{"type":"trials","record":{"id":50,"source_id":"clinicaltrials-gov","external_id":"NCT06645847","title":"Targeting Aging With a Ketone Ester for Function in Frailty","brief_summary":"This study aims to find out if a food supplement that contains a naturally occurring substance, ketones, can help to improve strength and general wellness in adults at, or over the age of 65 years who are experiencing a slight decline in their physical function. Participation will involve a screening visit and 4 additional study visits over the course of 20 weeks. After being assessed for eligibility, study participants will be sorted into two groups at random and consume either a ketone or placebo supplement at home every day for 20 weeks. Both study products can cause gastro-intestinal side effects in some individuals. At all study visits, subjects will provide blood samples. At three study visits, subjects will be asked to complete physical performance tests, provide blood, stool and urine samples. They will also complete questionnaires during three study visits to assess physical function, markers of inflammation, and other aspects of general well-being. The study enrolls at three sites across the United States, in California (Buck Institute), Ohio (Ohio State University), and Connecticut (University of Connecticut). The study is coordinated by the San Francisco Coordinating Center (California Pacific Medical Center).","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Buck Institute for Research on Aging","enrollment":180,"countries":["United States"],"start_date":"2025-04-17","completion_date":"2028-04-01","last_update_date":"2026-09-09","source_url":"https://clinicaltrials.gov/study/NCT06645847","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":"2026-09-14T02:44:59.105435+00:00","last_seen_at":"2026-09-25T06:15:06.064+00:00","metadata":{"sex":"ALL","acronym":"TAKEOFF","age_range":"65 Years","comparator":"Ketone ester; Non-ketone placebo","organization":"Buck Institute for Research on Aging","interventions":["Ketone ester","Placebo Comparator: Non-ketone placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Frailty composite score — Baseline, 12 weeks, 20 weeks","Tolerability key symptom index — 20 weeks","Safety Lab Tests — Baseline, Week 4, Week 12, 20 weeks","Leg fatigue - leg press at sub maximal weight — 20 weeks","Short Physical Performance Battery — Baseline, Week 12, 20 weeks","Grip Strength — Baseline, Week 12, Week 20","Montreal Cognitive Assessment — Baseline, 12 weeks, 20 weeks","Trails A and B — Baseline, Week 12, Week 20"],"design_description":"RANDOMIZED · PARALLEL · BASIC SCIENCE · QUADRUPLE","source_has_results":false},"controlled_terms":["Frail Elderly","Aging","Immune Function","Muscle Function","Ketone ester","Placebo Comparator: Non-ketone placebo"],"relevance_confidence":80,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:15:09.632521+00:00","duplicate_cluster_key":"id:nct06645847","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-04-17 to 2028-04-01","comparator":"Ketone ester; Non-ketone placebo","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":"2026-09-25T06:15:06.069Z","intervention":["Ketone ester","Placebo Comparator: Non-ketone placebo"],"participants":180,"study_design":"RANDOMIZED · PARALLEL · BASIC SCIENCE · QUADRUPLE","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":["Frailty composite score — Baseline, 12 weeks, 20 weeks","Tolerability key symptom index — 20 weeks","Safety Lab Tests — Baseline, Week 4, Week 12, 20 weeks","Leg fatigue - leg press at sub maximal weight — 20 weeks","Short Physical Performance Battery — Baseline, Week 12, 20 weeks","Grip Strength — Baseline, Week 12, Week 20","Montreal Cognitive Assessment — Baseline, 12 weeks, 20 weeks","Trails A and B — Baseline, Week 12, Week 20"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Title supplies longevity context: aging, frailty.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/50","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}