Status:
UNKNOWN
Nutrition, gUT Microbiota, and BRain AgINg: the NutBrain Study
Lead Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborating Sponsors:
Institute of Biomedical Technologies-National Research Council (ITB-CNR)
Conditions:
Cognitive Dysfunction
Dietary Habits
Eligibility:
All Genders
65+ years
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 ma...
Detailed Description
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 characteri...
Eligibility Criteria
Inclusion
- attending a medical appointment in the research facility
- living at home in one of the two municipalities
- being 65+ years
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT04461951
Start Date
April 1 2019
End Date
April 1 2022
Last Update
July 8 2020
Active Locations (1)
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1
Struttura Semplice Neuropsicologia Clinica/ Centro UVA
Pavia, Italy, 27100