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

Not Applicable

• Conditions: Cirrhosis, Liver; Sarcopenia
• Interventions: Dietary Supplement: CaHMB; Dietary Supplement: Placebo

• Registration Number: NCT03605147
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2018-07-22
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-07-30
• Study Start: 2018-08-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CaHMB	CaHMB	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.
Control	Placebo	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China