Back to resultsThe Effect of Calcium β-hydroxy-β-methylbutyrate (CaHMB) Supplementation in Sarcopenia in Liver Cirrhosis (CaHMB)
Primary Purpose
Sarcopenia, Cirrhosis, Liver
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CaHMB
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia focused on measuring HMB, sarcopenia, liver cirrhosis, chronic liver disease, malnutrition, muscle wasting
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
Sites / Locations
- Shanghai Zhongshan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CaHMB
Control
Arm 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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Changes in total body weight
Change of total body weight .
Grip strength
Changes of grip strength of both hands measured with a grip dynamometer
Protein metabolic markers
Changes of protein metabolic makers
Changes in intramuscular fat deposition
Changes of mean muscle attenuation (MA) at the level of L3 in CT
Full Information
NCT ID
NCT03605147
First Posted
July 22, 2018
Last Updated
September 25, 2018
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03605147
Brief Title
The Effect of Calcium β-hydroxy-β-methylbutyrate (CaHMB) Supplementation in Sarcopenia in Liver Cirrhosis
Acronym
CaHMB
Official Title
The Effect of Calcium β-hydroxy-β-methylbutyrate Supplementation in Sarcopenia in Liver Cirrhosis：A Randomized Double-blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Cirrhosis, Liver
Keywords
HMB, sarcopenia, liver cirrhosis, chronic liver disease, malnutrition, muscle wasting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CaHMB
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
CaHMB
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in skeletal muscle mass
Description
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)
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Changes in total body weight
Description
Change of total body weight .
Time Frame
Baseline and 12 weeks
Title
Grip strength
Description
Changes of grip strength of both hands measured with a grip dynamometer
Time Frame
Baseline and 12 weeks
Title
Protein metabolic markers
Description
Changes of protein metabolic makers
Time Frame
Baseline and 12 weeks
Title
Changes in intramuscular fat deposition
Description
Changes of mean muscle attenuation (MA) at the level of L3 in CT
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Zhou, doctor
Phone
86 18221868695
Email
zhouji_fudan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyao Chen, doctor
Phone
86 13601767310
Email
syaochen@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, doctor
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Zhou, doctor
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Calcium β-hydroxy-β-methylbutyrate (CaHMB) Supplementation in Sarcopenia in Liver Cirrhosis
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