{"type":"trials","record":{"id":22529,"source_id":"clinicaltrials-gov","external_id":"NCT04985877","title":"Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota in Sarcopenia Elderly","brief_summary":"Sarcopenia, which refers to the progressive loss of skeletal muscle mass and strength, shares many characteristics with other disease states typically associated with risks of falling and fracture, including osteoporosis, frailty, and obesity. Sarcopenia often is linked to an increase in connective tissue, muscle steatosis, impaired muscle metabolism, an increase in inflammatory markers, an increased stiffness of myofibers, slower kinetics in establishing myosin-actin crossing bridges, increased oxidative stress, mitochondria dysfunction, hormonal imbalance, and decreased capillary flow. In addition to the Lactobacillus casei strain, Shirota is a well-known probiotic strain that has been approved and is generally recognized as safe by the United States Food and Drug Administration. L. casei strain Shirota (LCS) has been suggested to confer health benefits. Investigators found that LCS decelerated age-related muscle loss via ensuring mitochondrial function in Senescence-Accelerated Mouse Prone 8 (SAMP8) mice. Investigators also found that 3-Indolepropionic Acid (IPA) is a microbiota-derived metabolite from a healthy intestinal gut. IPA is also a protective factor for the progression of chronic kidney disease in the Chinese population. This clinical trial focuses on the effect of fermented milk containing LCS on sarcopenia in elderly Taiwanese individuals. Investigators focus on the topic of the interaction of LCS with the diversity of the gut microbiota, microbiota-derived metabolites, and protein utilization. The proposal will have four research goals. First, investigators try to investigate whether long term supplementation LCS could restructure the gut microbiota composition and gut microbial metabolites to against Aging related -Gut Dysbiosis in elderly. Second, investigators also try to link the LCS play an important role on muscle loss and alternation of gut microbiota composition. Third, investigators try to study the LCS effect of muscle deterioration with aging, and highlight the two underpinning mechanisms (ROS and protein utilization) regulating declines in muscle mass and function. Fourth, Since IPA is important Microbiota-derived metabolites in health gut, investigators try to investigate whether LCS could play an important role on modulation of IPA production in GI. Fifth, investigators hope that investigators can through gut microbiota composition found some selective microbiota clusters perform positively correlation with IPA.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Taipei Medical University","enrollment":132,"countries":["Taiwan"],"start_date":"2021-03-23","completion_date":"2023-02-23","last_update_date":"2026-02-17","source_url":"https://clinicaltrials.gov/study/NCT04985877","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":"2026-09-24T02:17:02.944409+00:00","last_seen_at":"2026-09-25T06:20:19.667+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years to 85 Years","comparator":"Sarcopenia group(SC); non-sarcopenia group(NS)","organization":"Taipei Medical University","interventions":["Yakult 300 LIGHT Fermented Milk"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Impact of LCS on the Change of Gut Microbiota — 12 week","Impact of LCS on the Change of Sarcopenia Markers (Handgrip) — 12 week","Impact of LCS on the Change of Sarcopenia Markers (Walk Speed) — 12 weeks","Impact of LCS on the Change of Sarcopenia Markers (Chair Stand Test & TUG Test) — 12 week","Impact of LCS on the Change of Sarcopenia Markers (SPPB Score) — 12 weeks","Impact of LCS on the Change of Inflammatory Biomarker — 12 week","Impact of LCS on the Change of Anti-oxidant Biomarker — 12 week"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":true},"controlled_terms":["Sarcopenia","Inflammation","Aging","Yakult 300 LIGHT Fermented Milk"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: sarcopenia.","quality_checked_at":"2026-09-25T06:20:27.00315+00:00","duplicate_cluster_key":"id:nct04985877","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-03-23 to 2023-02-23","comparator":"Sarcopenia group(SC); non-sarcopenia group(NS)","confidence":"structured-source","population":"ALL · 65 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":"2026-09-25T06:20:19.693Z","intervention":["Yakult 300 LIGHT Fermented Milk"],"participants":132,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · 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":["Impact of LCS on the Change of Gut Microbiota — 12 week","Impact of LCS on the Change of Sarcopenia Markers (Handgrip) — 12 week","Impact of LCS on the Change of Sarcopenia Markers (Walk Speed) — 12 weeks","Impact of LCS on the Change of Sarcopenia Markers (Chair Stand Test & TUG Test) — 12 week","Impact of LCS on the Change of Sarcopenia Markers (SPPB Score) — 12 weeks","Impact of LCS on the Change of Inflammatory Biomarker — 12 week","Impact of LCS on the Change of Anti-oxidant Biomarker — 12 week"],"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/22529","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}