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

Fudan University

Status: Unknown

Conditions: Cirrhosis, Liver; Sarcopenia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: CaHMB

Study type: Interventional

Funder types: Other

Identifiers

NCT03605147

CIR-CAHMB-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

CaHMB

Experimental group

Description:

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.

Treatment:

Dietary Supplement: CaHMB

Control

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo