<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/NCT01729949</url>
  </required_header>
  <id_info>
    <org_study_id>PPF 2012-073</org_study_id>
    <nct_id>NCT01729949</nct_id>
  </id_info>
  <brief_title>The Acute and Chronic Effects of Fruit Polyphenols on Chronic Disease (PPF)</brief_title>
  <official_title>A Randomized Placebo Controlled Trial to Test the Acute and Chronic Effects of Fruit Polyphenols on Postprandial Indices of Chronic Disease (PPF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Nutrition Research Center, Illinois Institute of Technology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinical Nutrition Research Center, Illinois Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. The primary objective is to determine the effect of fruit polyphenols on postprandial&#xD;
           lipoprotein triglyceride metabolism after consumption a standard high carbohydrate/fat&#xD;
           breakfast meal with a beverage rich in fruit-derived polyphenols compared to energy and&#xD;
           macro-/micro-nutrient matched control beverage (acute, Part 1).&#xD;
&#xD;
        2. Secondary objectives are: 1)to assess the effects of consuming daily for 8 weeks&#xD;
           (chronic, Part 2) a beverage rich in fruit polyphenols compared to an energy and&#xD;
           macro-/micro- nutrient matched control beverage on fasting glucose, insulin, lipids and&#xD;
           markers of oxidative stress; and 2) to assess the effects of these beverages on&#xD;
           meal-related changes in metabolic and oxidative stress measures after 8 weeks daily&#xD;
           consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a single-center, double-blinded, randomized, 2-part, 2-arm, 4-sequence,&#xD;
      crossover study that incorporates both the acute and chronic evaluations of fruit polyphenols&#xD;
      on metabolic indices and markers of oxidative stress.&#xD;
&#xD;
      A planned sample size of 30 overweight men and women will be recruited into the study.&#xD;
      Subjects will be required to meet several inclusion and exclusion criteria, which will be&#xD;
      assessed through online and clinic screening mechanisms, including questionnaires, blood&#xD;
      analysis, and anthropometric measurements. Eligible subjects will be invited to participate&#xD;
      in the study. Subjects will begin by completing a 7-day pre-study assessment of their usual&#xD;
      dietary intake using 3-day food diary followed by washout of dietary polyphenols. Subjects&#xD;
      will participate in 4, 6 h postprandial study days: 2 preceding the chronic intervention and&#xD;
      2 after 8 weeks each of active (fruit polyphenols) and placebo beverages. Subjects will be&#xD;
      randomized on the first day of starting the acute and chronic study phases. Subjects will be&#xD;
      asked to limit polyphenolic containing foods and beverages for 3 days prior to each 6 h&#xD;
      postprandial study visit as well through the chronic dietary intervention. Subjects will be&#xD;
      provided a standardized dinner meal pack on the day before each 6 h postprandial visit.&#xD;
&#xD;
      For each 6 h postprandial study visit, subjects will arrive fasted and follow procedures&#xD;
      published by our lab previously. This includes: pre-study evaluation for compliance (fasting,&#xD;
      dinner consumption, limited polyphenol intake) and readiness for study visit, catheter&#xD;
      placement by registered nurse, fasting blood sample, consumption of high fat/carbohydrate&#xD;
      meal accompanied by 1 of the two treatment beverages (active/fruit polyphenol or placebo&#xD;
      beverage), subsequent blood sampling from catheter [ ~1 tablespoon (12ml)] at designated time&#xD;
      points for 6 hours. Each postprandial study visit day will last approximately 7 hours and&#xD;
      subjects will be required to remain at the Clinical Nutrition Research Center at the Illinois&#xD;
      Institute of Technology main campus for the duration of the visit. The visit procedures are&#xD;
      repeated twice ~ 1 week apart to accommodate subject testing with both beverages.&#xD;
&#xD;
      After completing both acute 6 h postprandial study visits, subjects will roll over to the&#xD;
      chronic phase of the study and receive a 2nd randomization sequence for consuming the active&#xD;
      or the placebo beverage daily for 8 weeks. Before crossing over to the alternative treatment&#xD;
      beverage for another 8 weeks, subjects will have a 4-week break (wash out). Subjects will be&#xD;
      counseled for a low polyphenolic diet throughout the study to consume the assigned beverage&#xD;
      twice per day with lunch and evening meals (except during 4-week washout).&#xD;
&#xD;
      At the end of each week 8 treatment period, subjects will come to the research center for a 6&#xD;
      h postprandial study visit day: all procedures are identical on each postprandial study test&#xD;
      visit with the exception that only the placebo beverage will be consumed with the breakfast.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2012</start_date>
  <completion_date type="Actual">June 26, 2018</completion_date>
  <primary_completion_date type="Actual">March 20, 2014</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Plasma Triglycerides Concentrations</measure>
    <time_frame>Acute Postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)</time_frame>
    <description>Changes in Plasma Triglyceride concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Plasma Lipid and Lipoprotein panels</measure>
    <time_frame>Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)</time_frame>
    <description>Changes in Lipids (panel) and lipoprotein particle size/density by nuclear magnetic resonance (NMR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in insulin concentrations</measure>
    <time_frame>Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)</time_frame>
    <description>Changes in Plasma insulin concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, Cmax and TMax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in LDL oxidation</measure>
    <time_frame>Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)</time_frame>
    <description>Changes in Plasma OxLDL concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, and Cmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in F2-isoprostane concentrations</measure>
    <time_frame>Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)</time_frame>
    <description>Changes in Plasma F2-isoprostane concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phases assessed by iAUC, total AUC, Cmax and TMax</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in plasma glucose concentrations</measure>
    <time_frame>Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h).</time_frame>
    <description>Changes in Plasma glucose concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, Cmax and TMax</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in polyphenol anthocyanin concentrations</measure>
    <time_frame>Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h).</time_frame>
    <description>Changes in Plasma polyphenol anthocyanin concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, Cmax and TMax</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Nutritional and Metabolic Disease</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Active Treatment Beverage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Strawberry powder and Blackcurrent extract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Treatment Beverage</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Beverage</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Active Treatment Beverage</intervention_name>
    <description>Strawberry and Blackcurrent extract</description>
    <arm_group_label>Active Treatment Beverage</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo Treatment Beverage</intervention_name>
    <description>without active components</description>
    <arm_group_label>Placebo Treatment Beverage</arm_group_label>
    <other_name>Placebo Comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-smoking healthy overweight or class I obesity adult men and women&#xD;
&#xD;
          -  Age 40-65yr&#xD;
&#xD;
          -  Weight stable&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Able to comply and perform the procedures requested by the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers or recent past smokers&#xD;
&#xD;
          -  Men or women with known or suspected intolerance or hypersensitivity to the study&#xD;
             materials (or closely related compounds) or any of their stated ingredients&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Fasting blood glucose concentrations &gt;125 mg/dL&#xD;
&#xD;
          -  Fasting Total Cholesterol &gt;250 mg/dL (6.47mmol/L)&#xD;
&#xD;
          -  Fasting Triglycerides &gt;250 mg/dL (2.82 mmol/L)&#xD;
&#xD;
          -  Fasting LDL cholesterol &gt;180 mg/dL (4.66 mmol/L)&#xD;
&#xD;
          -  Uncontrolled blood pressure &gt;140 mmHg/90 mmHg&#xD;
&#xD;
          -  Documented vascular disease&#xD;
&#xD;
          -  Cancer other than skin (non-melanoma) in previous 5 years&#xD;
&#xD;
          -  Lactating and/or pregnant&#xD;
&#xD;
          -  Taking medications or dietary supplements eg., antioxidant supplements, lipid lowering&#xD;
             medication, blood pressure lowering medications.&#xD;
&#xD;
          -  Recent blood donors (within 3 months)&#xD;
&#xD;
          -  Vegans&#xD;
&#xD;
          -  Substance (alcohol or drug) abuser (within the last 2 years)&#xD;
&#xD;
          -  Participated in a chronic feeding or medication clinical trial in the last 3 months.&#xD;
&#xD;
          -  Excessive coffee and tea consumers (&gt; 4 cups/d)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Britt Burton-Freeman, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Illinois Institute of Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Indika Edirisinghe, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Illinois Instutute of Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Nutrition Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>Polyphenols</keyword>
  <keyword>Berries</keyword>
  <keyword>Overweight</keyword>
  <keyword>Lipid Panels</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Chronic Disease</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/NCT01729949
org study id: PPF 2012-073
nct id: NCT01729949
lead sponsor: 
collaborator: 
has dmc: No
1. The primary objective is to determine the effect of fruit polyphenols on postprandial
           lipoprotein triglyceride metabolism after consumption a standard high carbohydrate/fat
           breakfast meal with a beverage rich in fruit-derived polyphenols compared to energy and
           macro-/micro-nutrient matched control beverage (acute, Part 1).

