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Meal Replacement
Group 2 for Protein Malnutrition (PDCAAS Trial)
Phase 4
Waitlist Available
Led By David C Voellinger, MD
Research Sponsored by Southeast Bariatrics, PA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
The purpose of this research study is to compare the varying qualities of protein supplements utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) method and evaluating the clinical outcome related to protein stores and absorption.
Eligible Conditions
- Protein Malnutrition
- Protein Deficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Protein Absorption
Secondary study objectives
Patient Compliance with Protein Supplement
Patient tolerability and satisfaction of protein supplement
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: Group 2Active Control1 Intervention
full liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99
Group II: Group 3Active Control1 Intervention
full liquid diet utilizing protein supplement with a PDCAAS less than 0.5
Group III: Group 1Active Control1 Intervention
full liquid diet utilizing meal replacements with PDCAAS of 1.0
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Who is running the clinical trial?
Southeast Bariatrics, PALead Sponsor
University of North Carolina, CharlotteOTHER
25 Previous Clinical Trials
11,251 Total Patients Enrolled
David C Voellinger, MDPrincipal InvestigatorSoutheast Bariatrics
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