<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/NCT03286608</url>
  </required_header>
  <id_info>
    <org_study_id>Three-City study Bordeaux</org_study_id>
    <nct_id>NCT03286608</nct_id>
  </id_info>
  <brief_title>Polyphenols and Risk of Dementia</brief_title>
  <official_title>Pattern of Polyphenol Intake and the Long-term Risk of Dementia in Older Persons</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jean-François Dartigues</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bordeaux</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>
      This project aims to leverage existing data from a large observational prospective study on&#xD;
      dementia, the Three-City study, to investigate the relationship between intakes of&#xD;
      polyphenols and the risk to develop dementia in the 12 years following dietary assessment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study sample includes 1,329 subjects followed for up to 12 years fro dementia after&#xD;
      dietary assessment. The aim is to identify a pattern of polyphenol intake (based on 26&#xD;
      flavonoid and non-flavonoid polyphenol subclasses ascertained using a 24-hour dietary recall)&#xD;
      associated with the risk of dementia and AD over 12 years in the 3C Bordeaux cohort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1999</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of dementia</measure>
    <time_frame>12 years</time_frame>
    <description>incident cases of dementia diagnosed by the expert committee of neurologists at follow-up visits</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of Alzheimer's disease</measure>
    <time_frame>12 years</time_frame>
    <description>dementia with probable or possible Alzheimer etiology</description>
  </secondary_outcome>
  <enrollment type="Actual">1329</enrollment>
  <condition>Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, Epidemiology</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observational study (no intervention)</intervention_name>
    <description>Statistical association between adherence to a pattern of polyphenol intake and the risk to develop dementia and Alzheimer's disease over 12 years</description>
    <other_name>pattern of polyphenol intake</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        population of older persons from the community, aged 65 years or more, living in the&#xD;
        Bordeaux area (France)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  65 years or more, live in Bordeaux area (France)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with dementia at the time of dietary assessment in year 2001-2002&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Bordeaux</investigator_affiliation>
    <investigator_full_name>Jean-François Dartigues</investigator_full_name>
    <investigator_title>Pr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03286608
org study id: Three-City study Bordeaux
nct id: NCT03286608
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project aims to leverage existing data from a large observational prospective study on
      dementia, the Three-City study, to investigate the relationship between intakes of
      polyphenols and the risk to develop dementia in the 12 years following dietary assessment.
The study sample includes 1,329 subjects followed for up to 12 years fro dementia after
      dietary assessment. The aim is to identify a pattern of polyphenol intake (based on 26
      flavonoid and non-flavonoid polyphenol subclasses ascertained using a 24-hour dietary recall)
      associated with the risk of dementia and AD over 12 years in the 3C Bordeaux cohort.
observational model: Cohort
time perspective: Prospective
measure: incidence of dementia
time frame: 12 years
description: incident cases of dementia diagnosed by the expert committee of neurologists at follow-up visits
measure: incidence of Alzheimer's disease
time frame: 12 years
description: dementia with probable or possible Alzheimer etiology
intervention type: Other
intervention name: observational study (no intervention)
description: Statistical association between adherence to a pattern of polyphenol intake and the risk to develop dementia and Alzheimer's disease over 12 years
other name: pattern of polyphenol intake
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: University of Bordeaux
investigator full name: Jean-François Dartigues
investigator title: Pr
mesh term: Alzheimer Disease
mesh term: Dementia
sharing ipd: No