{"type":"trials","record":{"id":32237,"source_id":"clinicaltrials-gov","external_id":"NCT04461951","title":"Nutrition, gUT Microbiota, and BRain AgINg: the NutBrain Study","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.","overall_status":"Unknown","phases":[],"study_type":"OBSERVATIONAL","sponsor":"IRCCS National Neurological Institute \"C. Mondino\" Foundation","enrollment":643,"countries":["Italy"],"start_date":"2019-04-01","completion_date":"2022-04-01","last_update_date":"2020-07-08","source_url":"https://clinicaltrials.gov/study/NCT04461951","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Unknown. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:23.954312+00:00","last_seen_at":"2026-09-25T06:10:45.89+00:00","metadata":{"sex":"ALL","acronym":"NutBrain","age_range":"65 Years","comparator":null,"organization":"IRCCS National Neurological Institute \"C. Mondino\" Foundation","interventions":["Lifestyles (exposure)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of participants with Mild Cognitive Impairment (MCI) in community dwelling older adults — Screening evaluation a…","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)"],"design_description":null,"source_has_results":false},"controlled_terms":["Cognitive Dysfunction","Dietary Habits","Lifestyles (exposure)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: brain aging.","quality_checked_at":"2026-09-25T06:10:48.460085+00:00","duplicate_cluster_key":"id:nct04461951","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-04-01 to 2022-04-01","comparator":null,"confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:45.913Z","intervention":["Lifestyles (exposure)"],"participants":643,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Number of participants with Mild Cognitive Impairment (MCI) in community dwelling older adults — Screening evaluation a…","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)"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"cognitive-aging","is_published":true,"match_reasons":["Title contains controlled term: brain aging.","Abstract contains controlled term: cognitive ageing.","Title supplies longevity context: aging.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Cognitive ageing","slug":"cognitive-aging"}},{"topic_slug":"microbiome-dysbiosis","is_published":true,"match_reasons":["Title contains controlled term: gut microbiota.","Abstract contains controlled term: microbiome, gut microbiota.","Title supplies longevity context: aging.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Microbiome and dysbiosis","slug":"microbiome-dysbiosis"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/32237","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}