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

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ClinicalTrials.gov Identifier: NCT01399333
Recruitment Status : Unknown
Verified July 2011 by Southeast Bariatrics, PA.
Recruitment status was:  Recruiting
First Posted : July 21, 2011
Last Update Posted : July 26, 2011
Sponsor:
Collaborator:
Information provided by:

July 19, 2011
July 21, 2011
July 26, 2011
January 2010
August 2011   (Final data collection date for primary outcome measure)
Protein Absorption [ Time Frame: 4 weeks ]
protein stores and protein absorption per lab results collected at required visits
Same as current
Complete list of historical versions of study NCT01399333 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Comparison of Meal Replacements Versus Protein Supplements and Utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) Method
Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Protein Deficiency
  • Dietary Supplement: 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
  • Dietary Supplement: 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
  • Dietary Supplement: 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
  • Active Comparator: Group 1
    full liquid diet utilizing meal replacements with PDCAAS of 1.0
    Intervention: Dietary Supplement: Group 1 Meal Replacement
  • Active Comparator: Group 2
    full liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99
    Intervention: Dietary Supplement: Group 2 Protein Supplement
  • Active Comparator: Group 3
    full liquid diet utilizing protein supplement with a PDCAAS less than 0.5
    Intervention: Dietary Supplement: Group 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
January 2012
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01399333
10003
No
Not Provided
Not Provided
David C. Voellinger, MD, Southeast Bariatrics, an affiliate of Novant Medical Group
Southeast Bariatrics, PA
University of North Carolina, Charlotte
Principal Investigator: David C Voellinger, MD Southeast Bariatrics
Southeast Bariatrics, PA
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP