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

NCT03605147 | Unknown

• 1 other identifier: CIR-CAHMB-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sarcopenia; Cirrhosis, Liver

Keywords

HMB; sarcopenia; liver cirrhosis; chronic liver disease; malnutrition; muscle wasting

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline and 12 weeks

Secondary Outcomes (4)

• Changes in total body weight

  Baseline and 12 weeks

• Grip strength

  Baseline and 12 weeks

• Protein metabolic markers

  Baseline and 12 weeks

• Changes in intramuscular fat deposition

  Baseline and 12 weeks

Study Arms (2)

CaHMB

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

CaHMB DIETARY_SUPPLEMENT

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.

CaHMB

Placebo DIETARY_SUPPLEMENT

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.

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (11)

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  PMID: 21199524 BACKGROUND

• Holecek M. Beta-hydroxy-beta-methylbutyrate supplementation and skeletal muscle in healthy and muscle-wasting conditions. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):529-541. doi: 10.1002/jcsm.12208. Epub 2017 May 10.

  PMID: 28493406 BACKGROUND

• Sinclair M, Gow PJ, Grossmann M, Angus PW. Review article: sarcopenia in cirrhosis--aetiology, implications and potential therapeutic interventions. Aliment Pharmacol Ther. 2016 Apr;43(7):765-77. doi: 10.1111/apt.13549. Epub 2016 Feb 5.

  PMID: 26847265 BACKGROUND

• Baumgartner RN, Koehler KM, Gallagher D, Romero L, Heymsfield SB, Ross RR, Garry PJ, Lindeman RD. Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidemiol. 1998 Apr 15;147(8):755-63. doi: 10.1093/oxfordjournals.aje.a009520.

  PMID: 9554417 BACKGROUND

• Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

  PMID: 20392703 BACKGROUND

• Tsien C, Davuluri G, Singh D, Allawy A, Ten Have GA, Thapaliya S, Schulze JM, Barnes D, McCullough AJ, Engelen MP, Deutz NE, Dasarathy S. Metabolic and molecular responses to leucine-enriched branched chain amino acid supplementation in the skeletal muscle of alcoholic cirrhosis. Hepatology. 2015 Jun;61(6):2018-29. doi: 10.1002/hep.27717. Epub 2015 Feb 27.

  PMID: 25613922 BACKGROUND

• Wilkinson DJ, Hossain T, Limb MC, Phillips BE, Lund J, Williams JP, Brook MS, Cegielski J, Philp A, Ashcroft S, Rathmacher JA, Szewczyk NJ, Smith K, Atherton PJ. Impact of the calcium form of beta-hydroxy-beta-methylbutyrate upon human skeletal muscle protein metabolism. Clin Nutr. 2018 Dec;37(6 Pt A):2068-2075. doi: 10.1016/j.clnu.2017.09.024. Epub 2017 Oct 6.

  PMID: 29097038 BACKGROUND

• Tsien CD, McCullough AJ, Dasarathy S. Late evening snack: exploiting a period of anabolic opportunity in cirrhosis. J Gastroenterol Hepatol. 2012 Mar;27(3):430-41. doi: 10.1111/j.1440-1746.2011.06951.x.

  PMID: 22004479 BACKGROUND

• Takaguchi K, Moriwaki H, Doyama H, Iida M, Yagura M, Shimada N, Kang M, Yamada H, Kumada H. Effects of branched-chain amino acid granules on serum albumin level and prognosis are dependent on treatment adherence in patients with liver cirrhosis. Hepatol Res. 2013 May;43(5):459-66. doi: 10.1111/j.1872-034X.2012.01097.x. Epub 2012 Oct 10.

  PMID: 23046471 BACKGROUND

• Plank LD, Gane EJ, Peng S, Muthu C, Mathur S, Gillanders L, McIlroy K, Donaghy AJ, McCall JL. Nocturnal nutritional supplementation improves total body protein status of patients with liver cirrhosis: a randomized 12-month trial. Hepatology. 2008 Aug;48(2):557-66. doi: 10.1002/hep.22367.

  PMID: 18627001 BACKGROUND

• Nishikawa H, Shiraki M, Hiramatsu A, Moriya K, Hino K, Nishiguchi S. Japan Society of Hepatology guidelines for sarcopenia in liver disease (1st edition): Recommendation from the working group for creation of sarcopenia assessment criteria. Hepatol Res. 2016 Sep;46(10):951-63. doi: 10.1111/hepr.12774.

  PMID: 27481650 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Liver Cirrhosis; Malnutrition; Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Shiyao Chen, doctor

  Fudan University

  STUDY CHAIR

Central Study Contacts

Ji Zhou, doctor

CONTACT

86 18221868695; zhouji_fudan@163.com

Shiyao Chen, doctor

CONTACT

86 13601767310; syaochen@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2018
• First Posted: July 30, 2018
• Study Start: August 22, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)