{"type":"trials","record":{"id":33136,"source_id":"clinicaltrials-gov","external_id":"NCT06765499","title":"The Study Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Powder Among Patients With Motor Neuron Disease","brief_summary":"Motor Neuron Disease (MND) is the result of dysfunction of the upper motor neurons in the precentral gyrus of the frontal lobe or the lower motor neurons in the ventral horn of the spinal cord. Amyotrophic lateral sclerosis (ALS) is the most common, disabling, and fatal motor neuron disease in adults. Sarcopenia is a syndrome characterized by progressive loss of skeletal muscle mass, accompanied by a reduction in muscle strength and (or) function, and it is an important feature of MND. Aging is an objective and inevitable process that involves the gradual degeneration and loss of physiological functions in various tissues, organs, and cells. With the continuous accumulation of various injuries, the body eventually exhibits signs of frailty such as fatigue, reduced muscle strength, and weight loss. Data from adult ALS patients indicate that 58% of patients are at risk of frailty. Silkworm pupa contains high-quality animal protein and has a wide range of activities in antioxidant, antitumor, antibacterial, and immune enhancement, making it highly nutritious and medicinally valuable. Silkworm pupa extracts can enhance grip strength in older adults with relatively low skeletal muscle mass. As a natural food ingredient with high safety, the value of silkworm pupa in ALS patients lacks corresponding research, which limits its further application in clinical practice. This study aims to select ALS patients as the research subjects and use a randomized, controlled, double-blind prospective study design to evaluate the effectiveness of silkworm pupa tablets in improving sarcopenia, frailty, and quality of life in ALS patients. The study strives to improve the frailty condition of ALS patients and enhance their quality of life by supplementing nutrition, thereby providing new strategies for comprehensive intervention and management of ALS patients.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"First People's Hospital of Hangzhou","enrollment":100,"countries":["China"],"start_date":"2025-03-04","completion_date":"2026-12-30","last_update_date":"2025-05-04","source_url":"https://clinicaltrials.gov/study/NCT06765499","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":"2026-09-25T01:20:07.921608+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"18 Years to 80 Years","comparator":"Placebo","organization":"First People's Hospital of Hangzhou","interventions":["Chinese medicine - Silkworm pupa powder","Ultra-low dose silkworm pupa powder"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Assessing patient nutritional improvement using Third Lumbar Skeletal Muscle Index (L3-SMI). — The 0th、 4th 、8th and 12…","The improvement of frailty in patients treated by the Frailty Phenotype (FP) Scale assessment. — The 0th、 4th 、8th and…","Using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) to assess patient functional status,…","Assess the respiratory function of patients with Amyotrophic Lateral Sclerosis undergoing treatment using the Oxygenati…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Motor Neuron Disease (MND)","Amyotrophic Lateral Sclerosis (ALS)","Chinese medicine - Silkworm pupa powder","Ultra-low dose silkworm pupa powder"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct06765499","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-03-04 to 2026-12-30","comparator":"Placebo","confidence":"structured-source","population":"ALL · 18 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":"2026-09-25T06:10:25.825Z","intervention":["Chinese medicine - Silkworm pupa powder","Ultra-low dose silkworm pupa powder"],"participants":100,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · 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":["Assessing patient nutritional improvement using Third Lumbar Skeletal Muscle Index (L3-SMI). — The 0th、 4th 、8th and 12…","The improvement of frailty in patients treated by the Frailty Phenotype (FP) Scale assessment. — The 0th、 4th 、8th and…","Using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) to assess patient functional status,…","Assess the respiratory function of patients with Amyotrophic Lateral Sclerosis undergoing treatment using the Oxygenati…"],"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.","Abstract contains controlled term: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/33136","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}