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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Chronic Kidney Disease; Muscle Loss; Complication of Dialysis
• Intervention / Treatment: Dietary supplement: HMB; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61822
      • University of Illinois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: beta-hydroxy beta-methylbutyrate; Calcium-HMB (3g) will be consumed daily for 6 months by all participants assigned to the HMB group.	Dietary supplement: HMB; 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.; Other Names: beta-hydroxy-beta-methylbutyrate, calcium-hmb
Placebo Comparator: Placebo; The placebo group will consume non-nutritive placebo pills daily for 6 months.	Dietary supplement: placebo; The placebo group will consume non-nutritive placebo pills daily for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lean mass over 6 months	Lean mass will be assessed via DXA at baseline and after 6 months of HMB supplementation.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical function over 6 months	Physical function will be assessed via isokinetic dynamometry and shuttle walk test at baseline and after 6 months of HMB supplementation.	6 months

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Kenneth Wilund, PhD, Kinesiology & Community Health, UIUC

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: April 22, 2013
• First Posted (Estimate): April 23, 2013

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: hemodialysis; physical function
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: Renal Reserach Institute