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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Hangzhou First People's Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Ma Buqing Attending Physician
757318708@qq.com
0571-56007429
Time Frame
Start Date: 2025-03-04
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 100
Treatments
Experimental: Silkworm pupa powder
The intervention in the trial involves providing silkworm pupa powder, twice a day, with two packets each time, to be taken before meals.The dose of gastrointestinal weak people was halved, twice a day, 1 pack each time, half an hour before breakfast and dinner.
Placebo_comparator: Placebo
The intervention for the placebo group involves administering a placebo containing 0.5% of the active ingredient, twice daily, with two packets each time, taken before meals.The dose of gastrointestinal weak people was halved, twice a day, 1 pack each time, half an hour before breakfast and dinner.
Sponsors
Leads: First People's Hospital of Hangzhou
Collaborators: Hangzhou Institute of Medicine Chinese Academy of Sciences

This content was sourced from clinicaltrials.gov