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

Central Arkansas Veterans Healthcare System

Status and phase: Terminated; Phase 1

Conditions: Pressure Ulcers

Treatments: Dietary Supplement: Juven; Dietary Supplement: Nutritional Supplement/Amino acids and HMB

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT00502372

BJ93

Details and patient eligibility

About

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

Full 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

Enrollment: 9 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

9 participants in 2 patient groups

Enriched product, dietary supplement

Experimental group

Description:

Subjects receiving enriched product compared to an unenriched product

Treatment:

Dietary Supplement: Nutritional Supplement/Amino acids and HMB

Dietary Supplement: Juven

1

Active Comparator group

Description:

Subjects not receiving enriched product

Treatment:

Dietary Supplement: Nutritional Supplement/Amino acids and HMB

Dietary Supplement: Juven