BrainB-cubeNCT05322343
Biobank and Brain Health in Bordeaux.
An observational study of Brain and Aging, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to… Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain, Aging, Cognitive Aging
- What is being tested?
- Questionnaires, Fasting blood sampling. and Saliva collection and nasal or nasopharyngeal swab
- Type of treatment
- Injection or infusion
- How many people
- 2,050 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2022to 22 Mar 2030
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The general population from the age of 55.
Who may be able to join
- For the main study:
- live in Bordeaux metropolitan area,
- be between 55 and 80 years old (included),
- selected in terms of socioeconomic level, according to a sampling strategy by age groups and income categories representative of the general population between 55 and 80 years of age
- be affiliated with the social security system,
- agree to take a blood sample for the biobank.
- For the MRI sub-study: be between 55 and 75 years old (included). Inclusion criteria for the immune response substudy: be 70 years of age or older or participate in the MRI study; agree to take a supplemental blood sample for this substudy.
Who cannot join
- For the main study: persons under guardianship (or more generally under protection), unable to give consent to participate.
- For the MRI sub-study: have a contraindication to MRI examination (pacemaker, a valve prosthesis or any other internal electrical/magnetic device; history of neurosurgery or aneurysm; claustrophobia; presence of metal fragments in the eyes, brain or spinal cord).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Bordeaux
Bordeaux, Bordeaux, 33300
SAMIERI Cécilia, Dr, 05 57 57 45 15 ext. +33, cecilia.samieri@u-bordeaux.fr
About this study
Official title: Biobank and Brain Health in Bordeaux. A Population-based Cohort to Study the Biology of Brain and Cognitive Aging in Young Seniors
B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to prevention messages). Special interest will be given to nutrition, a promising environmental exposure for prevention.
Read the detailed description
Cognitive aging and associated pathologies, primarily dementia and its main cause Alzheimer's disease, are a major public health issue. Because of the under-diagnosis of dementia in the population and the very long preclinical phase of these diseases, population-based cohorts are essential to better understand brain aging. With the PAQUID and 3-Cités cohorts, the Bordeaux Population Health Research Center (BPH) has been a world pioneer in population-based studies on aging and dementia, and has thus contributed greatly to a better understanding of age-realted brain diseases. As these cohorts are aging, and in view of the importance of studying the early stages of brain aging, it seems essential to continue our research efforts for the prevention of cognitive aging with the establishment of a new cohort of young seniors. In addition to the population-based design of the study, the representativeness of the cohort appears to be a crucial issue (since population-based cohorts depend on the voluntary participation of healthy individuals, unfavorable exposures and altered health states are often largely under-represented, which reduces the variability of exposures and events, leading to an underestimation of prevalences, a decrease in statistical power and a potential bias in the estimation of associations). Finally, the multifactorial nature of brain ageing pathologies now calls for the replacement of the reductionist approach of risk factors by a more holistic vision of the exposome (defined as all the environmental exposures with which an individual is confronted throughout the lifecourse). The development of an integrated approach of complex, high-dimensional, multi-omics biological data (genomics, transcriptomics, epigenomics, metabolomics, proteomics), applied to various biological matrices, is an indispensable tool to deep phenotyping and to the establishment of a new generation etiological epidemiological research framework in the field of brain aging pathologies.
The Biobank and Brain health in Bordeaux cohort (B cube) will include the completion of a general questionnaire (during the V1 visit), a dietary survey (during the V1, V4 and V5 visits), a computerized cognitive battery (during the V1 visit), a collection of biological material (blood, urine, stool, saliva, hair, nails and nasopharyngeal swab) for the constitution of a biobank (during the V2 biobank visit, 2000 samples of blood, urine, hair, nails and 1000 samples expected for the other fluids/samples) An MRI will be performed in volunteers aged 55 to 70 years (during the V3 visit). Finally, a complementary visit by a medical specialist may be proposed to participants with cognitive disorders or Parkinson's syndrome.
Approximately three years after V1, a follow-up phase is proposed to the participant, comprising a block of 6 visits: a general questionnaire accompanied by a computerized cognitive battery (V7), a dietary survey (V7, V9, V10 and V11), a new collection of biological material (V8) including blood samples and hair (for all participants in the follow-up phase) and stool samples (if sampling had not taken place during V2 and for a subsample of participants at follow-up).
- Conditions
- Brain, Aging, Cognitive Aging, Immunosenescence, Mental Processes, Mental Disorders
- Being tested
- Questionnaires, Fasting blood sampling., Saliva collection and nasal or nasopharyngeal swab, Urine and stool samples, Hair and a tonenail (or hand nail) sampling
- Keywords
- Epidemiologic Methods, Risk factors, Public Health, Environmental Exposure, Exposome, Dietary Exposure, Diet, Food and Nutrition, Nutritional Status, Metabolomics, Systems biology, Environmental Biomarkers, Inflammation Mediators
- Medical subject headings
- Mental Disorders, Neurocognitive Disorders, Brain Diseases, Dementia, Alzheimer Disease, Psychological Well-Being, Behavioral Symptoms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Participants will complete a series of three questionnaires at the V1 (at home, by a trained interviewer) repeated at V7 for the follow up phase:
- A general questionnaire, with collection of general health history and exposure data
- A nutritional survey (24-hour recall), that will be repeated by telephone twice at 3-month intervals, at the V4 and V5, V6 visits. and V7, V9, V10 et V11 for the follow-up phase
- An evaluation of cognitive performance using a validated computerized battery (Cantab®), completed of neuropsychological tests to evaluate dementia syndromes, depressive symptoms and anxiety.
Fasting blood sampling.Other
In the morning, during the V2 visit by a nurse at the participant's home. Blood collection will include 8 blood tubes (volume approx.. 35.5 mL), plus 2 additional tubes for 500 participants accepting MRI, for a total volume of blood drawn of 41.5 mL for these participants. For the immunological substudy, a second sample will be taken at a distance (after 4 weeks) for 150 volunteer participants meeting the criteria.
The blood collection is repeated at V8 during the follow-up phase (21 mL).
Saliva collection and nasal or nasopharyngeal swabOther
On the day of the V2 visit, the nurse will collect a volume of saliva that has flowed spontaneously for 5 min in a sterile 40-mL polypropylene tube, and a nasal or nasopharyngeal swab using a specific kit.
Urine and stool samplesOther
During the V2 visit, the nurse will collect urine and stool samples collected by the participant in the week preceding the appointment, using the equipment provided and kept in the refrigerator. Stool sampling os repeated at V8 during the follow-up phase.
Hair and a tonenail (or hand nail) samplingOther
During the V2 visit, the nurse will collect some hair and a toenail sample from the participant, in a dedicated envelope. The hair collection is repeated at V8 during the follow-up phase.
Nasal microbiotaOther
Nasal or nasopharyngeal swab
MeasurementsOther
In addition to the samples, anthropometric measurements (weight, height,ead, waist, hip, calf and arm circumferences, subjective evaluation of body shape trajectories over the lifecourse), blood pressure, orthostatic hypotension, walking speed, grip strength, and hearing screening of sarcopenia and Parkinson's syndromes will also be collected by the nurse on the day of the V2 visit. Some of these measures (blood pressure, grip strength, screening of sarcopenia and Parkinson's syndromes) are repeated at V8 during the follow-up visit.
Analyses may be performed on the biobank samples. These analyses will include metabolite assays (Metabolon®), and may include genotyping for research purposes (without searching for specific genes.
NeuroimagingOther
A multi-sequence MRI will be performed at the V3 visit. None of the sequences used will require contrast injection. The MRI sequences used will be: a 3D MPRAGE T1-weighted sequence, a T2-weighted sequence (FLAIR), a diffusion EPI sequence, a magnetization transfer sequence, and a resting state functional MRI BOLD sequence. The total duration of the MRI examination will be approximately 50 minutes.
The MRI will be performed at the Bioimaging Institute on an imager dedicated to research activities (3T Prisma Siemens).During V3 visit, a measurement of skin autofluorescence of advanced glycation products will also be performed
Medical visitOther
For the participants with cognitive disorders (evaluated by the neuropsychologist during the V1 visit) or Parkinson's syndrome (evaluated by the nurse during the V2 visit),a complementary visit by a neurologist may be proposed in order to specify the etiology of these disorders and to establish a possible diagnosis and etiology.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | The general population from the age of 55. Receives: Other: Questionnaires; Other: Fasting blood sampling.; Other: Saliva collection and nasal or nasopharyngeal swab; Other: Urine and stool samples; Other: Hair and a tonenail (or hand nail) sampling; Other: Nasal microbiota; Other: Measurements; Other: Neuroimaging; Other: Medical visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
General questionnaire and a computerized cognitive battery.
Measured: Inclusion visit
Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
Collection of biological material for the constitution of a biobank
Measured: week 1
Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
An MRI will be performed in volunteers aged 55 to 70 years.
