Comparison of Meal Replacements Versus Protein Supplements and Utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) Method
NCT ID: NCT01399333
Last Updated: 2011-07-26
Study Results
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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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2010-01-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Group 1
full liquid diet utilizing meal replacements with PDCAAS of 1.0
Group 1 Meal Replacement
4 weeks of utilizing Group 1 Meal Replacement 3-4 times daily, supplementing this protein product at each meal. As standard of care for the bariatric patient, they are required to get in 60-80 gms of protein daily
Group 2
full liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99
Group 2 Protein Supplement
4 weeks of utilizing Group 2 protein supplement 3-4 times daily, replacing this protein product at each meal. As standard of care for the bariatric patient, they are required to get in 60-80 gms of protein daily
Group 3
full liquid diet utilizing protein supplement with a PDCAAS less than 0.5
Group 3
4 weeks of utilizing Group 3 protein supplement 3-4 times daily, replacing this protein product at each meal. As standard of care for the bariatric patient, they are required to get in 60-80 gms of protein daily
Interventions
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Group 1 Meal Replacement
4 weeks of utilizing Group 1 Meal Replacement 3-4 times daily, supplementing this protein product at each meal. As standard of care for the bariatric patient, they are required to get in 60-80 gms of protein daily
Group 2 Protein Supplement
4 weeks of utilizing Group 2 protein supplement 3-4 times daily, replacing this protein product at each meal. As standard of care for the bariatric patient, they are required to get in 60-80 gms of protein daily
Group 3
4 weeks of utilizing Group 3 protein supplement 3-4 times daily, replacing this protein product at each meal. As standard of care for the bariatric patient, they are required to get in 60-80 gms of protein daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Persons who are not undergoing AGB surgery or are unwilling to comply with study methods or are medically not eligible.
* Taking diuretics
* Have been diagnosed with unstable diabetes, unstable neurologic conditions, unstable cardiac conditions or gastro-intestinal disorders, renal dysfunction, wounds, and autoimmune disorders that may increase protein needs.
* Uncontrolled gastrointestinal disease, such as Crohn's disease, diverticulitis, Celiac disease, or ulcerative colitis.
* Active malignancy
* Patients will also be excluded if pre-operative vitamin deficiencies are not corrected by surgery.
18 Years
65 Years
ALL
Yes
Sponsors
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University of North Carolina, Charlotte
OTHER
Southeast Bariatrics, PA
OTHER
Responsible Party
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Southeast Bariatrics, an affiliate of Novant Medical Group
Principal Investigators
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David C Voellinger, MD
Role: PRINCIPAL_INVESTIGATOR
Southeast Bariatrics
Locations
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Southeast Bariatrics
Charlotte, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10003
Identifier Type: -
Identifier Source: org_study_id
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