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

NCT ID: NCT00502372

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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

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Pressure Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enriched product, dietary supplement

Subjects receiving enriched product compared to an unenriched product

Group Type EXPERIMENTAL

Nutritional Supplement/Amino acids and HMB

Intervention Type DIETARY_SUPPLEMENT

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

Juven

Intervention Type DIETARY_SUPPLEMENT

comparison of Juven with arginine only product in wound healing

1

Subjects not receiving enriched product

Group Type ACTIVE_COMPARATOR

Nutritional Supplement/Amino acids and HMB

Intervention Type DIETARY_SUPPLEMENT

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

Juven

Intervention Type DIETARY_SUPPLEMENT

comparison of Juven with arginine only product in wound healing

Interventions

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Nutritional Supplement/Amino acids and HMB

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

Intervention Type DIETARY_SUPPLEMENT

Juven

comparison of Juven with arginine only product in wound healing

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Juven Argenaid Argenaid

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Central Arkansas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cathey Powers, MD

Role: PRINCIPAL_INVESTIGATOR

Central Arkansas VA/UAMS College of Medicine

Ronni Chernoff, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Arkansas VA/UAMS College of Medicine

Locations

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Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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BJ93

Identifier Type: -

Identifier Source: org_study_id