Improving nutritional status and frailty in patients with motor neuron disease using silkworm pupa powder

A Prospective, Double-blind, Randomized Controlled Study Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Powder Compared With Placebo Among Motor Neuron Disease

This study is testing if adding silkworm pupa powder to the diets of people with motor neuron disease, like ALS, can help improve their nutrition, muscle strength, and overall health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: First People's Hospital of Hangzhou (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06765499 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of silkworm pupa powder on the nutritional status and frailty of patients diagnosed with motor neuron disease, particularly amyotrophic lateral sclerosis (ALS). The intervention involves administering either standard or ultra-low doses of silkworm pupa powder to participants who meet specific eligibility criteria. The study aims to assess improvements in muscle strength, weight, and overall health status among these patients. Participants will also provide biological samples for further analysis during the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 diagnosed with ALS who exhibit signs of frailty.

Not a fit: Patients with other neurological diseases or conditions that mimic ALS symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could enhance the nutritional status and reduce frailty in patients with motor neuron disease, potentially improving their quality of life.

How similar studies have performed: While the use of silkworm pupa powder is a novel approach, similar studies focusing on nutritional interventions in ALS have shown promising results.

Eligibility criteria

Inclusion Criteria:

* Voluntarily participate in the clinical study, fully understand and be informed about the study, and sign the Informed Consent Form (ICF); willing to follow and capable of completing all trial procedures.
* Gender is not limited, age at the time of signing ICF: ≥18 years old, ≤80 years old; if the ALS patient is at least 18 years old, then the weight must be over 40 kilograms.
* Diagnosis conforms to the confirmed and probable ALS in the ALS2020 diagnostic criteria (Gold Coast Criteria).
* Clinical, neurophysiological, or pathological examination confirms evidence of lower motor neuron involvement.
* Frailty Phenotype scale (FP) ≥1.
* Exclude other diseases.
* Agree to provide peripheral blood, fecal, and urine samples for biomarker analysis during the study period.

Exclusion Criteria:

* Patients with other neurological diseases similar to ALS symptoms or affecting drug efficacy evaluation, such as cervical spondylosis, lumbar disease, dementia, etc.
* Patients with other autoimmune diseases, such as Multiple Sclerosis (MS), Polymyositis, Myasthenia Gravis, Guillain-Barré Syndrome, Ankylosing Spondylitis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vitiligo, etc.
* Severe renal insufficiency: Creatinine clearance \< 30 mL/min (Cockcroft-Gault formula), or other known severe renal insufficiency diseases.
* Severe liver damage: ALT, AST \> 3 times the upper limit of normal, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis, etc.
* Patients with severe pulmonary function insufficiency such as Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis, etc.
* During the screening period, patients with acute myocardial infarction or interventional treatment within the last 6 months, heart failure patients (classified as NYHA class III-IV patients).
* Patients with other severe primary diseases of the nervous system, heart, lungs, hematopoietic system, or endocrine system, and mental illness patients.
* Those suspected or confirmed to have a history of alcohol or drug abuse.
* Expected survival ≤ 3 months.
* Pregnant or breastfeeding women, subjects of reproductive age (including male subjects who have had heterosexual intercourse and their female partners with childbearing potential) who plan to become pregnant or are unwilling to take effective contraceptive measures from the start of screening to 3 months after discontinuing medication.
* Those who are allergic to known ingredients of the trial products; or have a history of drug allergies or severe allergic diseases (anaphylactic shock, etc.).
* During the study, individuals assessed by researchers as potential drug abusers who may affect the efficacy of therapeutic drugs.
* Presence of other severe physical or mental diseases or abnormal laboratory tests that may increase the risk of participating in the study and patients deemed unsuitable for participation by the researcher.
* Patients with malignant tumors.

Where this trial is running

Hangzhou, Zhejiang

• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Ma Buqing Attending Physician

Conditions Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Frailty; Nutritional Status