An interventional study of CaHMB and Placebo in Sarcopenia and Cirrhosis, Liver, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-27.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment
This study is to evaluate the effect of CaHMB in the treatment of sarcopenia in liver cirrhosis.
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 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.
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.
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)
Time frame: Baseline and 12 weeks
Changes in total body weight
Change of total body weight .
Time frame: Baseline and 12 weeks
Grip strength
Changes of grip strength of both hands measured with a grip dynamometer
Time frame: Baseline and 12 weeks
Protein metabolic markers
Changes of protein metabolic makers
Time frame: Baseline and 12 weeks
Changes in intramuscular fat deposition
Changes of mean muscle attenuation (MA) at the level of L3 in CT
Time frame: Baseline and 12 weeks
Plan to share: No
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital