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

U

University of Illinois at Urbana-Champaign

Status

Completed

Conditions

Chronic Kidney Disease
Complication of Dialysis
End Stage Renal Disease
Muscle Loss

Treatments

Dietary Supplement: HMB
Dietary Supplement: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01837238
Renal Reserach Institute

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

41 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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