The Effect of Calcium β-hydroxy-β-methylbutyrate (CaHMB) Supplementation in Sarcopenia in Liver Cirrhosis

Shanghai Zhongshan Hospital120 enrolled

Overview

This study is to evaluate the effect of CaHMB in the treatment of sarcopenia in liver cirrhosis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Sarcopenia Cirrhosis, Liver

Interventions

CaHMBDIETARY_SUPPLEMENT

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.

PlaceboDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Changes in skeletal muscle mass

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)