Clinical Trial: Comparison of Meal Replacements Versus Protein Supplements and Utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) Method

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient

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 outcome related to protein stores and absorption.

Detailed Summary: 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 study will also examine patient tolerability, satiety, and satisfaction while using meal replacements versus protein supplements. This research study looks to gain knowledge on the varying qualities of protein and find the most effective protein supplement and/or meal replacement that provides increased patient compliance and promotes a healthy recovery.
Sponsor: Southeast Bariatrics, PA

Current Primary Outcome: Protein Absorption [ Time Frame: 4 weeks ]

protein stores and protein absorption per lab results collected at required visits


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient Compliance with Protein Supplement [ Time Frame: 4 weeks ]
    Evaluate patient compliance with protein supplements during the required 4 week liquid diet phase, which include 2 weeks prior to surgery and 2 weeks after surgery.
  • Patient tolerability and satisfaction of protein supplement [ Time Frame: 4 weeks ]
    Evaluate the patient's tolerability of the protein supplement, specifically assessing GI symptoms and satiety, as well as evaluating patient perceptions of satisfaction of the product and satiety.


Original Secondary Outcome: Same as current

Information By: Southeast Bariatrics, PA

Dates:
Date Received: July 19, 2011
Date Started: January 2010
Date Completion: January 2012
Last Updated: July 22, 2011
Last Verified: July 2011