Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, EpidemiologyNCT03286608
Polyphenols and Risk of Dementia
An observational study of Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, Epidemiology, run by Jean-François Dartigues.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, Epidemiology
- How many people
- 1,329 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1999to 31 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: population of older persons from the community, aged 65 years or more, living in the Bordeaux area (France)
Who may be able to join
- 65 years or more, live in Bordeaux area (France)
Who cannot join
- with dementia at the time of dietary assessment in year 2001-2002
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, Epidemiology
- Being tested
- observational study (no intervention)
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational study (no intervention)Other
Also called pattern of polyphenol intake
Statistical association between adherence to a pattern of polyphenol intake and the risk to develop dementia and Alzheimer's disease over 12 years
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of dementia
incident cases of dementia diagnosed by the expert committee of neurologists at follow-up visits
Measured: 12 years
Secondary outcomes (1)
incidence of Alzheimer's disease
dementia with probable or possible Alzheimer etiology
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Jan 1999
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, EpidemiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean-François Dartigues
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean-François Dartigues, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286608
- Sponsor's protocol ID
- Three-City study Bordeaux
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Polyphenol Intake and the Long-term Risk of Dementia in Older Persons
- ClinicalTrials.gov ID
- NCT03286608
- Acronym / sponsor ID
- Three-City study Bordeaux
- Conditions
- Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,329 participants (actual)
- Lead sponsor
- Jean-François DartiguesUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- population of older persons from the community, aged 65 years or more, living in the Bordeaux area (France)
Key inclusion criteria (1 listed)
- 65 years or more, live in Bordeaux area (France)
Key exclusion criteria (1 listed)
- with dementia at the time of dietary assessment in year 2001-2002
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational study (no intervention)Also: pattern of polyphenol intakeStatistical association between adherence to a pattern of polyphenol intake and the risk to develop dementia and Alzheimer's disease over 12 years | Other | – |
Primary outcome
incidence of dementia
Time frame: 12 years
incident cases of dementia diagnosed by the expert committee of neurologists at follow-up visits
1 secondary outcome
incidence of Alzheimer's disease
Time frame: 12 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, Epidemiology, run by Jean-François Dartigues.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of dementia (time frame: 12 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.