<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/NCT04461951</url>
  </required_header>
  <id_info>
    <org_study_id>NutBrain2018</org_study_id>
    <nct_id>NCT04461951</nct_id>
  </id_info>
  <brief_title>Nutrition, gUT Microbiota, and BRain AgINg: the NutBrain Study</brief_title>
  <acronym>NutBrain</acronym>
  <official_title>Exploring the Relationship Between Nutrition, gUT Microbiota, and BRain AgINg in Community-dwelling Seniors: the NutBrain Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS National Neurological Institute &quot;C. Mondino&quot; Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Biomedical Technologies-National Research Council (ITB-CNR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IRCCS National Neurological Institute &quot;C. Mondino&quot; Foundation</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>
      Epidemiological evidence suggests that healthy diet is associated with a slowdown of&#xD;
      cognitive decline leading to dementia, but the underlying mechanisms are still partially&#xD;
      unexplored. Diet is the main determinant of gut microbiota' composition, which in turn&#xD;
      impacts on brain structures and functions, however to date no studies on this topic are&#xD;
      available. The goal of the present paper is to describe the design and methodology of the&#xD;
      NutBrain Study aimed at investigating the association of dietary habits with cognitive&#xD;
      function, and their role in modulating the gut microbiota composition, and brain measures as&#xD;
      well.&#xD;
&#xD;
      This is a population-based cohort study of community-dwelling adults aged 65 years or more&#xD;
      living in Northern Milan, Italy. At the point of presentation people are screened for&#xD;
      cognitive functions. Socio-demographic characteristics along with lifestyles and dietary&#xD;
      habits, medical history, drugs, functional status, and anthropometric measurements are also&#xD;
      recorded. Individuals suspected to have cognitive impairment at the screening phase undergo a&#xD;
      clinical evaluation including a neurological examination and a Magnetic Resonance Imaging&#xD;
      (MRI) scanning (both structural and functional). Stool and blood samples for the gut&#xD;
      microbiota analysis and for the evaluation of putative biological markers are also collected.&#xD;
      For each subject with a confirmed diagnosis of Mild Cognitive Impairment (MCI), two&#xD;
      cognitively intact controls of the same sex and age are visited. The investigators intend to&#xD;
      enrol at least 683 individuals for the screening phase and approximately 240 persons for the&#xD;
      clinical assessment.&#xD;
&#xD;
      The NutBrain is an innovative study that incorporates modern and advanced technologies (i.e.&#xD;
      microbiome and neuroimaging) into traditional epidemiologic design. The study represents a&#xD;
      unique opportunity to address key questions about the role of modifiable risk factors on&#xD;
      cognitive impairment, with a particular focus on dietary habits and their association with&#xD;
      gut microbiota and markers of the brain-aging process. These findings will help to encourage&#xD;
      and plan lifestyle interventions, for both prevention and treatment, aiming at promoting&#xD;
      healthy cognitive ageing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The NutBrain Study aims to understand the biological mechanisms through which diet influences&#xD;
      cognitive disorders with a special focus on the impact of nutrition on gut microbiota and&#xD;
      brain characteristics, by applying a novel multi-level approach that integrates traditional&#xD;
      epidemiological methods with neuroimaging and gut microbiota profiling. Aims of the NutBrain&#xD;
      study are: i) to estimate the occurrence of MCI and other cognitive disorders in&#xD;
      community-dwelling older people aged 65 + years; ii) to investigate the association between&#xD;
      lifestyle habits and cognitive ageing outcomes; iii) to explore the role of diet, in&#xD;
      modulating the gut microbiota composition, which in turn impacts on brain structures and&#xD;
      functions as well.&#xD;
&#xD;
      The NutBrain Study is an ongoing population-based cohort study promoted by the Institute of&#xD;
      Biomedical Technologies of the National Research Council (ITB-CNR, Segrate, Italy) and the&#xD;
      Hospital IRCCS Fondazione Mondino (Pavia, Italy). The NutBrain Study is structured in three&#xD;
      phases:&#xD;
&#xD;
