sarcopenia
Conditions
Interventions
Test group:Milk powder containing hydrolyzed whey protein and HMB
Control group:Milk powder containing hydrolyzed whey protein
Blank group:Normal diet
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 60 years; 2. Five-item Simple Sarcopenia Screening Scale (arcopenia-Five, SARC-F) total score >= 2 points, each item score is 0~2 points: (1) Strength: the degree of difficulty of lifting or holding 5 kg items (such as rice or noodles); (2) Walking assistance: the degree of difficulty in walking around the room; (3) Sitting up from a chair: the degree of difficulty in getting up from a chair or bed; (4) Going up steps: the degree of difficulty in climbing 10 steps; (5) Falls: the number of falls in the past 1 year; 3. Acceptable dairy product intervention; 4. Willing to sign informed consent after subject education, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women; 2. Suffering from acute or chronic diseases, including but not limited to cardiovascular, gastrointestinal, liver, kidney, endocrine system, respiratory system, nervous system and skin, as judged by the investigator; 3. Past or existing family history of any blood system disease or disorder, major liver disease, bleeding disease/platelet disease; 4. Previously or currently suffering from cancer (except basal cell carcinoma or squamous cell carcinoma of the skin), rheumatism or dyscrasia; 5. Any history of surgery or disease that may significantly change drug absorption, distribution, metabolism, and excretion, including but not limited to the following: (1) Inflammatory bowel disease, peptic ulcer, gastrointestinal (including rectal) bleeding, irritable bowel syndrome; (2) major gastrointestinal surgery, such as gastrectomy, gastroenterostomy, cholecystectomy or bowel resection; (3) Pancreatic injury or pancreatitis; 6. Have a history of fever within 14 days before the first administration; 7. Those who have a positive alcohol screen or urine drug screen during screening or admission assessment, or have a history of alcohol abuse or drug abuse in the past five years (alcohol abuse history is defined as: drinking more than 28 units of alcohol per week in the past 3 months[ 1 unit = 285 mL of beer/25mL of spirits/1 glass of wine] or drinking alcohol 48 hours before the test; drug abuse was defined as the use of soft drugs [such as marijuana] in the 3 months before the test or the use of hard drugs in the 1 year before the test [eg: cocaine, etc.] or positive urine drug test); 8. Those who smoked more than 5 cigarettes per day within 3 months before the first administration or could not abide by the no-smoking regulations during the study period (positive for cotinine/nicotine during screening or admission assessment); 9. Those with abnormal laboratory test values ??at the time of screening or admission evaluation and judged by the investigator to have clinical significance; 10. The total white blood cell count or absolute lymphocyte count exceeds the normal range, and the hemoglobin or platelet is lower than the lower limit of the normal range (LLN) at the time of screening or admission evaluation; 11. The following laboratory test values ??are higher than the upper limit of normal value at the time of screening or admission evaluation: alanine aminotransferase (ALT/SGPT), alkaline phosphatase (ALP), aspartate aminotransferase (AST/SGOT) ; 12. The test results of hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, HIV (HIV), Treponema pallidum, and new coronavirus are positive; 13. Suffering from autoimmune disease, immunosuppression or any form of immunodeficiency; 14. Any of the following: (1) Confirmed by re-testing, the heart rate-corrected QT interval (QTc) calculated by Fridericias formula is > 450ms; (2) Confirmed by retest, QRS > 110 ms; (3) Confirmed by retest, PR interval > 220 ms; (4) There are conditions that make QTc measurement difficult or QTc data cannot be interpreted; (5) There are other risk factors for torsades de ventricular tachycardia (such as heart failure, hypokalemia, family history of prolonged QT syndrome); 15. Those who have taken any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before the first administration; 16. Those who have participated in other clinical studies and received study drug t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters for ASC10, ASC10-A (also known as NHC, a metabolite of ASC10), and monupivir (a metabolite of ASC10); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation index; | — |
Countries
China
Contacts
Public ContactPing Zeng
Beijing Hospital
Outcome results
None listed