- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03286608
Polyphenols and Risk of Dementia
September 14, 2017 updated by: Jean-François Dartigues
Pattern of Polyphenol Intake and the Long-term Risk of Dementia in Older Persons
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
1329
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
population of older persons from the community, aged 65 years or more, living in the Bordeaux area (France)
Description
Inclusion Criteria:
- 65 years or more, live in Bordeaux area (France)
Exclusion Criteria:
- with dementia at the time of dietary assessment in year 2001-2002
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of dementia
Time Frame: 12 years
|
incident cases of dementia diagnosed by the expert committee of neurologists at follow-up visits
|
12 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of Alzheimer's disease
Time Frame: 12 years
|
dementia with probable or possible Alzheimer etiology
|
12 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 1999
Primary Completion (Actual)
December 31, 2015
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
September 14, 2017
First Submitted That Met QC Criteria
September 14, 2017
First Posted (Actual)
September 18, 2017
Study Record Updates
Last Update Posted (Actual)
September 18, 2017
Last Update Submitted That Met QC Criteria
September 14, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Three-City study Bordeaux
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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