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

NCT04461951 | Unknown

• 1 other identifier: NutBrain2018
• Study Type: observational
• Target: 643
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction; Dietary Habits

Keywords

Cognitive Impairments, Dietary habits, Gut Microbiota, Brain

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• 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)

Study Arms (1)

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)

Interventions

Lifestyles (exposure) OTHER

no intervention

Also known as: no intervention

Community dwelling seniors

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead
• Institute of Biomedical Technologies-National Research Council (ITB-CNR): collaborator

Study Sites (1)

Struttura Semplice Neuropsicologia Clinica/ Centro UVA

Pavia, 27100, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 38551689 DERIVED

• 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.

  PMID: 38280834 DERIVED

• 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.

  PMID: 36419980 DERIVED

• 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.

  PMID: 32703186 DERIVED

Related Links

• Official web-site of the NutBrain study project

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.

MeSH Terms

Conditions

Cognitive Dysfunction; Feeding Behavior

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior, Animal; Behavior

Study Officials

• Federica Prinelli, PhD

  IRCCS C. Mondino Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica Prinelli, PhD

CONTACT

0039 3479925657; federica.prinelli@itb.cnr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 8, 2020
• Study Start: April 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: April 1, 2022
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)