{"type":"trials","record":{"id":33938,"source_id":"clinicaltrials-gov","external_id":"NCT02811445","title":"Role of the Gut Microbiome on Lean Mass and Physical Function in Older Adults","brief_summary":"The investigators recently published significant associations between circulating gut bacteria-related metabolites with lean and skeletal muscle mass and with measures of physical function in older adults, evidence that suggests a role for gut bacteria on the maintenance of these outcomes. To date, studies aimed at identification of associations between gut bacteria with lean mass or with specific measures of physical function have yet to be reported. Accordingly, the over-arching hypothesis is that gut bacteria are associated with, and are causatively involved in mechanisms that underlie the maintenance of lean mass and physical function in older adults. Results obtained from the proposed study are intended as the basis for future studies aimed at targeted modulation of the gut microflora, which may be a novel and innovative means for improving lean mass and physical function, and for addressing the public health priority of healthy aging in older adults.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Tufts University","enrollment":29,"countries":["United States"],"start_date":"2016-05-01","completion_date":"2019-11-01","last_update_date":"2020-08-06","source_url":"https://clinicaltrials.gov/study/NCT02811445","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":null,"age_range":"70 Years to 85 Years","comparator":null,"organization":"Tufts University","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Percentage of Whole Body Lean Mass (%WBLM) — 1 month","Physical Function Measurement — 1-month","400-meter Gait Speed — 1-month","Leg Press 1 Repetition Maximum — 1-month"],"design_description":null,"source_has_results":true},"controlled_terms":["Sarcopenia"],"relevance_confidence":80,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: microbiome.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct02811445","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2016-05-01 to 2019-11-01","comparator":null,"confidence":"structured-source","population":"ALL · 70 Years to 85 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":"2026-09-25T06:10:25.884Z","intervention":[],"participants":29,"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":["Percentage of Whole Body Lean Mass (%WBLM) — 1 month","Physical Function Measurement — 1-month","400-meter Gait Speed — 1-month","Leg Press 1 Repetition Maximum — 1-month"],"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: microbiome.","Title supplies longevity context: older adult.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"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/33938","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}