      T=1 Participant's recruitment. The study is performed in two sites in the outskirt of&#xD;
      North-Milan: Bollate and Baranzate. A random sample is drawn from the official register of&#xD;
      residents in the two municipalities. Inclusion criteria are: attending a medical appointment&#xD;
      in the research facility, living at home in one of the two municipalities, and being 65+&#xD;
      years. Eligible population is contacted by means of a letter of invitation, in which people&#xD;
      are invited to contact the ITB-CNR by phone to schedule the first visit during which he/she&#xD;
      is asked to bring last instrumental and clinical exams prescribed by their general&#xD;
      practitioner. A comprehensive communication campaign is implemented to publicize and promote&#xD;
      the project as well as to foster recruitment. To ensure a high enrolment rate, the Mayors of&#xD;
      the two municipalities have been actively involved since the earliest planning stages of the&#xD;
      recruitment and have granted patronage to the project. Additionally, the study is promoted&#xD;
      and advertised at the community level through different channels: by printing brochures and&#xD;
      setting posters in senior recreation centres, shops, pharmacies, medical doctors office, and&#xD;
      patients associations; by articles and advertisements in local newspapers, institution&#xD;
      websites, as well as in social media (e.g. Facebook,&#xD;
      https://www.facebook.com/TheNutBrainStudy/). The NutBrain Study has a website&#xD;
      (www.nutbrain.it) where potential participants are directed for further information and can&#xD;
      register interest to participate. In addition, to raise awareness, several public events&#xD;
      describing the objectives of the proposed study are organized for recruiting eligible people.&#xD;
&#xD;
      T=2 Screening evaluation. Participants are visited at the research facility in their&#xD;
      residence town (arranging home visits for disabled individuals) by a trained team. Informed&#xD;
      consent form is completed at the research facility prior to data collection. In those&#xD;
      individuals without capacity to give full informed consent, proxy consent is collected from&#xD;
      relatives or caregivers. This 2-hours interview includes a face-to-face administration of a&#xD;
      neuropsychological battery of tests and questionnaires to inquire about socio-demographic,&#xD;
      occupational, and social-economic data, education, medical conditions and drug use, lifestyle&#xD;
      habits, functional status, and dietary behaviours. At the end of the visit, a stool sampling&#xD;
      kit, consisting of a sterile faeces container with instructions explaining the procedure for&#xD;
      the stool sample collection, and a 3-day food diary is provided to each participant. The&#xD;
      first visit serves to screen each participant for cognitive functions and for identifying&#xD;
      inclusion/exclusion criteria in a more comprehensive manner.&#xD;
&#xD;
      T=3 Clinical evaluation. Individuals suspected to have cognitive impairment at the screening&#xD;
      neuropsychological tests undergo a clinical examination. Participants are transported from&#xD;
      their own home to the Hospital using a private transport service, whose cost is covered&#xD;
      entirely by the study. The hospital visit includes a standard neurological examination&#xD;
      performed by a neurologist and a 3T Magnetic Resonance Imaging (MRI) scanning. At this stage,&#xD;
      blood and stool samples are collected from each participant and stored in the biorepository&#xD;
      at the Hospital until processing. For each subject with a clinical diagnosis of MCI, two&#xD;
      cognitively intact controls of the same sex and of the closest date of birth are enrolled and&#xD;
      visited at the Hospital (case-control design), undergoing the same protocol as MCI&#xD;
      individuals.&#xD;
&#xD;
      Date security Data are handled, monitored, computerised, and stored in accordance with the&#xD;
      European General Data Protection Regulation (EU) 2016/679 (GDPR) (https://gdpr-info.eu/). All&#xD;
      study records, including the consent forms, are kept in a locked filing cabinet at the&#xD;
      ITB-CNR where the file server for data storage is located. The file server is firewalled&#xD;
      within the ITB-CNR intranet. For privacy and security, a password granted only to the server&#xD;
      administrator is required to access to the database. The data forms are double checked for&#xD;
