{"type":"trials","record":{"id":33747,"source_id":"clinicaltrials-gov","external_id":"NCT05485402","title":"Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)","brief_summary":"The main objective of the present study is to add knowledge of the potential health effects and mechanism of action by a dietary strategy based on a VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or combination with prebiotic supplementation based on fructooligosaccharides (FOS) and inulin to tackle sarcopenia by improving skeletal muscle mass and function and CVD risk factors in early elderly (60-80 years) home-dwelling sarcopenic subjects. The specific objectives: * To determine the compliance food intake biomarkers of VOO in 24h urine samples and prebiotic intake in faecal samples. * To evaluate the effect of the NFOC-diet supplemented by VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or in combination with prebiotic supplementation (FOS and inulin) on the improvement of muscle mass, muscle performance, gait performance, cardiovascular disease risk factors (inflammation, oxidation and endothelial function), and gut microbiota, in sarcopenic young-elderly subjects. * To assess the mechanisms of action of the NFOC-diet supplemented by VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or in combination with prebiotic supplementation (FOS and inulin) involved in the development of sarcopenia and cardiovascular disease in vivo and in vitro cellular models. * To determine if the effects achieved after the intervention (12 weeks of intervention) will be sustained 12 weeks after the FOOP-Sarc intervention cessation (12 weeks of intervention + 12 weeks of follow-up), by assessing the sarcopenia and CVD risk factors in sarcopenic early elderly subjects. * To co-create nutritional and physical activity recommendations of FOOP-Sarc study based on sarcopenia improvement by a sample of volunteers of the FOOP-Sarc study, and to assess the adherence and the effectivity of the recommendations, in comparison to standard recommendations created by researchers, the satisfaction and engagement experience in a co-creation process, and the usability of recommendations.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University Rovira i Virgili","enrollment":39,"countries":["Spain"],"start_date":"2022-09-01","completion_date":"2024-05-31","last_update_date":"2025-12-22","source_url":"https://clinicaltrials.gov/study/NCT05485402","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:11.953004+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":"FOOP-Sarc","age_range":"60 Years to 80 Years","comparator":"Control group (Group A)","organization":"University Rovira i Virgili","interventions":["Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil)","Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil)","Maltodextrin","Prebiotic (FOS and inulin)","Nutritional and physical activity recommendations"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in muscle mass — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Body-weight — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Height — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Body Mass Index — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Body weight composition — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Waist circumference — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Sarcopenia assessment_skeletal muscle strength — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week…","Sarcopenia assessment_muscle mass — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Sarcopenia assessment_muscle physical performance — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (we…","Compliance of physical activity recommendations — Visit 1 (week 0), visit 2 (week 3), visit 3 (week 6), visit 4 (week 9…","Compliance of the dietary recommendations — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Dietary compliance markers — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Specific phenolic compounds_dietary compliance markers — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Phenolic metabolites_dietary compliance markers — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Sarcopenia and Quality of life — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Fasting blood glucose (FBG) — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Insulin — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Homeostasis model assessment index (HOMA index) — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Lipid profile — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Apolipoproteins — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · TRIPLE","source_has_results":false},"controlled_terms":["Sarcopenia","Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil)","Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil)","Maltodextrin","Prebiotic (FOS and inulin)","Nutritional and physical activity recommendations"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: sarcopenia.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct05485402","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-09-01 to 2024-05-31","comparator":"Control group (Group A)","confidence":"structured-source","population":"ALL · 60 Years to 80 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":"2026-09-25T06:10:25.806Z","intervention":["Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil)","Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil)","Maltodextrin","Prebiotic (FOS and inulin)","Nutritional and physical activity recommendations"],"participants":39,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · TRIPLE","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 muscle mass — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Body-weight — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Height — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Body Mass Index — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Body weight composition — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Waist circumference — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Sarcopenia assessment_skeletal muscle strength — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week…","Sarcopenia assessment_muscle mass — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Sarcopenia assessment_muscle physical performance — Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (we…","Compliance of physical activity recommendations — Visit 1 (week 0), visit 2 (week 3), visit 3 (week 6), visit 4 (week 9…","Compliance of the dietary recommendations — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Dietary compliance markers — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Specific phenolic compounds_dietary compliance markers — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Phenolic metabolites_dietary compliance markers — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Sarcopenia and Quality of life — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Fasting blood glucose (FBG) — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Insulin — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Homeostasis model assessment index (HOMA index) — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Lipid profile — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)","Apolipoproteins — Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"sarcopenia","is_published":true,"match_reasons":["Title contains controlled term: sarcopenia.","Abstract contains controlled term: sarcopenia.","Source terminology contains: sarcopenia.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sarcopenia","slug":"sarcopenia"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/33747","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}