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

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ClinicalTrials.gov Identifier: NCT03605147
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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

Condition or disease Intervention/treatment Phase
Sarcopenia Cirrhosis, Liver Dietary Supplement: CaHMB Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Calcium β-hydroxy-β-methylbutyrate Supplementation in Sarcopenia in Liver Cirrhosis:A Randomized Double-blind Controlled Trial
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Cirrhosis

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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Changes in total body weight [ Time Frame: Baseline and 12 weeks ]
    Change of total body weight .

  2. Grip strength [ Time Frame: Baseline and 12 weeks ]
    Changes of grip strength of both hands measured with a grip dynamometer

  3. Protein metabolic markers [ Time Frame: Baseline and 12 weeks ]
    Changes of protein metabolic makers

  4. Changes in intramuscular fat deposition [ Time Frame: Baseline and 12 weeks ]
    Changes of mean muscle attenuation (MA) at the level of L3 in CT



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605147


Contacts
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Contact: Ji Zhou, doctor 86 18221868695 zhouji_fudan@163.com
Contact: Shiyao Chen, doctor 86 13601767310 syaochen@163.com

Locations
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China, Shanghai
Shanghai Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ji Zhou, doctor         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Shiyao Chen, doctor Fudan University

Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03605147     History of Changes
Other Study ID Numbers: CIR-CAHMB-001
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Zhongshan Hospital:
HMB
sarcopenia
liver cirrhosis
chronic liver disease
malnutrition
muscle wasting

Additional relevant MeSH terms:
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Liver Cirrhosis
Sarcopenia
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents