<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/NCT03255876</url>
  </required_header>
  <id_info>
    <org_study_id>MEEC 16-011</org_study_id>
    <nct_id>NCT03255876</nct_id>
  </id_info>
  <brief_title>Effects of Enriched Fruit Juice on Blood Glucose Levels After a Meal in Healthy Subjects</brief_title>
  <acronym>PolyGlucHeal</acronym>
  <official_title>Effects of Enriched Fruit Juice on Blood Glucose Levels After a Meal in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leeds</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>
      Results from a large number of studies in humans have shown that diets rich in foods that&#xD;
      give lower glucose response bring lower risk of type 2 diabetes. Polyphenols, naturally found&#xD;
      in fruits, vegetables and grains, have shown the potential to attenuate post-prandial blood&#xD;
      glucose spikes following a carbohydrate-rich meal, through partial inhibition of the main&#xD;
      enzymes of carbohydrate digestion and reduction in glucose and fructose transport from the&#xD;
      gut after digestion and by enhancing the insulin action after glucose reaches the&#xD;
      bloodstream.&#xD;
&#xD;
      This study is designed to determine whether polyphenols, as normally and naturally present in&#xD;
      food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose&#xD;
      levels after its consumption, and hence lower its glycaemic index, and if this effect is&#xD;
      mediated through effects on insulin and other hormones. The study is designed as an acute,&#xD;
      double-blind, randomised, placebo-controlled crossover trial in 24 healthy subjects with&#xD;
      normal glycaemic response to white bread. Participants will be asked to consume either white&#xD;
      bread with pomegranate juice enriched with extracts from grape seeds and apple peels or white&#xD;
      bread with placebo drink. The effects on plasma glucose levels, levels of hormones and other&#xD;
      biomarkers involved in postprandial response will be determined over 3 hours after the&#xD;
      consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consumption of carbohydrate-rich foods or sugary drinks affects blood glucose levels. Results&#xD;
      from a large number of studies in humans have shown that diets rich in foods that give lower&#xD;
      glucose response beneficially affect elevated fasting blood glucose and insulin levels,&#xD;
      increase the sensitivity to insulin, contribute to the reduction of body weight and lipids&#xD;
      levels and ultimately bring lower risk of type 2 diabetes.&#xD;
&#xD;
      Blood glucose responses depend on the amount and type of carbohydrate(s) present in the meal.&#xD;
      Difference in post-prandial blood glucose response to different types of carbohydrates is&#xD;
      mainly due to the different rate of their digestion. However, response to the same&#xD;
      carbohydrate-rich food can be different between different individuals. Blood glucose levels&#xD;
      after carbohydrate-rich meal are shown to be significantly higher in subjects on high-fat&#xD;
      diet, in overweight or obese people, or in subjects with different levels of digestive&#xD;
      enzymes.&#xD;
&#xD;
      Results from in vitro studies indicate the potential of polyphenols, naturally found in&#xD;
      fruits, vegetables and grains, to attenuate post-prandial blood glucose spikes following a&#xD;
      carbohydrate-rich meal. It was previously shown that different polyphenols can slow down&#xD;
      carbohydrate digestion through partial inhibition of the main enzymes involved, can decrease&#xD;
      glucose and fructose transport from the gut after digestion and can improve the action of&#xD;
      insulin after glucose reaches the bloodstream.&#xD;
&#xD;
      In the previous study it was shown that pomegranate juice attenuates the increase in blood&#xD;
      glucose levels after a starchy meal. This effect is, at least partly, the result of hindered&#xD;
      starch digestion by polyphenols present in pomegranate juice.&#xD;
&#xD;
      The present study will determine whether polyphenols, as normally and naturally present in&#xD;
      food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose&#xD;
      levels after its consumption, and hence lower its glycaemic index, and if this effect is&#xD;
      mediated through effects on insulin and other hormones or determined by the individual levels&#xD;
      of digestive enzymes.&#xD;
&#xD;
      Healthy volunteers will be asked to consume two different meals: (1) white bread with&#xD;
      pomegranate juice enriched with extracts from grape seeds and apple peels or (2) white bread&#xD;
      with placebo drink with the same type and amount of carbohydrates and similar flavor as&#xD;
      enriched pomegranate juice, but without polyphenols.&#xD;
&#xD;
      The levels of glucose, insulin, gastric inhibitory polypeptide (GIP) and glucagon like&#xD;
      peptide-1 (GLP-1) will be measured in plasma isolated from blood samples obtained before and&#xD;
      up to 3 hours after the consumption of each meal. The levels of triglycerides and relevant&#xD;
      organic and fatty acids will also be determined.&#xD;
&#xD;
      Before recruitment volunteers will be screened for eligibility based on glucose levels, BMI&#xD;
      and glycemic response to white bread. Additional measurements taken at the screening will&#xD;
      include blood pressure values and blood lipids levels. All participants will be characterized&#xD;
      for the activity of salivary a-amylase and copies of a-amylase gene (AMY1).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 10, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 20, 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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within the intervention group vs. placebo control.</measure>
    <time_frame>Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.</time_frame>
    <description>The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120, 150 and 180 min) as the change in plasma glucose levels after the consumption of enriched pomegranate juice or placebo drink concomitantly with white bread, compared to the glucose levels before the consumption of test meals (baseline value, t=0min).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. placebo control.</measure>
    <time_frame>Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.</time_frame>
    <description>The glucose iAUC will be determined from all incremental plasma glucose levels at the defined time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 min) after the consumption of test and control meals based on trapezoid rule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. placebo control.</measure>
    <time_frame>Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.</time_frame>
    <description>Insulin levels measured at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma gastric inhibitory peptide (GIP) levels between baseline and endpoint within the intervention group vs. placebo control.</measure>
    <time_frame>Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.</time_frame>
    <description>GIP levels measured in plasma at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glucagon-like peptide-1 (GIP-1) levels between baseline and endpoint within the intervention group vs. placebo control.</measure>
    <time_frame>Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.</time_frame>
    <description>GLP-1 levels measured in plasma at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in organic acids profile between baseline and endpoint within the intervention group vs. placebo control.</measure>
    <time_frame>Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.</time_frame>
    <description>Levels of selected organic acids measured in plasma at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in fatty acids profile between baseline and endpoint within the intervention group vs. placebo control.</measure>
    <time_frame>Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.</time_frame>
    <description>Levels of selected free-fatty acids measured in serum at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in triglycerides levels between baseline and endpoint within the intervention group vs. placebo control.</measure>
    <time_frame>Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.</time_frame>
    <description>Levels of triglycerides measured in serum at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Hyperglycemia, Postprandial</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Enriched pomegranate juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will consume 200 ml of pure pomegranate juice enriched with grape seed and apple peel extracts concomitantly with 109 g of white bread</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo beverage</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will consume 200 ml of placebo drink concomitantly with 109 g of white bread</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Enriched pomegranate juice</intervention_name>
    <description>Pure pomegranate juice enriched with grape seed and apple peel extract (200 ml) to be consumed with 109 g of bread</description>
    <arm_group_label>Enriched pomegranate juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo beverage</intervention_name>
    <description>Beverage containing the same type and amount of carbohydrates as pomegranate juice and similar flavor (200 ml) to be consumed with 109 g of bread</description>
    <arm_group_label>Placebo beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fasting glucose ≤ 5.6 mM;&#xD;
&#xD;
          -  Body mass index (BMI) ≤ 30;&#xD;
&#xD;
          -  Max glucose after the consumption of app. 109g of white bread less than about 8-9 mM&#xD;
             (which is typical for the subjects we have measured previously);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking;&#xD;
&#xD;
          -  Participating in another trial that requires blood collection;&#xD;
&#xD;
          -  Diagnosed with any chronic illness (including diabetes, hypertension etc.);&#xD;
&#xD;
          -  On long term prescribed medication (except contraceptives);&#xD;
&#xD;
          -  Pregnant or lactating;&#xD;
&#xD;
          -  On a special diet or dietary regimen (for weight management or if regularly consuming&#xD;
             fruit extract supplements);&#xD;
&#xD;
          -  Allergy to fruits vegetables or pollen.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gary Williamson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aleksandra Konic Ristic, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gary Williamson, PhD</last_name>
    <phone>+441133438380</phone>
    <email>G.Williamson@leeds.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aleksandra Konic Ristic, PhD</last_name>
    <phone>+441133432979</phone>
    <email>A.KonicRistic@leeds.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>School of Food Science and Nutrition, University of Leeds</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS2 9JT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gary Williamson, PhD</last_name>
      <phone>+441133438380</phone>
      <email>G.Williamson@leeds.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Aleksandra Konic Ristic, PhD</last_name>
      <phone>+441133432979</phone>
      <email>a.konicristic@leeds.ac.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Aleksandra Konic Ristic, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hilda Nyambe, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Asimina Kerimi, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sarka Tumova, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>June 27, 2018</last_update_submitted>
  <last_update_submitted_qc>June 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Gary Williamson</investigator_full_name>
    <investigator_title>Professor Gary Williamson</investigator_title>
  </responsible_party>
  <keyword>Polyphenols</keyword>
  <keyword>Hyperglycemia</keyword>
  <keyword>Postprandial</keyword>
  <keyword>Starch</keyword>
  <keyword>Alpha-amylase</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03255876
org study id: MEEC 16-011
nct id: NCT03255876
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Results from a large number of studies in humans have shown that diets rich in foods that
      give lower glucose response bring lower risk of type 2 diabetes. Polyphenols, naturally found
      in fruits, vegetables and grains, have shown the potential to attenuate post-prandial blood
      glucose spikes following a carbohydrate-rich meal, through partial inhibition of the main
      enzymes of carbohydrate digestion and reduction in glucose and fructose transport from the
      gut after digestion and by enhancing the insulin action after glucose reaches the
      bloodstream.

