucose in 100 ml of water</arm_group_label>
    <arm_group_label>assessing the GI + GL of Birhi + YEO 0% fat yoghurt</arm_group_label>
    <arm_group_label>assessing the GI + GL of Khassab + YEO 0% fat yoghurt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>50g of pure glucose dissolved in 100ml of water</description>
    <arm_group_label>assessing the GI + GL of 50g of Glucose in 100 ml of water</arm_group_label>
    <arm_group_label>assessing the GI + GL of Birhi + YEO 0% fat yoghurt</arm_group_label>
    <arm_group_label>assessing the GI + GL of Khassab + YEO 0% fat yoghurt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants A total of 10 healthy participants aged between 18 and 45 will be&#xD;
             recruited through advertisement via poster and flyer. This is an internationally&#xD;
             recognised standard protocol which recommends using 10 volunteers or replicates for&#xD;
             each foodstuff, and all participants will be required to undergo a screening visit.&#xD;
&#xD;
        Inclusion Criteria Healthy participants aged 18-45 with a BMI &gt;18 &lt;36 will be recruited&#xD;
        from the Newcastle Upon-Tyne area.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants will be considered ineligible to participate in the study if they meet any of&#xD;
        the following criteria:&#xD;
&#xD;
          1. They have any metabolic diseases such as type 1 or type 2 diabetes.&#xD;
&#xD;
          2. They have a BMI above 35kg/m2 or lower than 18kg/m2&#xD;
&#xD;
          3. They are taking any illicit or prescribed drugs.&#xD;
&#xD;
          4. They are using dietary supplements, over the counter medicine or recreational drugs&#xD;
&#xD;
          5. They are females who are pregnant or seeking to become pregnant.&#xD;
&#xD;
          6. They have allergies to any food products.&#xD;
&#xD;
          7. They have any dairy intolerances.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NU-Food Research Facility</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <state>Tyne And Wear</state>
        <zip>NE1 7RU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>March 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03769389
org study id: DFGI
nct id: NCT03769389
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Fruit of the date palm (P. dactylifera) may be considered as an emerging and potential
      candidate for the development of health-promoting foods, owing to its high nutritional
      values.

      Furthermore, aqueous extracts of dates have previously been shown to have potent antioxidant
      activity, because they inhibit in vitro lipid and protein oxidation and possess free radical
      scavenging capacity.

      Although the high sugar content of date fruit has always been a concern, date fruit has been
      regarded as a low-GI to medium-GI food. However, very limited, inconsistent and contradictory
      information is available on the glycaemic index values of different date varieties, which may
      be attributed to both the methodology as well as other food factors. Date consumption is high
      among people of Arabic origin, where it's very common for them to be eaten with coffee or
      yoghurt. Therefore, in view of these concerns, the objective of this trial is to evaluate the
      glycaemic response of two different varieties of dates, named Birhi & Khassab, in an early
      maturation stage (Rutab stage), when mixed with 0% fat yogurt, on ten healthy participants
      aged between 18 and 45.
Introduction Although, the fruit of the date palm (P. dactylifera) may be considered an
      emerging and potential candidate for the development of health-promoting foods owing to its
      high nutritive values,the high sugar content of date fruit has always been a concern.
      Sun-dried dates, which is the well-known ripening stage of date fruit, can be regarded as
      low-GI to medium-GI food. However, very limited, inconsistent and contradictory information
      is available on the glycaemic Index values of different date varieties. This variation could
      be attributed to either the methodology or the food factors.

      Rational and objective Nowadays, low-GI foods have often been found to induce beneficial
      effects on risk factors for certain non-communicable chronic diseases . As the chemical
      composition of dates can vary depending on cultivar, soil conditions, agronomic practices as
      well as the ripening stage. It is important to know the GI of the local/regional date
      varieties, and in different date products such as dates with yoghurt. Date consumption is
      high among people of Arabic origin, where it is very commonly eaten with coffee or yoghurt.
      During the first trial of this PHD project, treatments containing 150g of 0% fat yoghurt and
      two different freeze dried date powders, depending on if it was a Birhi treatment or Khassab
      treatment, were formulated. These were used to assess acute effects of date fruit and yoghurt
      on mood and cognitive performance in healthy volunteers, as per the ethical approval from
      Newcastle University. These exact treatments will be used again, and the trial will aim to
      evaluate their glycaemic index on 10 healthy participants.

      Participants Ten healthy participants aged between 18 and 45 will be recruited. Participants
      will be required to undergo a screening visit, followed by three study visits, which will
      last 2:15 minutes for each visit. Glycaemic indexes will be calculated using standard
      methods. Results will be calculated using means and standard deviations.

      Design

      A standard experimental study involving the measurement of the glycaemic responses of the
      ingestion of two different varieties of dates, when mixed with 0% fat yoghurt, and a placebo
      treatment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Blood glucose concentrations (mml/15 min)after the consumption Birhi
time frame: Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose
description: On each of the study days, blood glucose will be measured at baseline, 15 min post-dose, 30 min post-dose, 45 min post-dose, 60 min post-dose, 75 min post-dose, 90 min post-dose, 105 min post-dose and 120 min post- dose.
measure: Blood glucose concentrations (mml/15 min)after the consumption Khassab
time frame: Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose
description: On each of the study days, blood glucose will be measured at baseline, 15 min post-dose, 30 min post-dose, 45 min post-dose, 60 min post-dose, 75 min post-dose, 90 min post-dose, 105 min post-dose and 120 min post- dose.
measure: Blood glucose concentrations (mml/15 min)after the consumption Placebo
time frame: Change from baseline BG level at minute 15,30,45,60,75,90,105, 120 post dose
description: On each of the study days, blood glucose will be measured at baseline, 15 min post-dose, 30 min post-dose, 45 min post-dose, 60 min post-dose, 75 min post-dose, 90 min post-dose, 105 min post-dose and 120 min post- dose.
arm group label: assessing the GI + GL of Birhi + YEO 0% fat yoghurt
arm group type: Experimental
description: 47g of total carbohydrate in which contains 43.6g of Freeze-dried of Birhi powder+ 150g of 0% fat yoghurt
arm group label: assessing the GI + GL of Khassab + YEO 0% fat yoghurt
arm group type: Experimental
description: 47g of total carbohydrate in which contains34.6g of freeze-dried Khassab powder+ 150g of 0% fat yoghurt
arm group label: assessing the GI + GL of 50g of Glucose in 100 ml of water
arm group type: Experimental
description: 50g of pure glucose dissolved in 100ml of water
intervention type: Dietary Supplement
intervention name: Birhi
description: Birhi which contain the following:
43.6g of Freeze-dried date powder+ 150g of 0% fat yoghurt
arm group label: assessing the GI + GL of 50g of Glucose in 100 ml of water
arm group label: assessing the GI + GL of Birhi + YEO 0% fat yoghurt
arm group label: assessing the GI + GL of Khassab + YEO 0% fat yoghurt
intervention type: Dietary Supplement
intervention name: Khassab
description: 34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt
arm group label: assessing the GI + GL of 50g of Glucose in 100 ml of water
arm group label: assessing the GI + GL of Birhi + YEO 0% fat yoghurt
arm group label: assessing the GI + GL of Khassab + YEO 0% fat yoghurt
intervention type: Dietary Supplement
intervention name: placebo
description: 50g of pure glucose dissolved in 100ml of water
arm group label: assessing the GI + GL of 50g of Glucose in 100 ml of water
arm group label: assessing the GI + GL of Birhi + YEO 0% fat yoghurt
arm group label: assessing the GI + GL of Khassab + YEO 0% fat yoghurt
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided