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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Complication of Dialysis; Muscle Loss; End Stage Renal Disease
• Interventions: Dietary Supplement: placebo; Dietary Supplement: HMB

• Registration Number: NCT01837238
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-23
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	The placebo group will consume non-nutritive placebo pills daily for 6 months.
beta-hydroxy beta-methylbutyrate	HMB	Calcium-HMB (3g) will be consumed daily for 6 months by all participants assigned to the HMB group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Illinois; 🇺🇸 Urbana, Illinois, United States