{"type":"trials","record":{"id":15968,"source_id":"clinicaltrials-gov","external_id":"NCT07829484","title":"VIVI-OLIVE: Multicomponent Exercise and Extra Virgin Olive Oil in Older Adults at High Risk of Falls","brief_summary":"VIVI-OLIVE is a multicenter randomized clinical trial evaluating whether a 24-month intervention combining an individualized multicomponent exercise program (VIVIFRAIL), Mediterranean diet counselling, and supplementation with 60 mL/day of extra virgin olive oil (EVOO) can improve physical function and reduce fall risk in adults aged 75 years or older at high risk of falls. Participants will be randomly assigned to either the VIVI-OLIVE intervention or a control group following the VIVIFRAIL multicomponent exercise program. The main outcome is change in usual gait speed, which is an indicator of physical function and fall risk in older adults. Other outcomes include intrinsic capacity, functional independence, quality of life, muscle strength and sarcopenia, muscle characteristics, fear of falling, Mediterranean diet adherence, falls and fall-related consequences, and adherence to the study interventions.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Fundacion Miguel Servet","enrollment":140,"countries":["Spain"],"start_date":"2026-06-10","completion_date":"2029-06-01","last_update_date":"2026-09-21","source_url":"https://clinicaltrials.gov/study/NCT07829484","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":"2026-09-21T12:17:13.542458+00:00","last_seen_at":"2026-09-25T06:25:45.678+00:00","metadata":{"sex":"ALL","acronym":"VIVI-OLIVE","age_range":"75 Years","comparator":"VIVIFRAIL","organization":"Fundacion Miguel Servet","interventions":["VIVIFRAIL multicomponent exercise program","Mediterranean diet counselling","Extra virgin olive oil supplementation"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in usual gait speed — Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.","Change in physical performance assessed by the Short Physical Performance Battery (SPPB) — Baseline, 6 weeks, 3 months,…","Change in functional independence assessed by the Barthel Index — Baseline, 3 months, 6 months, 12 months, 18 months, a…","Change in health-related quality of life assessed by the EuroQol-5D — Baseline, 6 months, 12 months, 18 months, and 24…","Change in handgrip strength — From baseline to 24 months, according to the study assessment schedule.","Change in sarcopenia status — From baseline to 24 months, according to the study assessment schedule.","Change in muscle thickness assessed by musculoskeletal ultrasound — Baseline, 3 months, 6 months, 12 months, 18 months,…","Change in fear of falling — From baseline to 24 months, according to the study assessment schedule.","Change in adherence to the Mediterranean diet — From baseline to 24 months, according to the study assessment schedule.","Falls and fall-related consequences during follow-up — Throughout the 24-month follow-up period.","Percentage adherence to the VIVIFRAIL exercise program — Throughout the 24-month intervention period.","Change in cognitive performance assessed by the Montreal Cognitive Assessment (MoCA) — Baseline, 3 months, 6 months, 12…","Change in nutritional status assessed by the Mini Nutritional Assessment (MNA) — Baseline, 3 months, 6 months, 12 month…","Change in depressive symptoms assessed by the 15-item Geriatric Depression Scale (GDS-15) — Baseline, 3 months, 6 month…","Number of participants with functional near vision assessed using a simple visual acuity test — Baseline, 3 months, 6 m…","Number of participants with functional distance vision assessed using a simple visual acuity test — Baseline, 3 months,…","Number of participants with functional hearing assessed using the whispered voice test — Baseline, 3 months, 6 months,…","Change in muscle cross-sectional area assessed by musculoskeletal ultrasound — Baseline, 3 months, 6 months, 12 months,…","Change in muscle echo intensity assessed by musculoskeletal ultrasound — Baseline, 3 months, 6 months, 12 months, 18 mo…","Change in muscle ultrasound texture parameters — Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months."],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · NONE","source_has_results":false},"controlled_terms":["Falls","Frailty","VIVIFRAIL multicomponent exercise program","Mediterranean diet counselling","Extra virgin olive oil supplementation"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: exercise.","quality_checked_at":"2026-09-25T06:25:48.368501+00:00","duplicate_cluster_key":"id:nct07829484","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-06-10 to 2029-06-01","comparator":"VIVIFRAIL","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":"2026-09-25T06:25:45.679Z","intervention":["VIVIFRAIL multicomponent exercise program","Mediterranean diet counselling","Extra virgin olive oil supplementation"],"participants":140,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · NONE","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":["Change in usual gait speed — Baseline, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.","Change in physical performance assessed by the Short Physical Performance Battery (SPPB) — Baseline, 6 weeks, 3 months,…","Change in functional independence assessed by the Barthel Index — Baseline, 3 months, 6 months, 12 months, 18 months, a…","Change in health-related quality of life assessed by the EuroQol-5D — Baseline, 6 months, 12 months, 18 months, and 24…","Change in handgrip strength — From baseline to 24 months, according to the study assessment schedule.","Change in sarcopenia status — From baseline to 24 months, according to the study assessment schedule.","Change in muscle thickness assessed by musculoskeletal ultrasound — Baseline, 3 months, 6 months, 12 months, 18 months,…","Change in fear of falling — From baseline to 24 months, according to the study assessment schedule.","Change in adherence to the Mediterranean diet — From baseline to 24 months, according to the study assessment schedule.","Falls and fall-related consequences during follow-up — Throughout the 24-month follow-up period.","Percentage adherence to the VIVIFRAIL exercise program — Throughout the 24-month intervention period.","Change in cognitive performance assessed by the Montreal Cognitive Assessment (MoCA) — Baseline, 3 months, 6 months, 12…","Change in nutritional status assessed by the Mini Nutritional Assessment (MNA) — Baseline, 3 months, 6 months, 12 month…","Change in depressive symptoms assessed by the 15-item Geriatric Depression Scale (GDS-15) — Baseline, 3 months, 6 month…","Number of participants with functional near vision assessed using a simple visual acuity test — Baseline, 3 months, 6 m…","Number of participants with functional distance vision assessed using a simple visual acuity test — Baseline, 3 months,…","Number of participants with functional hearing assessed using the whispered voice test — Baseline, 3 months, 6 months,…","Change in muscle cross-sectional area assessed by musculoskeletal ultrasound — Baseline, 3 months, 6 months, 12 months,…","Change in muscle echo intensity assessed by musculoskeletal ultrasound — Baseline, 3 months, 6 months, 12 months, 18 mo…","Change in muscle ultrasound texture parameters — Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months."],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"exercise","is_published":true,"match_reasons":["Title contains controlled term: exercise.","Abstract contains controlled term: exercise.","Source terminology contains: exercise.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Exercise","slug":"exercise"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/15968","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}