      missing data and inconsistencies. Quality of the database entered data is monitored by&#xD;
      checking entry for a random sample of participants. Data transfer is protected by means of&#xD;
      crypting/decrypting policy and password protection. In the final dataset a unique key&#xD;
      identifies each subject to guarantee anonymity. Personal data are regarded as strictly&#xD;
      confidential and removed before the exportation procedure. Security of data is guarantee via&#xD;
      automatic backups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with Mild Cognitive Impairment (MCI) in community dwelling older adults</measure>
    <time_frame>Screening evaluation at T=2 (24 months after T=0)</time_frame>
    <description>Measured using a battery of well-established neuropsychological tests exploring global cognitive function (Mini Mental State Examination-MMSE) and different cognitive domains: memory (Free and Cues Selective Reminding Test (FCSRT), Logical memory test - Babcock Test, the Rey-Osterrieth Complex Figure Test (ROCF) - delay recall, executive function (Frontal Assessment Battery (FAB)), phonemic and semantic verbal fluency, Trial Making Test (TMT), language (Picture Naming Test), visuo-spatial abilities (Rey-Osterrieth Complex Figure Test (ROCF) - copy). All the test scores are corrected for age, sex, and education and compared with the values available for the Italian population. Diagnosis follows the Albert criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain MRI measures</measure>
    <time_frame>Clinical evaluation at T=3 (32 months after T=0)</time_frame>
    <description>Neuroimaging data are acquired, pre-processed and analyzed at the Hospital. MRI data are acquired using a 3 Tesla Skyra scanner (Siemens, Erlangen, Germany). MRI measures include structural (high resolution T1 anatomical scan - grey matter volume/density, cortical thickness; Diffusion Tensor Imaging scan: white matter microstructural integrity) and functional characteristics (resting state fMRI sequence: functional connectivity at rest)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacterial composition of stool samples in terms of relative abundance</measure>
    <time_frame>Clinical evaluation at T=3 (32 months after T=0)</time_frame>
    <description>Total bacterial DNA is extracted from stool samples and the V3-V4 regions of the microbial 16S rRNA gene are PCR-amplified. Alpha-diversity (i.e.: species diversity within samples) is calculated.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">643</enrollment>
  <condition>Cognitive Dysfunction</condition>
  <condition>Dietary Habits</condition>
  <arm_group>
    <arm_group_label>Community dwelling seniors</arm_group_label>
    <description>Participants are visited at the research facility in their residence town by a trained team. Informed consent form is completed at the research facility prior to data collection. In those individuals without capacity to give full informed consent, proxy consent is collected from relatives or caregivers. This 2-hours interview includes a face-to-face administration of a neuropsychological battery of tests and questionnaires to inquire about socio-demographic, occupational, and social-economic data, education, medical conditions and drug use, lifestyle habits, functional status, and dietary behaviours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lifestyles (exposure)</intervention_name>
    <description>no intervention</description>
    <arm_group_label>Community dwelling seniors</arm_group_label>
    <other_name>no intervention</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and stool samples are collected from each participant and stored in the biorepository&#xD;
      at the Hospital for gut microbiota analysis and the evaluation of putative biological&#xD;
      markers.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This is a population-based cohort study of community-dwelling adults aged 65 years or more&#xD;
        living in Northern Milan, Italy (Bollate and Baranzate municipalities). A random sample is&#xD;
        drawn from the official register of residents in the two municipalities. Eligible&#xD;
        population is contacted by means of a letter of invitation, in which people are invited to&#xD;
        contact the ITB-CNR by phone to schedule the first visit during which he/she is asked to&#xD;
        bring last instrumental and clinical exams prescribed by their general practitioner.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  attending a medical appointment in the research facility&#xD;
&#xD;
          -  living at home in one of the two municipalities&#xD;
&#xD;
          -  being 65+ years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i) neuropsychological criteria:&#xD;
&#xD;
          -  subject with dementia, pre-existing cognitive impairment (e.g. aphasia, neglect),&#xD;
             concomitant severe psychiatric disease, others neurological conditions (e.g. severe&#xD;
             depression and behavioral disorders)&#xD;
&#xD;
          -  severe sensory disturbances (e.g. auditory and/or visual loss) that do not allow&#xD;
             completing neuropsychological assessment&#xD;
&#xD;
        ii) microbiota' analysis protocol:&#xD;
&#xD;
          -  individuals with artificial nutrition in progress&#xD;
&#xD;
          -  history of active uncontrolled gastrointestinal disorders or diseases (inflammatory&#xD;
             bowel disease, ulcerative colitis, and Crohn's disease)&#xD;
&#xD;
          -  subjects who underwent previous major surgery on the gastro-enteric tract, with the&#xD;
             exception of cholecystectomy and appendectomy, in the past five years&#xD;
&#xD;
          -  use of antibiotics or large doses of commercial probiotics in the 4 weeks prior the&#xD;
             visit&#xD;
&#xD;
          -  subjects under radio-chemo-therapy&#xD;
&#xD;
        iii) MRI scanning protocol:&#xD;
&#xD;
          -  subjects with metal fragments in the body, surgically implanted devices containing&#xD;
             metal&#xD;
&#xD;
          -  severe claustrophobia&#xD;
&#xD;
          -  inability to lie down in the MRI scanner for the duration of the study&#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>
  <overall_official>
    <last_name>Federica Prinelli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS C. Mondino Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Federica Prinelli, PhD</last_name>
    <phone>0039 3479925657</phone>
    <email>federica.prinelli@itb.cnr.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Struttura Semplice Neuropsicologia Clinica/ Centro UVA</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Federica Prinelli, PhD</last_name>
      <phone>0039 3479925657</phone>
      <email>federica.prinelli@itb.cnr.it</email>
    </contact>
    <contact_backup>
      <last_name>Sara Bernini, PhD</last_name>
      <phone>0039 0382 380290</phone>
      <email>sara.bernini@mondino.it</email>
    </contact_backup>
    <investigator>
      <last_name>Federica Prinelli, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.nutbrain.it/</url>
    <description>Official web-site of the NutBrain study project</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive Impairments, Dietary habits, Gut Microbiota, Brain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT04461951
org study id: NutBrain2018
nct id: NCT04461951
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Epidemiological evidence suggests that healthy diet is associated with a slowdown of
      cognitive decline leading to dementia, but the underlying mechanisms are still partially
      unexplored. Diet is the main determinant of gut microbiota' composition, which in turn
      impacts on brain structures and functions, however to date no studies on this topic are
      available. The goal of the present paper is to describe the design and methodology of the
      NutBrain Study aimed at investigating the association of dietary habits with cognitive
      function, and their role in modulating the gut microbiota composition, and brain measures as
      well.

      This is a population-based cohort study of community-dwelling adults aged 65 years or more
      living in Northern Milan, Italy. At the point of presentation people are screened for
      cognitive functions. Socio-demographic characteristics along with lifestyles and dietary
      habits, medical history, drugs, functional status, and anthropometric measurements are also
      recorded. Individuals suspected to have cognitive impairment at the screening phase undergo a
      clinical evaluation including a neurological examination and a Magnetic Resonance Imaging
      (MRI) scanning (both structural and functional). Stool and blood samples for the gut
      microbiota analysis and for the evaluation of putative biological markers are also collected.
      For each subject with a confirmed diagnosis of Mild Cognitive Impairment (MCI), two
      cognitively intact controls of the same sex and age are visited. The investigators intend to
      enrol at least 683 individuals for the screening phase and approximately 240 persons for the
      clinical assessment.

