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

NCT ID: NCT01837238

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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

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

Keywords

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hemodialysis physical function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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beta-hydroxy beta-methylbutyrate

Calcium-HMB (3g) will be consumed daily for 6 months by all participants assigned to the HMB group.

Group Type EXPERIMENTAL

HMB

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo

The placebo group will consume non-nutritive placebo pills daily for 6 months.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

The placebo group will consume non-nutritive placebo pills daily for 6 months.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

placebo

The placebo group will consume non-nutritive placebo pills daily for 6 months.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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beta-hydroxy-beta-methylbutyrate, calcium-hmb

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Wilund, PhD

Role: PRINCIPAL_INVESTIGATOR

Kinesiology & Community Health, UIUC

Locations

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University of Illinois

Urbana, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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Renal Reserach Institute

Identifier Type: -

Identifier Source: org_study_id