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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502372

Enrollment

Registered

2007-07-17

Start date

2008-12-31

Completion date

2010-01-31

Last updated

2015-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcers

Brief 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

Interventions

DIETARY_SUPPLEMENTNutritional Supplement/Amino acids and HMB

Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement

DIETARY_SUPPLEMENTJuven

comparison of Juven with arginine only product in wound healing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PUSH tool score	8 weeks or healing completed	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026