      The NutBrain is an innovative study that incorporates modern and advanced technologies (i.e.
      microbiome and neuroimaging) into traditional epidemiologic design. The study represents a
      unique opportunity to address key questions about the role of modifiable risk factors on
      cognitive impairment, with a particular focus on dietary habits and their association with
      gut microbiota and markers of the brain-aging process. These findings will help to encourage
      and plan lifestyle interventions, for both prevention and treatment, aiming at promoting
      healthy cognitive ageing.
The NutBrain Study aims to understand the biological mechanisms through which diet influences
      cognitive disorders with a special focus on the impact of nutrition on gut microbiota and
      brain characteristics, by applying a novel multi-level approach that integrates traditional
      epidemiological methods with neuroimaging and gut microbiota profiling. Aims of the NutBrain
      study are: i) to estimate the occurrence of MCI and other cognitive disorders in
      community-dwelling older people aged 65 + years; ii) to investigate the association between
      lifestyle habits and cognitive ageing outcomes; iii) to explore the role of diet, in
      modulating the gut microbiota composition, which in turn impacts on brain structures and
      functions as well.

      The NutBrain Study is an ongoing population-based cohort study promoted by the Institute of
      Biomedical Technologies of the National Research Council (ITB-CNR, Segrate, Italy) and the
      Hospital IRCCS Fondazione Mondino (Pavia, Italy). The NutBrain Study is structured in three
      phases:

      T=1 Participant's recruitment. The study is performed in two sites in the outskirt of
      North-Milan: Bollate and Baranzate. A random sample is drawn from the official register of
      residents in the two municipalities. Inclusion criteria are: attending a medical appointment
      in the research facility, living at home in one of the two municipalities, and being 65+
      years. Eligible population is contacted by means of a letter of invitation, in which people
      are invited to contact the ITB-CNR by phone to schedule the first visit during which he/she
      is asked to bring last instrumental and clinical exams prescribed by their general
      practitioner. A comprehensive communication campaign is implemented to publicize and promote
      the project as well as to foster recruitment. To ensure a high enrolment rate, the Mayors of
      the two municipalities have been actively involved since the earliest planning stages of the
      recruitment and have granted patronage to the project. Additionally, the study is promoted
      and advertised at the community level through different channels: by printing brochures and
      setting posters in senior recreation centres, shops, pharmacies, medical doctors office, and
      patients associations; by articles and advertisements in local newspapers, institution
      websites, as well as in social media (e.g. Facebook,
      https://www.facebook.com/TheNutBrainStudy/). The NutBrain Study has a website
      (www.nutbrain.it) where potential participants are directed for further information and can
      register interest to participate. In addition, to raise awareness, several public events
      describing the objectives of the proposed study are organized for recruiting eligible people.

      T=2 Screening evaluation. Participants are visited at the research facility in their
      residence town (arranging home visits for disabled individuals) by a trained team. Informed
      consent form is completed at the research facility prior to data collection. In those
      individuals without capacity to give full informed consent, proxy consent is collected from
      relatives or caregivers. This 2-hours interview includes a face-to-face administration of a
      neuropsychological battery of tests and questionnaires to inquire about socio-demographic,
      occupational, and social-economic data, education, medical conditions and drug use, lifestyle
      habits, functional status, and dietary behaviours. At the end of the visit, a stool sampling
      kit, consisting of a sterile faeces container with instructions explaining the procedure for
      the stool sample collection, and a 3-day food diary is provided to each participant. The
      first visit serves to screen each participant for cognitive functions and for identifying
      inclusion/exclusion criteria in a more comprehensive manner.

      T=3 Clinical evaluation. Individuals suspected to have cognitive impairment at the screening
      neuropsychological tests undergo a clinical examination. Participants are transported from
      their own home to the Hospital using a private transport service, whose cost is covered
      entirely by the study. The hospital visit includes a standard neurological examination
      performed by a neurologist and a 3T Magnetic Resonance Imaging (MRI) scanning. At this stage,
      blood and stool samples are collected from each participant and stored in the biorepository
      at the Hospital until processing. For each subject with a clinical diagnosis of MCI, two
      cognitively intact controls of the same sex and of the closest date of birth are enrolled and
      visited at the Hospital (case-control design), undergoing the same protocol as MCI
      individuals.

      Date security Data are handled, monitored, computerised, and stored in accordance with the
      European General Data Protection Regulation (EU) 2016/679 (GDPR) (https://gdpr-info.eu/). All
      study records, including the consent forms, are kept in a locked filing cabinet at the
      ITB-CNR where the file server for data storage is located. The file server is firewalled
      within the ITB-CNR intranet. For privacy and security, a password granted only to the server
      administrator is required to access to the database. The data forms are double checked for
      missing data and inconsistencies. Quality of the database entered data is monitored by
      checking entry for a random sample of participants. Data transfer is protected by means of
      crypting/decrypting policy and password protection. In the final dataset a unique key
      identifies each subject to guarantee anonymity. Personal data are regarded as strictly
      confidential and removed before the exportation procedure. Security of data is guarantee via
      automatic backups.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of participants with Mild Cognitive Impairment (MCI) in community dwelling older adults
time frame: Screening evaluation at T=2 (24 months after T=0)
description: Measured using a battery of well-established neuropsychological tests exploring global cognitive function (Mini Mental State Examination-MMSE) and different cognitive domains: memory (Free and Cues Selective Reminding Test (FCSRT), Logical memory test - Babcock Test, the Rey-Osterrieth Complex Figure Test (ROCF) - delay recall, executive function (Frontal Assessment Battery (FAB)), phonemic and semantic verbal fluency, Trial Making Test (TMT), language (Picture Naming Test), visuo-spatial abilities (Rey-Osterrieth Complex Figure Test (ROCF) - copy). All the test scores are corrected for age, sex, and education and compared with the values available for the Italian population. Diagnosis follows the Albert criteria.
measure: Brain MRI measures
time frame: Clinical evaluation at T=3 (32 months after T=0)
description: Neuroimaging data are acquired, pre-processed and analyzed at the Hospital. MRI data are acquired using a 3 Tesla Skyra scanner (Siemens, Erlangen, Germany). MRI measures include structural (high resolution T1 anatomical scan - grey matter volume/density, cortical thickness; Diffusion Tensor Imaging scan: white matter microstructural integrity) and functional characteristics (resting state fMRI sequence: functional connectivity at rest)
measure: Bacterial composition of stool samples in terms of relative abundance
time frame: Clinical evaluation at T=3 (32 months after T=0)
description: Total bacterial DNA is extracted from stool samples and the V3-V4 regions of the microbial 16S rRNA gene are PCR-amplified. Alpha-diversity (i.e.: species diversity within samples) is calculated.
arm group label: Community dwelling seniors
description: Participants are visited at the research facility in their residence town by a trained team. Informed consent form is completed at the research facility prior to data collection. In those individuals without capacity to give full informed consent, proxy consent is collected from relatives or caregivers. This 2-hours interview includes a face-to-face administration of a neuropsychological battery of tests and questionnaires to inquire about socio-demographic, occupational, and social-economic data, education, medical conditions and drug use, lifestyle habits, functional status, and dietary behaviours.
intervention type: Other
intervention name: Lifestyles (exposure)
description: no intervention
arm group label: Community dwelling seniors
other name: no intervention
Blood and stool samples are collected from each participant and stored in the biorepository
      at the Hospital for gut microbiota analysis and the evaluation of putative biological
      markers.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Federica Prinelli, PhD
role: Principal Investigator
affiliation: IRCCS C. Mondino Foundation
last name: Federica Prinelli, PhD
phone: 0039 3479925657
email: federica.prinelli@itb.cnr.it
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Italy
url: http://www.nutbrain.it/
description: Official web-site of the NutBrain study project
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No