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Nutrition, gUT Microbiota, and BRain AgINg: the NutBrain Study (NutBrain)

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ClinicalTrials.gov Identifier: NCT04461951
Recruitment Status : Unknown
Verified July 2020 by IRCCS National Neurological Institute "C. Mondino" Foundation.
Recruitment status was:  Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Institute of Biomedical Technologies-National Research Council (ITB-CNR)
Information provided by (Responsible Party):
IRCCS National Neurological Institute "C. Mondino" Foundation

Brief Summary:

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.

Condition or disease Intervention/treatment
Cognitive Dysfunction Dietary Habits Other: Lifestyles (exposure)

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Study Type : Observational
Estimated Enrollment : 643 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exploring the Relationship Between Nutrition, gUT Microbiota, and BRain AgINg in Community-dwelling Seniors: the NutBrain Study
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Community dwelling seniors
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.
Other: Lifestyles (exposure)
no intervention
Other Name: no intervention

Primary Outcome Measures :
  1. 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) ]
    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.

Secondary Outcome Measures :
  1. Brain MRI measures [ Time Frame: Clinical evaluation at T=3 (32 months after T=0) ]
    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)

  2. Bacterial composition of stool samples in terms of relative abundance [ Time Frame: Clinical evaluation at T=3 (32 months after T=0) ]
    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.

Biospecimen Retention:   Samples With DNA
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This is a population-based cohort study of community-dwelling adults aged 65 years or more living in Northern Milan, Italy (Bollate and Baranzate municipalities). A random sample is drawn from the official register of residents in the two municipalities. 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.

Inclusion Criteria:

  • attending a medical appointment in the research facility
  • living at home in one of the two municipalities
  • being 65+ years

Exclusion Criteria:

i) neuropsychological criteria:

  • subject with dementia, pre-existing cognitive impairment (e.g. aphasia, neglect), concomitant severe psychiatric disease, others neurological conditions (e.g. severe depression and behavioral disorders)
  • severe sensory disturbances (e.g. auditory and/or visual loss) that do not allow completing neuropsychological assessment

ii) microbiota' analysis protocol:

  • individuals with artificial nutrition in progress
  • history of active uncontrolled gastrointestinal disorders or diseases (inflammatory bowel disease, ulcerative colitis, and Crohn's disease)
  • subjects who underwent previous major surgery on the gastro-enteric tract, with the exception of cholecystectomy and appendectomy, in the past five years
  • use of antibiotics or large doses of commercial probiotics in the 4 weeks prior the visit
  • subjects under radio-chemo-therapy

iii) MRI scanning protocol:

  • subjects with metal fragments in the body, surgically implanted devices containing metal
  • severe claustrophobia
  • inability to lie down in the MRI scanner for the duration of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461951

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Contact: Federica Prinelli, PhD 0039 3479925657 federica.prinelli@itb.cnr.it

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Struttura Semplice Neuropsicologia Clinica/ Centro UVA Recruiting
Pavia, Italy, 27100
Contact: Federica Prinelli, PhD    0039 3479925657    federica.prinelli@itb.cnr.it   
Contact: Sara Bernini, PhD    0039 0382 380290    sara.bernini@mondino.it   
Principal Investigator: Federica Prinelli, PhD         
Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Institute of Biomedical Technologies-National Research Council (ITB-CNR)
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Principal Investigator: Federica Prinelli, PhD IRCCS C. Mondino Foundation
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IRCCS National Neurological Institute "C. Mondino" Foundation
ClinicalTrials.gov Identifier: NCT04461951    
Other Study ID Numbers: NutBrain2018
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS National Neurological Institute "C. Mondino" Foundation:
Cognitive Impairments, Dietary habits, Gut Microbiota, Brain
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders