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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01837238
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Complication of Dialysis Chronic Kidney Disease Muscle Loss End Stage Renal Disease Dietary Supplement: HMB Dietary Supplement: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Efficacy of Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation in Hemodialysis Patients
Study Start Date : November 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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 Name: 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.




Primary Outcome Measures :
  1. Change in lean mass over 6 months [ Time Frame: 6 months ]
    Lean mass will be assessed via DXA at baseline and after 6 months of HMB supplementation.


Secondary Outcome Measures :
  1. Change in physical function over 6 months [ Time Frame: 6 months ]
    Physical function will be assessed via isokinetic dynamometry and shuttle walk test at baseline and after 6 months of HMB supplementation.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837238


Locations
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United States, Illinois
University of Illinois
Urbana, Illinois, United States, 61822
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
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Principal Investigator: Kenneth Wilund, PhD Kinesiology & Community Health, UIUC

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT01837238    
Other Study ID Numbers: Renal Reserach Institute
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Keywords provided by University of Illinois at Urbana-Champaign:
hemodialysis
physical function
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs