Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB)
Primary Purpose
Pressure Ulcers
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nutritional Supplement/Amino acids and HMB
Juven
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcers
Eligibility Criteria
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
Sites / Locations
- Central Arkansas Veterans Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Enriched product, dietary supplement
1
Arm Description
Subjects receiving enriched product compared to an unenriched product
Subjects not receiving enriched product
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00502372
First Posted
July 13, 2007
Last Updated
December 14, 2015
Sponsor
Central Arkansas Veterans Healthcare System
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00502372
Brief Title
Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB)
Official Title
Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
VA never granted approval following suspension of enrollment.
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Arkansas Veterans Healthcare System
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enriched product, dietary supplement
Arm Type
Experimental
Arm Description
Subjects receiving enriched product compared to an unenriched product
Arm Title
1
Arm Type
Active Comparator
Arm Description
Subjects not receiving enriched product
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Supplement/Amino acids and HMB
Other Intervention Name(s)
Juven, Argenaid
Intervention Description
Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Juven
Other Intervention Name(s)
Argenaid
Intervention Description
comparison of Juven with arginine only product in wound healing
Primary Outcome Measure Information:
Title
PUSH tool score
Description
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.
Time Frame
8 weeks or healing completed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathey Powers, MD
Organizational Affiliation
Central Arkansas VA/UAMS College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronni Chernoff, PhD
Organizational Affiliation
Central Arkansas VA/UAMS College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB)
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