Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06765499

The Study Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Powder Among Patients With Motor Neuron Disease

Led by First People's Hospital of Hangzhou · Updated on 2025-05-04

100

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

F

First People's Hospital of Hangzhou

Lead Sponsor

H

Hangzhou Institute of Medicine Chinese Academy of Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Study Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Powder Among Patients With Motor Neuron Disease

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and sign informed consent
  • Age between 18 and 80 years old
  • Weight over 40 kilograms if diagnosed with ALS
  • Diagnosed with confirmed or probable ALS using ALS2020 diagnostic criteria (Gold Coast Criteria)
  • Clinical, neurophysiological, or pathological evidence of lower motor neuron involvement
  • Frailty Phenotype scale score of 1 or higher
  • No other diseases that could interfere with the study
  • Agree to provide blood, fecal, and urine samples for biomarker analysis during the study
Not Eligible

You will not qualify if you...

  • Presence of other neurological diseases similar to ALS symptoms or affecting treatment evaluation (e.g., cervical spondylosis, lumbar disease, dementia)
  • Presence of autoimmune diseases such as Multiple Sclerosis, Polymyositis, Myasthenia Gravis, Guillain-Barré Syndrome, Ankylosing Spondylitis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vitiligo
  • Severe kidney failure with creatinine clearance less than 30 mL/min or other severe renal diseases
  • Severe liver damage with ALT or AST more than three times the normal limit or other liver diseases (e.g., hepatitis, cirrhosis)
  • Severe lung diseases like Chronic Obstructive Pulmonary Disease or pulmonary fibrosis
  • Recent (within 6 months) heart attack or interventional heart treatment, or severe heart failure (NYHA class III-IV)
  • Other severe diseases of the nervous, heart, lung, blood, or endocrine systems, or mental illness
  • History or suspicion of alcohol or drug abuse
  • Expected survival of 3 months or less
  • Pregnant or breastfeeding women, or those not using effective contraception from screening to three months after study end
  • Allergy to study product ingredients or history of severe allergic reactions
  • Individuals assessed as potential drug abusers during the study
  • Other serious physical or mental conditions or abnormal lab tests making participation unsafe
  • Presence of malignant tumors

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

M

Ma Buqing Attending Physician

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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