NCT00502372

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Central Arkansas Veterans Healthcare System · Federal
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Pressure Ulcers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional Supplement/Amino acids and HMB	Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement
DIETARY_SUPPLEMENT	Juven	comparison of Juven with arginine only product in wound healing

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-07-17
• Last updated: 2015-12-15

Locations

1 site across 1 country: United States