Chronic Kidney Disease Clinical Trial
Official title:
Efficacy of Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation in Hemodialysis Patients
The purpose of this study is to examine the effect of 6 months of daily beta-hydroxy beta-methylbutyrate (HMB) supplementation on the physical function and the health of bones, arteries and heart in hemodialysis patients.
Patients with renal failure receiving hemodialysis experience an increased rate of skeletal
muscle protein catabolism which is associated with a number of co-morbid conditions
including declines in muscle mass and strength, significantly increased fall risk, and
reduced quality of life (QOL. Therefore, interventions to prevent muscle loss in
hemodialysis are needed. Pharmacological agents have been investigated to treat muscle loss
in dialysis patients; however, many of these treatments are expensive and have undesirable
side effects. As a result, low-cost interventions designed to attenuate losses in muscle
mass and strength in hemodialysis patients are needed.
Beta-hydroxy beta-methylbutyrate (HMB) represents a potential low-cost nutritional
intervention to attenuate muscle loss in hemodialysis patients. HMB is a metabolite of the
amino acid leucine that has been shown to safely increase muscle mass in other clinical
populations with prevalent muscle loss, such as the elderly, cancer, and AIDS patients
primarily through reductions in skeletal muscle protein catabolism. The primary purpose of
the trial is to determine if oral supplementation with HMB attenuates muscle loss, improves
muscle strength, physical function, fall risk and QOL in hemodialysis patients. Alterations
in protein and gene expression associated with skeletal muscle protein turnover will be
measured to investigate the mechanism for changes in our primary outcomes. We hypothesize
that HMB supplementation will attenuate declines in muscle size and strength in hemodialysis
patients.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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