Nutrition, gUT Microbiota, and BRain AgINg: the NutBrain Study (NutBrain)
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|ClinicalTrials.gov Identifier: NCT04461951|
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
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)|
|Study Type :||Observational|
|Estimated Enrollment :||643 participants|
|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|
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)
Other Name: no intervention
- 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.
- 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)
- 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
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
|Contact: Federica Prinelli, PhD||0039 firstname.lastname@example.org|
|Struttura Semplice Neuropsicologia Clinica/ Centro UVA||Recruiting|
|Pavia, Italy, 27100|
|Contact: Federica Prinelli, PhD 0039 3479925657 email@example.com|
|Contact: Sara Bernini, PhD 0039 0382 380290 firstname.lastname@example.org|
|Principal Investigator: Federica Prinelli, PhD|
|Principal Investigator:||Federica Prinelli, PhD||IRCCS C. Mondino Foundation|