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NutBrain
Exploring the Relationship Between Nutrition, gUT Microbiota, and BRain AgINg in Community-dwelling Seniors: the NutBrain Study
Sponsor study identifier
observational
643
1 country
1
Study Start
April 1, 2019
Actual (reported)Primary Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2019
Actual (reported)June 29, 2020
Actual (reported)July 8, 2020
Actual (reported)October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of participants with Mild Cognitive Impairment (MCI) in community dwelling older adults
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.
Screening evaluation at T=2 (24 months after T=0)
Brain MRI measures
Clinical evaluation at T=3 (32 months after T=0)
Bacterial composition of stool samples in terms of relative abundance
Clinical evaluation at T=3 (32 months after T=0)
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.
no intervention
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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.
Struttura Semplice Neuropsicologia Clinica/ Centro UVA
Pavia, 27100, Italy
Prinelli F, Mastropietro A, Bernini S, Camboni T, Consolandi C, Conti S, Costa A, Cotta Ramusino M, Jesuthasan N, Pansarasa O, Perdixi E, Pichiecchio A, Rizzo G, Scarian E, Severgnini M; NutBrain Study Working Group. Impacts of an antioxidant-rich diet and lifestyle factors on gut microbiota diversity and brain health: An exploratory analysis from the NutBrain study. Clin Nutr. 2026 Mar;58:106585. doi: 10.1016/j.clnu.2026.106585. Epub 2026 Feb 2.
Perdixi E, Cotta Ramusino M, Costa A, Bernini S, Conti S, Jesuthasan N, Severgnini M, Prinelli F; NutBrain Study Group. Polypharmacy, drug-drug interactions, anticholinergic burden and cognitive outcomes: a snapshot from a community-dwelling sample of older men and women in northern Italy. Eur J Ageing. 2024 Mar 29;21(1):11. doi: 10.1007/s10433-024-00806-0.
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.
Federica Prinelli, PhD
IRCCS C. Mondino Foundation
First Submitted
June 29, 2020
First Posted
July 8, 2020
Study Start
April 1, 2019
Actual (reported)Primary Completion
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Bernini S, Conti S, Perdixi E, Jesuthasan N, Costa A, Severgnini M, Ramusino MC, Prinelli F; NutBrain Study Group. Investigating the individual and joint effects of socioeconomic status and lifestyle factors on mild cognitive impairment in older Italians living independently in the community: results from the NutBrain study. J Nutr Health Aging. 2024 Mar;28(3):100040. doi: 10.1016/j.jnha.2024.100040. Epub 2024 Jan 26.
Perdixi E, Bernini S, Conti S, Jesuthasan N, Cotta Ramusino M, Costa A, Prinelli F. Pre-existing mental health disorders and fear of COVID-19 pandemic: Data from a phone survey in community-dwelling older adults recruited in the NutBrain study. Front Psychiatry. 2022 Nov 7;13:995308. doi: 10.3389/fpsyt.2022.995308. eCollection 2022.
Prinelli F, Jesuthasan N, Severgnini M, Musicco M, Adorni F, Correa Leite ML, Crespi C, Bernini S. Exploring the relationship between Nutrition, gUT microbiota, and BRain AgINg in community-dwelling seniors: the Italian NutBrain population-based cohort study protocol. BMC Geriatr. 2020 Jul 23;20(1):253. doi: 10.1186/s12877-020-01652-2.
Study Completion
April 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 8, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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