        2. Secondary objectives are: 1)to assess the effects of consuming daily for 8 weeks
           (chronic, Part 2) a beverage rich in fruit polyphenols compared to an energy and
           macro-/micro- nutrient matched control beverage on fasting glucose, insulin, lipids and
           markers of oxidative stress; and 2) to assess the effects of these beverages on
           meal-related changes in metabolic and oxidative stress measures after 8 weeks daily
           consumption.
The study is a single-center, double-blinded, randomized, 2-part, 2-arm, 4-sequence,
      crossover study that incorporates both the acute and chronic evaluations of fruit polyphenols
      on metabolic indices and markers of oxidative stress.

      A planned sample size of 30 overweight men and women will be recruited into the study.
      Subjects will be required to meet several inclusion and exclusion criteria, which will be
      assessed through online and clinic screening mechanisms, including questionnaires, blood
      analysis, and anthropometric measurements. Eligible subjects will be invited to participate
      in the study. Subjects will begin by completing a 7-day pre-study assessment of their usual
      dietary intake using 3-day food diary followed by washout of dietary polyphenols. Subjects
      will participate in 4, 6 h postprandial study days: 2 preceding the chronic intervention and
      2 after 8 weeks each of active (fruit polyphenols) and placebo beverages. Subjects will be
      randomized on the first day of starting the acute and chronic study phases. Subjects will be
      asked to limit polyphenolic containing foods and beverages for 3 days prior to each 6 h
      postprandial study visit as well through the chronic dietary intervention. Subjects will be
      provided a standardized dinner meal pack on the day before each 6 h postprandial visit.

      For each 6 h postprandial study visit, subjects will arrive fasted and follow procedures
      published by our lab previously. This includes: pre-study evaluation for compliance (fasting,
      dinner consumption, limited polyphenol intake) and readiness for study visit, catheter
      placement by registered nurse, fasting blood sample, consumption of high fat/carbohydrate
      meal accompanied by 1 of the two treatment beverages (active/fruit polyphenol or placebo
      beverage), subsequent blood sampling from catheter [ ~1 tablespoon (12ml)] at designated time
      points for 6 hours. Each postprandial study visit day will last approximately 7 hours and
      subjects will be required to remain at the Clinical Nutrition Research Center at the Illinois
      Institute of Technology main campus for the duration of the visit. The visit procedures are
      repeated twice ~ 1 week apart to accommodate subject testing with both beverages.

      After completing both acute 6 h postprandial study visits, subjects will roll over to the
      chronic phase of the study and receive a 2nd randomization sequence for consuming the active
      or the placebo beverage daily for 8 weeks. Before crossing over to the alternative treatment
      beverage for another 8 weeks, subjects will have a 4-week break (wash out). Subjects will be
      counseled for a low polyphenolic diet throughout the study to consume the assigned beverage
      twice per day with lunch and evening meals (except during 4-week washout).

      At the end of each week 8 treatment period, subjects will come to the research center for a 6
      h postprandial study visit day: all procedures are identical on each postprandial study test
      visit with the exception that only the placebo beverage will be consumed with the breakfast.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes in Plasma Triglycerides Concentrations
time frame: Acute Postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
description: Changes in Plasma Triglyceride concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC
measure: Changes in Plasma Lipid and Lipoprotein panels
time frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
description: Changes in Lipids (panel) and lipoprotein particle size/density by nuclear magnetic resonance (NMR)
measure: Changes in insulin concentrations
time frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
description: Changes in Plasma insulin concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, Cmax and TMax
measure: Changes in LDL oxidation
time frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
description: Changes in Plasma OxLDL concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, and Cmax
measure: Changes in F2-isoprostane concentrations
time frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h)
description: Changes in Plasma F2-isoprostane concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phases assessed by iAUC, total AUC, Cmax and TMax
measure: Changes in plasma glucose concentrations
time frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h).
description: Changes in Plasma glucose concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, Cmax and TMax
measure: Changes in polyphenol anthocyanin concentrations
time frame: Acute postprandial (6 h) and chronic (8 week) fasting and postprandial (6 h).
description: Changes in Plasma polyphenol anthocyanin concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by iAUC, total AUC, Cmax and TMax
arm group label: Active Treatment Beverage
arm group type: Active Comparator
description: Strawberry powder and Blackcurrent extract
arm group label: Placebo Treatment Beverage
arm group type: Placebo Comparator
description: Placebo Beverage
intervention type: Dietary Supplement
intervention name: Active Treatment Beverage
description: Strawberry and Blackcurrent extract
arm group label: Active Treatment Beverage
other name: Active Comparator
intervention type: Dietary Supplement
intervention name: Placebo Treatment Beverage
description: without active components
arm group label: Placebo Treatment Beverage
other name: Placebo Comparator
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Britt Burton-Freeman, Ph.D
role: Principal Investigator
affiliation: Illinois Institute of Technology
last name: Indika Edirisinghe, Ph.D
role: Study Chair
affiliation: Illinois Instutute of Technology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
mesh term: Metabolic Diseases
mesh term: Chronic Disease