{"type":"trials","record":{"id":33833,"source_id":"clinicaltrials-gov","external_id":"NCT05449119","title":"Loss of Autonomy in the Elderly: Relationships Between Gut Microbiota Diversity, Nutrition and Cognitive and Sensory-motor Disturbances in \"Small Eaters\" and \"Non Small Eaters\"","brief_summary":"Older adults currently make up 25% of the population in France, and future health expenditures will be largely related to the consequences of aging. Normal aging is associated with a progressive decrease in cognitive and sensorimotor function, malnutrition and/or under-nutrition and intestinal dysbiosis (i.e. changes in the composition and/or stability of the microbiota). Furthermore, admission to long-term care facilities such as Etablissement d'Hébergement pour Personnes Agées Dépendantes (EHPAD) leads to drastic changes in lifestyle in terms of (i) nutrition and (ii) motor functions. These modifications can influence the composition of the intestinal microbiota and its temporal evolution. We will study the relationship between the deterioration of cognitive and sensorimotor function, diet and intestinal well-being (i.e. microbiota) of a cohort of older adults (\\>75 years) defined as \"small eaters\" from their admission in EHPAD at the University Hospital of Dijon. This study will be carried out by a unique French multidisciplinary consortium that includes academics and health professionals, who will be able to specify the criteria defining the \"small eaters\" and to envisage suitable dietary strategies aiming to preserve their nutritional status and intestinal well-being. The final goal is to improve quality of life at home by prolonging autonomy and independence, and thus to deferring admission to an EHPAD for as long as possible. The objective of this study is to build a cohort of elderly \"small eaters\" and a cohort of elderly \"non small eaters\". These patients will be followed over a period of one year. The evolution of the composition of the intestinal microbiota will be determined in order to establish the existing relations between the composition of digestive microbiota, the nutritional state, and cognitive and sensorimotor function.","overall_status":"Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Centre Hospitalier Universitaire Dijon","enrollment":140,"countries":["France"],"start_date":"2023-06-13","completion_date":"2028-06-01","last_update_date":"2024-08-15","source_url":"https://clinicaltrials.gov/study/NCT05449119","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:11.953004+00:00","last_seen_at":"2026-09-25T06:05:41.111+00:00","metadata":{"sex":"ALL","acronym":"ALMICO","age_range":"75 Years","comparator":null,"organization":"Centre Hospitalier Universitaire Dijon","interventions":["Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data","Body Mass Index (BMI)","24-hour food and beverage record","Mini Nutritional assessment (MNA)","Measurement of muscle mass by bioelectrical impedance analysis (except for participants with a pacemaker)","Measurement of sensorimotor functions","Measurement of cognitive functions"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Measurement of the alpha diversity of the microbiota and the intestinal mycobiota — up to T12 months","Measurement of the beta diversity of the microbiota and the intestinal mycobiota — up to T12 months"],"design_description":null,"source_has_results":false},"controlled_terms":["Elderly Small Eater","Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data","Body Mass Index (BMI)","24-hour food and beverage record","Mini Nutritional assessment (MNA)","Measurement of muscle mass by bioelectrical impedance analysis (except for participants with a pacemaker)","Measurement of sensorimotor functions","Measurement of cognitive functions"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: gut microbiota.","quality_checked_at":"2026-09-25T06:05:45.671606+00:00","duplicate_cluster_key":"id:nct05449119","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-06-13 to 2028-06-01","comparator":null,"confidence":"structured-source","population":"ALL · 75 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":"2026-09-25T06:05:41.148Z","intervention":["Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data","Body Mass Index (BMI)","24-hour food and beverage record","Mini Nutritional assessment (MNA)","Measurement of muscle mass by bioelectrical impedance analysis (except for participants with a pacemaker)","Measurement of sensorimotor functions","Measurement of cognitive functions"],"participants":140,"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":["Measurement of the alpha diversity of the microbiota and the intestinal mycobiota — up to T12 months","Measurement of the beta diversity of the microbiota and the intestinal mycobiota — up to T12 months"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"microbiome-dysbiosis","is_published":true,"match_reasons":["Title contains controlled term: gut microbiota.","Abstract contains controlled term: dysbiosis.","Title supplies longevity context: elderly.","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/33833","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}