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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Dietary Supplement: Nutritional Supplement/Amino acids and HMB
* Dietary Supplement: Juven


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Stage II pressure ulcer or greater Patients who consent to participate Patients who can ingest the supplement either orally or per feeding tube Patients who are 21 years of age or older Exclusion Criteria: 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 bolus tube feedings

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |