<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/NCT01706653</url>
  </required_header>
  <id_info>
    <org_study_id>TSB101118</org_study_id>
    <secondary_id>12681-83204</secondary_id>
    <nct_id>NCT01706653</nct_id>
  </id_info>
  <brief_title>The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health</brief_title>
  <official_title>Fruit Polyphenols: Maximising Knowledge of Their Metabolic Health Benefits and Practical Applications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lucozade Ribena Suntory</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether consumption of the active product affects&#xD;
      postprandial changes in metabolic indices, in comparison to the control product.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Healthy Men and Women</condition>
  <arm_group>
    <arm_group_label>Intervention 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Polyphenol-enriched fruit-based drink - low</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Polyphenol-enriched fruit-based drink - medium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Polyphenol-enriched fruit-based drink - high</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 4</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Very low polyphenol fruit based drink (control)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Polyphenol-enriched fruit-based drink - low</intervention_name>
    <arm_group_label>Intervention 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Polyphenol-enriched fruit-based drink - medium</intervention_name>
    <arm_group_label>Intervention 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Polyphenol-enriched fruit-based drink - high</intervention_name>
    <arm_group_label>Intervention 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Very low polyphenol fruit based drink (control)</intervention_name>
    <arm_group_label>Intervention 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy free-living men aged from 20 to 60 years old, and postmenopausal women aged&#xD;
             from 45 to 60 years old, on the day of inclusion&#xD;
&#xD;
          -  Able to understand the information sheet and comply with all the trial procedures&#xD;
&#xD;
          -  Having given written consent to take part in the study prior to participation.&#xD;
&#xD;
          -  Body mass index (BMI): 18.0 - 35 kg/m².&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those diagnosed with Phenylketonuria (PKU)&#xD;
&#xD;
          -  Those with known or suspected food intolerances, allergies or hypersensitivity&#xD;
&#xD;
          -  Women who are known to be pregnant or who are intending to become pregnant over the&#xD;
             course of the study&#xD;
&#xD;
          -  Women who are breast feeding&#xD;
&#xD;
          -  Participation in another clinical trial&#xD;
&#xD;
          -  Those who have donated blood within 3 months of the screening visit and participants&#xD;
             for whom participation in this study would result in having donated more than 1500&#xD;
             millilitres of blood in the previous 12 months&#xD;
&#xD;
          -  Those with Full Blood Counts and Liver Function test results outside of the normal&#xD;
             range&#xD;
&#xD;
          -  Pre-menopausal women due to the potential influence of cyclical changes in&#xD;
             reproductive hormones on insulin sensitivity&#xD;
&#xD;
          -  Current smokers, or reported giving up smoking within the last 6 months&#xD;
&#xD;
          -  History of substance abuse or alcoholism&#xD;
&#xD;
          -  Reported history of CVD, diabetes (or fasting glucose ≥ 7.1 mmol/L), cancer, kidney,&#xD;
             liver or bowel disease, gastrointestinal disorder or use of drug likely to alter&#xD;
             gastrointestinal function&#xD;
&#xD;
          -  Unwilling to restrict consumption of specified high polyphenol foods for 24 h before&#xD;
             the study&#xD;
&#xD;
          -  Weight loss &gt;3kg in preceding 2 months and body mass index &lt;18 or &gt;35 kg/m²&#xD;
&#xD;
          -  Blood pressure ≥160/100 mmHg&#xD;
&#xD;
          -  Total cholesterol ≥ 7.5 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L&#xD;
&#xD;
          -  Medications that may interfere with the study such as alpha-glucosidase inhibitors&#xD;
             (e.g. acarbose), insulin-sensitising drugs (e.g. metformin, thiazolidinediones),&#xD;
             sulfonylureas, and lipid-lowering drugs. Other medications, should be reviewed by&#xD;
             medical representative from KCL on a case by case basis.&#xD;
&#xD;
          -  Nutritional supplements that may interfere with the study such as higher dose&#xD;
             vitamins/minerals (&gt;200% RNI), B vitamins, Vitamin C, calcium, copper, chromium,&#xD;
             iodine, iron, magnesium, manganese, phosphorus, potassium and zinc. Subjects already&#xD;
             taking vitamin or minerals at a dose around 100 % or less up to 200% of the RNI, or&#xD;
             evening primrose/algal/fish oil supplements will be asked to maintain habitual intake&#xD;
             patterns, ensuring that they take them every day and not sporadically. They will be&#xD;
             advised not to stop taking supplements or start taking new supplements during the&#xD;
             course of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Diabetes &amp; Nutritional Sciences Division, School of Medicine, King's College London</name>
      <address>
        <city>London</city>
        <zip>SE1 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/27764725</url>
    <description>Primary publication</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King's College London</investigator_affiliation>
    <investigator_full_name>Dr Wendy Hall</investigator_full_name>
    <investigator_title>Lecturer in Nutritional Sciences</investigator_title>
  </responsible_party>
  <keyword>Polyphenol</keyword>
  <keyword>Fruit</keyword>
  <keyword>Metabolic</keyword>
  <keyword>Healthy</keyword>
  <!-- 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/NCT01706653
org study id: TSB101118
secondary id: 12681-83204
nct id: NCT01706653
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether consumption of the active product affects
      postprandial changes in metabolic indices, in comparison to the control product.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
arm group label: Intervention 1
arm group type: Active Comparator
description: Polyphenol-enriched fruit-based drink - low
arm group label: Intervention 2
arm group type: Active Comparator
description: Polyphenol-enriched fruit-based drink - medium
arm group label: Intervention 3
arm group type: Active Comparator
description: Polyphenol-enriched fruit-based drink - high
arm group label: Intervention 4
arm group type: Placebo Comparator
description: Very low polyphenol fruit based drink (control)
intervention type: Dietary Supplement
intervention name: Polyphenol-enriched fruit-based drink - low
arm group label: Intervention 1
intervention type: Dietary Supplement
intervention name: Polyphenol-enriched fruit-based drink - medium
arm group label: Intervention 2
intervention type: Dietary Supplement
intervention name: Polyphenol-enriched fruit-based drink - high
arm group label: Intervention 3
intervention type: Dietary Supplement
intervention name: Very low polyphenol fruit based drink (control)
arm group label: Intervention 4
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
url: http://www.ncbi.nlm.nih.gov/pubmed/27764725
description: Primary publication
responsible party type: Principal Investigator
investigator affiliation: King's College London
investigator full name: Dr Wendy Hall
investigator title: Lecturer in Nutritional Sciences