Measured: week 2
Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
Dietary survey
Measured: week 12 and week 24
Secondary outcomes (17)
Biobank inventory
of the following biological samples
Measured: Week 1
Cognitive performance, assessed through: non-verbal cognition-Neuropsychological
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Cognitive performance, assessed through: non-verbal cognition - Verbal fluency
Isaacs' set test (IST)
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Cognitive performance, assessed through: non-verbal cognition -Dementia
Clinical Dementia Rating scale-Sum of Boxes (CDR-SOB)
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Cognitive performance, assessed through: non-verbal cognition- Mental
Mini Mental State Examination (MMSE)
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Assement anxiety and depressive symptomatology - Anxiety
Spielberger State-Trait Anxiety Inventory (STAI)
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Assement anxiety and depressive symptomatology - Drepression
Center for Epidemiological Studies-Drepression scale (CES-D).
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Nutrition and Lifestyle evaluated
at the V4 (4 months after inclusion),V5 (8 mounths after inclusion) and V6 (12 months after inclusion) visits; and V7 (3 years after inclusion), V9 (4 months after v7), V10(8 months after v7) et V11(12 months after v7) for the follow-up phase
Measured: week 12 and week 24
Study to the microbiota intestinal, nasal and salivary
Heterogeneity and diversity.
Measured: Week 1 and V8 (1 month after v7 (3 years after inclusion))
Immunosenescence mechanism study
Identification of mechanisms immunosenescence
Measured: Week 1
Cognitive performance, assessed through: non-verbal cognition- Mental
episodic memory: Free and Cued Selective Reminding test (FCSRT) (Grober \& Buschke test in French)
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Cognitive performance, assessed through: non-verbal cognition- Mental
Executive functions: Trail Making tests A and B (TMTA and B)
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Incapacity and dependance
Estriction to mobility (Rosow and Breslow)
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Incapacity and dependance
Instrumental and basic activities of Daily Living (Lawton, Katz)
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Incapacity and dependance
Degree of dependency according to french health insurance system (AG.G.I.R)
Measured: Inclusion visit and V7 (3 years after inclusion visite)
Nutrition and Lifestyle evaluated
Physical activity (International Physical Activity Questionnaire)
Measured: at the V4 (4 months after inclusion),V5 (8 mounths after inclusion) and V6 (12 months after inclusion) visits; and V7 (3 years after inclusion), V9 (4 months after v7), V10(8 months after v7) et V11(12 months after v7) for the follow-up phase
Nutrition and Lifestyle evaluated
other lifestyle factors (smoking and alcohol intakes)
Measured: at the V4 (4 months after inclusion),V5 (8 mounths after inclusion) and V6 (12 months after inclusion) visits; and V7 (3 years after inclusion), V9 (4 months after v7), V10(8 months after v7) et V11(12 months after v7) for the follow-up phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start22 Mar 2022
- Primary completion22 Mar 2030 (estimated)
- Study completion22 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BrainStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- 2,050 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécilia SAMIERI, Dr, Principal investigator, Bordeaux Population Health Researh Center Inserm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322343
- Sponsor's protocol ID
- CHUBX 2020/34
- Acronym
- B-cube
- Status last verified
- Aug 2025
- First submitted
- 10 Mar 2022
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobank and Brain Health in Bordeaux. A Population-based Cohort to Study the Biology of Brain and Cognitive Aging in Young Seniors
- ClinicalTrials.gov ID
- NCT05322343
- Acronym / sponsor ID
- B-cube / CHUBX 2020/34
- Conditions
- Brain, Aging, Cognitive Aging, Immunosenescence, Mental Processes, Mental Disorders
- Keywords
- Epidemiologic Methods, Risk factors, Public Health, Environmental Exposure, Exposome, Dietary Exposure, Diet, Food and Nutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,050 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 22 Mar 2030 (estimated)
- Study completion
- 22 Mar 2030 (estimated)
- First posted
- 11 Apr 2022 (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.
B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to prevention messages). Special interest will be given to nutrition, a promising environmental exposure for prevention.
Detailed description
Cognitive aging and associated pathologies, primarily dementia and its main cause Alzheimer's disease, are a major public health issue. Because of the under-diagnosis of dementia in the population and the very long preclinical phase of these diseases, population-based cohorts are essential to better understand brain aging. With the PAQUID and 3-Cités cohorts, the Bordeaux Population Health Research Center (BPH) has been a world pioneer in population-based studies on aging and dementia, and has thus contributed greatly to a better understanding of age-realted brain diseases. As these cohorts are aging, and in view of the importance of studying the early stages of brain aging, it seems essential to continue our research efforts for the prevention of cognitive aging with the establishment of a new cohort of young seniors. In addition to the population-based design of the study, the representativeness of the cohort appears to be a crucial issue (since population-based cohorts depend on the voluntary participation of healthy individuals, unfavorable exposures and altered health states are often largely under-represented, which reduces the variability of exposures and events, leading to an underestimation of prevalences, a decrease in statistical power and a potential bias in the estimation of associations). Finally, the multifactorial nature of brain ageing pathologies now calls for the replacement of the reductionist approach of risk factors by a more holistic vision of the exposome (defined as all the environmental exposures with which an individual is confronted throughout the lifecourse). The development of an integrated approach of complex, high-dimensional, multi-omics biological data (genomics, transcriptomics, epigenomics, metabolomics, proteomics), applied to various biological matrices, is an indispensable tool to deep phenotyping and to the establishment of a new generation etiological epidemiological research framework in the field of brain aging pathologies.
The Biobank and Brain health in Bordeaux cohort (B cube) will include the completion of a general questionnaire (during the V1 visit), a dietary survey (during the V1, V4 and V5 visits), a computerized cognitive battery (during the V1 visit), a collection of biological material (blood, urine, stool, saliva, hair, nails and nasopharyngeal swab) for the constitution of a biobank (during the V2 biobank visit, 2000 samples of blood, urine, hair, nails and 1000 samples expected for the other fluids/samples) An MRI will be performed in volunteers aged 55 to 70 years (during the V3 visit). Finally, a complementary visit by a medical specialist may be proposed to participants with cognitive disorders or Parkinson's syndrome.
Approximately three years after V1, a follow-up phase is proposed to the participant, comprising a block of 6 visits: a general questionnaire accompanied by a computerized cognitive battery (V7), a dietary survey (V7, V9, V10 and V11), a new collection of biological material (V8) including blood samples and hair (for all participants in the follow-up phase) and stool samples (if sampling had not taken place during V2 and for a subsample of participants at follow-up).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Other: Questionnaires, Other: Fasting blood sampling., Other: Saliva collection and nasal or nasopharyngeal swab, Other: Urine and stool samples, Other: Hair and a tonenail (or hand nail) sampling, Other: Nasal microbiota, Other: Measurements, Other: Neuroimaging, Other: Medical visitThe general population from the age of 55. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The general population from the age of 55.
Key inclusion criteria (7 listed)
- live in Bordeaux metropolitan area,
- be between 55 and 80 years old (included),
- selected in terms of socioeconomic level, according to a sampling strategy by age groups and income categories representative of the general population between 55 and 80 years of age
- be affiliated with the social security system,
- agree to take a blood sample for the biobank.
Key exclusion criteria (2 listed)
- For the main study: persons under guardianship (or more generally under protection), unable to give consent to participate.
- For the MRI sub-study: have a contraindication to MRI examination (pacemaker, a valve prosthesis or any other internal electrical/magnetic device; history of neurosurgery or aneurysm; claustrophobia; presence of metal fragments in the eyes, brain or spinal cord).
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 |
|---|---|---|
| QuestionnairesParticipants will complete a series of three questionnaires at the V1 (at home, by a trained interviewer) repeated at V7 for the follow up phase: 1. A general questionnaire, with collection of general health history and exposure data 2. A nutritional survey (24-hour recall), that will be repeated by telephone twice at 3-month intervals, at the V4 and V5, V6 visits. and V7, V9, V10 et V11 for the follow-up phase 3. An evaluation of cognitive performance using a validated computerized battery (Cantab®), completed of neuropsychological tests to evaluate dementia syndromes, depressive symptoms and anxiety. | Other | Prospective cohort |
| Fasting blood sampling.In the morning, during the V2 visit by a nurse at the participant's home. Blood collection will include 8 blood tubes (volume approx.. 35.5 mL), plus 2 additional tubes for 500 participants accepting MRI, for a total volume of blood drawn of 41.5 mL for these participants. For the immunological substudy, a second sample will be taken at a distance (after 4 weeks) for 150 volunteer participants meeting the criteria. The blood collection is repeated at V8 during the follow-up phase (21 mL). | Other | Prospective cohort |
| Saliva collection and nasal or nasopharyngeal swabOn the day of the V2 visit, the nurse will collect a volume of saliva that has flowed spontaneously for 5 min in a sterile 40-mL polypropylene tube, and a nasal or nasopharyngeal swab using a specific kit. | Other | Prospective cohort |
| Urine and stool samplesDuring the V2 visit, the nurse will collect urine and stool samples collected by the participant in the week preceding the appointment, using the equipment provided and kept in the refrigerator. Stool sampling os repeated at V8 during the follow-up phase. | Other | Prospective cohort |
| Hair and a tonenail (or hand nail) samplingDuring the V2 visit, the nurse will collect some hair and a toenail sample from the participant, in a dedicated envelope. The hair collection is repeated at V8 during the follow-up phase. | Other | Prospective cohort |
| Nasal microbiotaNasal or nasopharyngeal swab | Other | Prospective cohort |
| MeasurementsIn addition to the samples, anthropometric measurements (weight, height,ead, waist, hip, calf and arm circumferences, subjective evaluation of body shape trajectories over the lifecourse), blood pressure, orthostatic hypotension, walking speed, grip strength, and hearing screening of sarcopenia and Parkinson's syndromes will also be collected by the nurse on the day of the V2 visit. Some of these measures (blood pressure, grip strength, screening of sarcopenia and Parkinson's syndromes) are repeated at V8 during the follow-up visit. Analyses may be performed on the biobank samples. These analyses will include metabolite assays (Metabolon®), and may include genotyping for research purposes (without searching for specific genes. | Other | Prospective cohort |
| NeuroimagingA multi-sequence MRI will be performed at the V3 visit. None of the sequences used will require contrast injection. The MRI sequences used will be: a 3D MPRAGE T1-weighted sequence, a T2-weighted sequence (FLAIR), a diffusion EPI sequence, a magnetization transfer sequence, and a resting state functional MRI BOLD sequence. The total duration of the MRI examination will be approximately 50 minutes. The MRI will be performed at the Bioimaging Institute on an imager dedicated to research activities (3T Prisma Siemens).During V3 visit, a measurement of skin autofluorescence of advanced glycation products will also be performed | Other | Prospective cohort |
| Medical visitFor the participants with cognitive disorders (evaluated by the neuropsychologist during the V1 visit) or Parkinson's syndrome (evaluated by the nurse during the V2 visit),a complementary visit by a neurologist may be proposed in order to specify the etiology of these disorders and to establish a possible diagnosis and etiology. | Other | Prospective cohort |
Primary outcome
Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
Time frame: Inclusion visit
General questionnaire and a computerized cognitive battery.
Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
Time frame: week 1
Collection of biological material for the constitution of a biobank
Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
Time frame: week 2
An MRI will be performed in volunteers aged 55 to 70 years.
Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed.
Time frame: week 12 and week 24
Dietary survey
17 secondary outcomes
Biobank inventory
Time frame: Week 1
Cognitive performance, assessed through: non-verbal cognition-Neuropsychological
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Cognitive performance, assessed through: non-verbal cognition - Verbal fluency
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Cognitive performance, assessed through: non-verbal cognition -Dementia
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Cognitive performance, assessed through: non-verbal cognition- Mental
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Assement anxiety and depressive symptomatology - Anxiety
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Assement anxiety and depressive symptomatology - Drepression
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Nutrition and Lifestyle evaluated
Time frame: week 12 and week 24
Study to the microbiota intestinal, nasal and salivary
Time frame: Week 1 and V8 (1 month after v7 (3 years after inclusion))
Immunosenescence mechanism study
Time frame: Week 1
Cognitive performance, assessed through: non-verbal cognition- Mental
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Cognitive performance, assessed through: non-verbal cognition- Mental
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Incapacity and dependance
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Incapacity and dependance
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Incapacity and dependance
Time frame: Inclusion visit and V7 (3 years after inclusion visite)
Nutrition and Lifestyle evaluated
Time frame: at the V4 (4 months after inclusion),V5 (8 mounths after inclusion) and V6 (12 months after inclusion) visits; and V7 (3 years after inclusion), V9 (4 months after v7), V10(8 months after v7) et V11(12 months after v7) for the follow-up phase
Nutrition and Lifestyle evaluated
Time frame: at the V4 (4 months after inclusion),V5 (8 mounths after inclusion) and V6 (12 months after inclusion) visits; and V7 (3 years after inclusion), V9 (4 months after v7), V10(8 months after v7) et V11(12 months after v7) for the follow-up phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Cécilia SAMIERI, Dr principal investigator
Bordeaux Population Health Researh Center Inserm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Aging, run by University Hospital, Bordeaux at 1 site in France.
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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cécilia SAMIERI, Dr (5 57 57 45 15 ext. +33, cecilia.samieri@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants for whom samples are available in the biobank and nutritional and cognitive surveys have been completed. (time frame: Inclusion visit). The study lists 4 primary outcomes in all. 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 11 Aug 2025.