The goal of this clinical trial is to learn if silkworm pupa powder works to improve the nutritional status of Alzheimer's disease patients. The main questions it aims to answer are: * Does silkworm pupa powder evaluate the effectiveness of silkworm pupae in improving sarcopenia, frailty and quality of life in AD patients? * Does silkworm pupa powder improve cognitive function in AD patients? Researchers will compare silkworm pupa powder to a placebo (a look-alike substance that contains no drug) to see if silkworm pupa powder works to improve the nutritional status of Alzheimer's disease patients. Participants will: * Take drug silkworm pupa powder or a placebo every day for 3 months. * Visit the clinic once every 4 weeks for checkups and tests. * Keep a diary of their daily consumption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Silkworm pupa powder, 2 times a day, two packets (12\*2 g) each time, take with warm water, before meals, for three months
Placebo, 2 sachets (12\*2 g) twice a day, with warm water, before meals, for three months
Zhejiang Hospital
Hangzhou, Zhejiang, China
RECRUITINGHemoglobin
Take blood testing and detect hemoglobin levels
Time frame: The 4th 、8th and 12th week after taking Silkworm
Albumin
Detect blood albumin levels
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Serum prealbumin
Detect serum prealbumin levels
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
25-hydroxyvitamin D
Detect blood 25-hydroxyvitamin D levels
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Alkaline phosphatase
Detect blood alkaline phosphatase levels
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Parathyroid hormone
Detect parathyroid hormone levels
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Calcitonin
Detect calcitonin levels
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Whole abdominal Computerized tomography (CT) scan
Take the whole abdominal CT scan
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Diagnostic criteria of the 2019 Asian Sarcopenia Working Group
Evaluate sarcopenia again
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Mini-mental State Examination(MMSE) Scale
Take the MMSE Scale again
Time frame: The 4th、8th and 12th week after taking placebo.
Clinical Dementia Rating(CDR) Scale
Take the CDR Scale again
Time frame: The 4th 、8th and 12th week after taking placebo.
Eastern Cooperative Oncology Group Score
Take the ECOG Score again
Time frame: The 4th 、8th and 12th week after taking placebo.
Head Magnetic Resonance Scan
Take Head MR again
Time frame: The 4th 、8th and 12th week after taking placebo.
Amyloid β-protein(Aβ)
Detect the blood Amyloid β-protein levels, include Aβ42、Aβ40、Aβ40/42
Time frame: The 4th 、8th and 12th week after taking placebo.
Phosphorylated microtubule-associated protein Tau(P-Tau)
Detect the Phosphorylated microtubule-associated protein Tau levels, include P-tau181、P-tau 217
Time frame: The 4th 、8th and 12th week after taking placebo.
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