Clinical Trials Directory

Trials / Completed

CompletedNCT01837238

Efficacy of Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation in Hemodialysis Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
41 (actual)
Sponsor
University of Illinois at Urbana-Champaign · Academic / Other
Sex
All
Age
30 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTHMBFollowing 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_SUPPLEMENTplaceboThe placebo group will consume non-nutritive placebo pills daily for 6 months.

Timeline

Start date
2012-11-01
Primary completion
2016-05-01
Completion
2016-05-01
First posted
2013-04-23
Last updated
2016-10-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01837238. Inclusion in this directory is not an endorsement.