      This study is designed to determine whether polyphenols, as normally and naturally present in
      food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose
      levels after its consumption, and hence lower its glycaemic index, and if this effect is
      mediated through effects on insulin and other hormones. The study is designed as an acute,
      double-blind, randomised, placebo-controlled crossover trial in 24 healthy subjects with
      normal glycaemic response to white bread. Participants will be asked to consume either white
      bread with pomegranate juice enriched with extracts from grape seeds and apple peels or white
      bread with placebo drink. The effects on plasma glucose levels, levels of hormones and other
      biomarkers involved in postprandial response will be determined over 3 hours after the
      consumption.
Consumption of carbohydrate-rich foods or sugary drinks affects blood glucose levels. Results
      from a large number of studies in humans have shown that diets rich in foods that give lower
      glucose response beneficially affect elevated fasting blood glucose and insulin levels,
      increase the sensitivity to insulin, contribute to the reduction of body weight and lipids
      levels and ultimately bring lower risk of type 2 diabetes.

      Blood glucose responses depend on the amount and type of carbohydrate(s) present in the meal.
      Difference in post-prandial blood glucose response to different types of carbohydrates is
      mainly due to the different rate of their digestion. However, response to the same
      carbohydrate-rich food can be different between different individuals. Blood glucose levels
      after carbohydrate-rich meal are shown to be significantly higher in subjects on high-fat
      diet, in overweight or obese people, or in subjects with different levels of digestive
      enzymes.

      Results from in vitro studies indicate the potential of polyphenols, naturally found in
      fruits, vegetables and grains, to attenuate post-prandial blood glucose spikes following a
      carbohydrate-rich meal. It was previously shown that different polyphenols can slow down
      carbohydrate digestion through partial inhibition of the main enzymes involved, can decrease
      glucose and fructose transport from the gut after digestion and can improve the action of
      insulin after glucose reaches the bloodstream.

      In the previous study it was shown that pomegranate juice attenuates the increase in blood
      glucose levels after a starchy meal. This effect is, at least partly, the result of hindered
      starch digestion by polyphenols present in pomegranate juice.

