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

September 25, 2018 updated by: Shanghai Zhongshan Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Shiyao Chen, doctor
  • Phone Number: 86 13601767310
  • Email: syaochen@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Shanghai Zhongshan Hospital
        • Contact:
          • Ji Zhou, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Dietary supplement: CaHMB
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.
ACTIVE_COMPARATOR: Control
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in skeletal muscle mass
Time Frame: 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)
Baseline and 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Chair: Shiyao Chen, doctor, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 22, 2018

Primary Completion (ANTICIPATED)

July 1, 2019

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

July 22, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (ACTUAL)

July 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIR-CAHMB-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcopenia

Clinical Trials on CaHMB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe