Complication of Dialysis, Chronic Kidney Disease, Muscle Loss, End Stage Renal Disease
Conditions
Keywords
hemodialysis, physical function
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTHMB
Following this initial round of testing,participant will be assigned to daily HMB supplementation for 6 months. You will be asked to consume a 1000mg HMB capsule 3 times per day, 7 days per week, for 6 months.
DIETARY_SUPPLEMENTplacebo
The placebo group will consume non-nutritive placebo pills daily for 6 months.
Sponsors
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Must be receiving hemodialysis treatment. * Must be willing to be randomized to HMB or placebo for 6 months * Must receive physician clearance to participate
Exclusion criteria
* Bodyweight \> 350 lbs * Currently taking an HMB supplement or HMB containing products (eg. Ensure)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lean mass over 6 months | 6 months | Lean mass will be assessed via DXA at baseline and after 6 months of HMB supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical function over 6 months | 6 months | Physical function will be assessed via isokinetic dynamometry and shuttle walk test at baseline and after 6 months of HMB supplementation. |
Countries
United States
Outcome results
None listed