      The present study will determine whether polyphenols, as normally and naturally present in
      food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose
      levels after its consumption, and hence lower its glycaemic index, and if this effect is
      mediated through effects on insulin and other hormones or determined by the individual levels
      of digestive enzymes.

      Healthy volunteers will be asked to consume two different meals: (1) white bread with
      pomegranate juice enriched with extracts from grape seeds and apple peels or (2) white bread
      with placebo drink with the same type and amount of carbohydrates and similar flavor as
      enriched pomegranate juice, but without polyphenols.

      The levels of glucose, insulin, gastric inhibitory polypeptide (GIP) and glucagon like
      peptide-1 (GLP-1) will be measured in plasma isolated from blood samples obtained before and
      up to 3 hours after the consumption of each meal. The levels of triglycerides and relevant
      organic and fatty acids will also be determined.

      Before recruitment volunteers will be screened for eligibility based on glucose levels, BMI
      and glycemic response to white bread. Additional measurements taken at the screening will
      include blood pressure values and blood lipids levels. All participants will be characterized
      for the activity of salivary a-amylase and copies of a-amylase gene (AMY1).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within the intervention group vs. placebo control.
time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
description: The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120, 150 and 180 min) as the change in plasma glucose levels after the consumption of enriched pomegranate juice or placebo drink concomitantly with white bread, compared to the glucose levels before the consumption of test meals (baseline value, t=0min).
measure: Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. placebo control.
time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
description: The glucose iAUC will be determined from all incremental plasma glucose levels at the defined time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 min) after the consumption of test and control meals based on trapezoid rule.
measure: Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. placebo control.
time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
description: Insulin levels measured at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.
measure: Changes in plasma gastric inhibitory peptide (GIP) levels between baseline and endpoint within the intervention group vs. placebo control.
time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
description: GIP levels measured in plasma at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.
measure: Changes in glucagon-like peptide-1 (GIP-1) levels between baseline and endpoint within the intervention group vs. placebo control.
time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
description: GLP-1 levels measured in plasma at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.
measure: Changes in organic acids profile between baseline and endpoint within the intervention group vs. placebo control.
time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
description: Levels of selected organic acids measured in plasma at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.
measure: Changes in fatty acids profile between baseline and endpoint within the intervention group vs. placebo control.
time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
description: Levels of selected free-fatty acids measured in serum at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.
measure: Changes in triglycerides levels between baseline and endpoint within the intervention group vs. placebo control.
time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
description: Levels of triglycerides measured in serum at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.
arm group label: Enriched pomegranate juice
arm group type: Experimental
description: Participants will consume 200 ml of pure pomegranate juice enriched with grape seed and apple peel extracts concomitantly with 109 g of white bread
arm group label: Placebo beverage
arm group type: Placebo Comparator
description: Participants will consume 200 ml of placebo drink concomitantly with 109 g of white bread
intervention type: Dietary Supplement
intervention name: Enriched pomegranate juice
description: Pure pomegranate juice enriched with grape seed and apple peel extract (200 ml) to be consumed with 109 g of bread
arm group label: Enriched pomegranate juice
intervention type: Dietary Supplement
intervention name: Placebo beverage
description: Beverage containing the same type and amount of carbohydrates as pomegranate juice and similar flavor (200 ml) to be consumed with 109 g of bread
arm group label: Placebo beverage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gary Williamson, PhD
role: Study Chair
affiliation: University of Leeds
last name: Aleksandra Konic Ristic, PhD
role: Principal Investigator
affiliation: University of Leeds
last name: Gary Williamson, PhD
phone: +441133438380
email: G.Williamson@leeds.ac.uk
last name: Aleksandra Konic Ristic, PhD
phone: +441133432979
email: A.KonicRistic@leeds.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Leeds
investigator full name: Gary Williamson
investigator title: Professor Gary Williamson
mesh term: Hyperglycemia
sharing ipd: Yes