Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB)

Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate

The focus of this study is to look at the role of nutrition in the healing of pressure ulcers. The purpose of this study is to test whether the rate of healing of pressure ulcers is increased in those patients receiving a nutritional supplement of amino acids and the leucine metabolite, B-hydroxy-B-methylbutyrate is enhanced when compared to control patients receiving a supplement containing only one of the proteins in the experimental supplement

Study Overview

• Status: Terminated
• Conditions: Pressure Ulcers
• Intervention / Treatment: Dietary supplement: Nutritional Supplement/Amino acids and HMB; Dietary supplement: Juven

Detailed Description

Patients who have pressure ulcers Stage II or greater will be randomized to receiving one of two nutritional supplements. One supplement contains arginine and the other contains both arginine,glutamine and leucine metabolites. Pressure ulcers will be measured at study entry and measured biweekly using a standardized tool (PUSH) until the trial is completed or the pressure ulcer has healed.

Inclusion criteria include:

• Stage II or greater pressure ulcer
• Patient consent
• Patients who can drink supplement or receive it by tube
• Patients who are 21 years old or greater

Exclusion criteria include:

• Patients with infected wounds
• Patients with cellulitis, sepsis or osteomyelitis
• Patients with end-organ failure
• Patients with poorly controlled diabetes mellitus (HbA1C>10)
• Patients who cannot tolerate oral or tube feeding

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Central Arkansas Veterans Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with Stage II pressure ulcer or greater
2. Patients who consent to participate
3. Patients who can ingest the supplement either orally or per feeding tube
4. Patients who are 21 years of age or older

Exclusion Criteria:

1. Patients with infected wounds
2. Patients with cellulitis, sepsis or osteomyelitis
3. Patients with end-organ failure
4. Patients with poorly controlled diabetes mellitus (HbA1C>10)
5. Patients who cannot tolerate oral or bolus tube feedings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enriched product, dietary supplement; Subjects receiving enriched product compared to an unenriched product	Dietary supplement: Nutritional Supplement/Amino acids and HMB; Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement; Other Names: Juven; Argenaid; Dietary supplement: Juven; comparison of Juven with arginine only product in wound healing; Other Names: Argenaid
Active Comparator: 1; Subjects not receiving enriched product	Dietary supplement: Nutritional Supplement/Amino acids and HMB; Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement; Other Names: Juven; Argenaid; Dietary supplement: Juven; comparison of Juven with arginine only product in wound healing; Other Names: Argenaid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PUSH tool score	The PUSH tool measures the healing of a pressure ulcer by actually measuring the depth and width, in 2 dimensions, of a wound. A wound heals from the wound bed and closes from the inside to the outside if healthy pink granulation tissue can be seen. This tool contributes to the consistency of measurement of a healing wound.	8 weeks or healing completed

Collaborators and Investigators

• Sponsor: Central Arkansas Veterans Healthcare System
• Collaborators: Abbott
• Investigators: Principal Investigator: Cathey Powers, MD, Central Arkansas VA/UAMS College of Medicine; Principal Investigator: Ronni Chernoff, PhD, Central Arkansas VA/UAMS College of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: July 13, 2007
• First Submitted That Met QC Criteria: July 13, 2007
• First Posted (Estimate): July 17, 2007

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: BJ93