Cirrhosis, Liver, Sarcopenia
Conditions
Keywords
HMB, sarcopenia, liver cirrhosis, chronic liver disease, malnutrition, muscle wasting
Brief summary
This study is to evaluate the effect of CaHMB in the treatment of sarcopenia in liver cirrhosis.
Detailed description
The study is a randomized double-blind controlled trial. Patients randomly enter into two treatment groups: 1) the CaHMB group and 2) the placebo group. Treatment allocation is by block randomization, with an one-to-one ratio for CaHMB and placebo. The results are concealed in opaque envelopes. Patients will report their daily diets with an online software. Patients will come for clinic after 4 weeks and 12 weeks, receiving laboratory tests and sarcopenia evaluation, and events of primary and secondary outcomes will be analyzed.
Interventions
DIETARY_SUPPLEMENTCaHMB
Supplements, labeled only with the identification number of the participant, will be provided to the participants in the Department of Gastroenterology of Zhongshan Hospital. After 4 weeks, subjects will receive medical center visit to evaluate the compliance and side effects. After 12 weeks, changes in body composition will be assessed by abdominal CT. An online application will be used to monitor the compliance everyday.Their diets will be recorded by a nutritionist. Blood will be collected pre- and post treatment. Extensive laboratory tests will be performed.
DIETARY_SUPPLEMENTPlacebo
Supplements, labeled only with the identification number of the participant, will be provided to the participants in the Department of Gastroenterology of Zhongshan Hospital. After 4 weeks, subjects will receive medical center visit to evaluate the compliance and side effects. After 12 weeks, changes in body composition will be assessed by CT. An online application will be used to monitor the compliance everyday.Their diets will be recorded by a nutritionist. Blood will be collected pre- and post treatment. Extensive laboratory tests will be performed.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. diagnosed of cirrhosis with imaging or liver biopsy; 2. diagnosis of portal hypertension with endoscopy or radiography； 3. assessed total muscle mass at the level of L3 (\<42 cm2/m2 for male and \<38 cm2/m2 for female) 4. has signed an informed consent form.
Exclusion criteria
1. diagnosed as hepatic cell cancer; 2. complicated with malignancy, renal failure, diabetes mellitus; 3. comorbidities including heart failure or pulmonary disease; 4. current use of drugs that affect skeletal muscle metabolism; 5. be allergic to the experimental food; 6. participated other clinical trials in the past 3 months; 7. other conditions that researchers consider not suitable for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in skeletal muscle mass | Baseline and 12 weeks | Changes of total muscle mass at the level of L3 in CT, analysed by the total cross-sectional area of muscle in centimetres squared (cm2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in total body weight | Baseline and 12 weeks | Change of total body weight . |
| Grip strength | Baseline and 12 weeks | Changes of grip strength of both hands measured with a grip dynamometer |
| Protein metabolic markers | Baseline and 12 weeks | Changes of protein metabolic makers |
| Changes in intramuscular fat deposition | Baseline and 12 weeks | Changes of mean muscle attenuation (MA) at the level of L3 in CT |
Countries
China
Contacts
Primary ContactJi Zhou, doctor
Backup ContactShiyao Chen, doctor
Outcome results
None listed