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

Study Overview
=================
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.

Official Title
-----------------
The Effect of Calcium β-hydroxy-β-methylbutyrate Supplementation in Sarcopenia in Liver Cirrhosis：A Randomized Double-blind Controlled Trial

Conditions
-----------------
Sarcopenia, Cirrhosis, Liver

Intervention / Treatment
-----------------
* Dietary Supplement: CaHMB
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed of cirrhosis with imaging or liver biopsy; diagnosis of portal hypertension with endoscopy or radiography； assessed total muscle mass at the level of L3 (<42 cm2/m2 for male and <38 cm2/m2 for female) has signed an informed consent form. Exclusion Criteria: diagnosed as hepatic cell cancer; complicated with malignancy, renal failure, diabetes mellitus; comorbidities including heart failure or pulmonary disease; current use of drugs that affect skeletal muscle metabolism; be allergic to the experimental food; participated other clinical trials in the past 3 months; other conditions that researchers consider not suitable for this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CaHMB<br>CaHMB Group (n=60) will receive CaHMB twice a day and a late evening snack every night for 12 weeks. A specialized, ready-to-drink liquid with 34 kcal, 8.5 g carbohydrate, 1.5g calcium-HMB. The late evening snack is a drink with low-Glycemic Index carbohydrate with 112 kcal. | Dietary Supplement: CaHMB<br>* 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.<br>|
| Active Comparator: Control<br>Control Group (n=60) will receive placebo twice a day and placebo every night for 12 weeks with similar composition but without HMB. The late evening snack is a drink with low-Glycemic Index carbohydrate with 112 kcal. | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total body weight | Change of total body weight . | Baseline and 12 weeks | 
| Grip strength | Changes of grip strength of both hands measured with a grip dynamometer | Baseline and 12 weeks | 
| Protein metabolic markers | Changes of protein metabolic makers | Baseline and 12 weeks | 
| Changes in intramuscular fat deposition | Changes of mean muscle attenuation (MA) at the level of L3 in CT | Baseline and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HMB, sarcopenia, liver cirrhosis, chronic liver disease, malnutrition, muscle wasting