Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Southeast Bariatrics, PA.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of North Carolina, Charlotte
Information provided by:
Southeast Bariatrics, PA
ClinicalTrials.gov Identifier:
NCT01399333
First received: July 19, 2011
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Protein Deficiency
Dietary Supplement: Group 1 Meal Replacement
Dietary Supplement: Group 2 Protein Supplement
Dietary Supplement: Group 3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient

Resource links provided by NLM:


Further study details as provided by Southeast Bariatrics, PA:

Primary Outcome Measures:
  • Protein Absorption [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    protein stores and protein absorption per lab results collected at required visits


Secondary Outcome Measures:
  • Patient Compliance with Protein Supplement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
full liquid diet utilizing meal replacements with PDCAAS of 1.0
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
Active Comparator: Group 2
full liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99
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
Active Comparator: Group 3
full liquid diet utilizing protein supplement with a PDCAAS less than 0.5
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399333

Contacts
Contact: Mary Sha Miller, RN, CBN 704-347-4144 ext 216 mmiller@novanthealth.org
Contact: Mary C Head, ANP 704-347-4144 ext 220 mchead@novanthealth.org

Locations
United States, North Carolina
Southeast Bariatrics Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Mary Sha Miller, RN, CBN    704-347-4144 ext 216    mmiller@novanthealth.org   
Contact: Mary C Head, ANP    704-347-4144 ext 220    mchead@novanthealth.org   
Principal Investigator: David C Voellinger, MD         
Sponsors and Collaborators
Southeast Bariatrics, PA
University of North Carolina, Charlotte
Investigators
Principal Investigator: David C Voellinger, MD Southeast Bariatrics
  More Information

No publications provided

Responsible Party: David C. Voellinger, MD, Southeast Bariatrics, an affiliate of Novant Medical Group
ClinicalTrials.gov Identifier: NCT01399333     History of Changes
Other Study ID Numbers: 10003
Study First Received: July 19, 2011
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Southeast Bariatrics, PA:
PDCAAS
Bariatric patient

Additional relevant MeSH terms:
Protein Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 25, 2014