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

NCT00502372 | Terminated Phase 1 DMC

• 1 other identifier: BJ93
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Pressure Ulcers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Enriched product, dietary supplement

EXPERIMENTAL

Subjects receiving enriched product compared to an unenriched product

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

1

ACTIVE COMPARATOR

Subjects not receiving enriched product

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

Interventions

Nutritional Supplement/Amino acids and HMB DIETARY_SUPPLEMENT

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

Also known as: Juven, Argenaid

1; Enriched product, dietary supplement

Juven DIETARY_SUPPLEMENT

comparison of Juven with arginine only product in wound healing

Also known as: Argenaid

1; Enriched product, dietary supplement

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Arkansas Veterans Healthcare System: lead
• Abbott: collaborator

Study Sites (1)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Dietary Supplements; Amino Acids

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Amino Acids, Peptides, and Proteins

Study Officials

• Cathey Powers, MD

  Central Arkansas VA/UAMS College of Medicine

  PRINCIPAL INVESTIGATOR

• Ronni Chernoff, PhD

  Central Arkansas VA/UAMS College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 17, 2007
• Study Start: December 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

US (1)