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

NCT01837238 | Completed DMC

• 1 other identifier: Renal Reserach Institute
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

hemodialysis; physical function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in physical function over 6 months

  6 months

Study Arms (2)

beta-hydroxy beta-methylbutyrate

EXPERIMENTAL

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

Dietary Supplement: HMB

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

HMB 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.

Also known as: beta-hydroxy-beta-methylbutyrate, calcium-hmb

beta-hydroxy beta-methylbutyrate

placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be receiving hemodialysis treatment.
• Must be willing to be randomized to HMB or placebo for 6 months
• Must receive physician clearance to participate

You may not qualify if:

• Bodyweight \> 350 lbs
• Currently taking an HMB supplement or HMB containing products (eg. Ensure)

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois

Urbana, Illinois, 61822, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Muscular Atrophy; Kidney Failure, Chronic

Interventions

beta-hydroxyisovaleric acid

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Kenneth Wilund, PhD

  Kinesiology & Community Health, UIUC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: April 23, 2013
• Study Start: November 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

US (1)