Status:
UNKNOWN
Comparison of Meal Replacements Versus Protein Supplements and Utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) Method
Lead Sponsor:
Southeast Bariatrics, PA
Collaborating Sponsors:
University of North Carolina, Charlotte
Conditions:
Protein Deficiency
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
Detailed Description
The PDCAAS has been adopted by the Food and Agricultural Organization (FAO) of the World Health Organization (WHO) and is currently recognized as the standard method to evaluate protein quality. This ...
Eligibility Criteria
Inclusion
- Persons that are scheduled to undergo the adjustable gastric banding (AGB) surgery utilizing the AP Lap-Band System.
- Not having any medical confounding factors as described in exclusion criteria.
- Willing to comply with food and exercise logs and comply with the full-liquid diet, both pre-and-post-operatively.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01399333
Start Date
January 1 2010
End Date
January 1 2012
Last Update
July 26 2011
Active Locations (1)
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1
Southeast Bariatrics
Charlotte, North Carolina, United States, 28207