Polyphenols and Risk of Dementia | NCT03286608

Studies
Polyphenols and Risk of Dementia

NCT03286608

Sponsor

Jean-François Dartigues

Status

Completed

Last Update Posted

Sep 18, 2017Actual

Enrollment

1,329Actual

Phase

Not provided

Conditions

Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, Epidemiology

Interventions

observational study (no intervention)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1999Actual

Primary Completion Date

Dec 31, 2015Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Sep 14, 2017

First Submission Date that Met QC Criteria

Sep 14, 2017

First Posted Date

Sep 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2017

Last Update Posted Date

Sep 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,329Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational study (no intervention)	Other	Statistical association between adherence to a pattern of polyphenol intake and the risk to develop dementia and Alzheimer's disease over 12 years		pattern of polyphenol intake

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of dementia	incident cases of dementia diagnosed by the expert committee of neurologists at follow-up visits	12 years

Secondary Outcomes

Measure	Description	Time Frame
incidence of Alzheimer's disease	dementia with probable or possible Alzheimer etiology	12 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

population of older persons from the community, aged 65 years or more, living in the Bordeaux area (France)

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided