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

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.

Study Overview

• Status: Unknown
• Conditions: Protein Deficiency
• Intervention / Treatment: Dietary supplement: Group 1 Meal Replacement; Dietary supplement: Group 2 Protein Supplement; Dietary supplement: Group 3

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mary Sha Miller, RN, CBN; Phone Number: 216 704-347-4144; Email: mmiller@novanthealth.org
• Study Contact Backup: Name: Mary C Head, ANP; Phone Number: 220 704-347-4144; Email: mchead@novanthealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Southeast Bariatrics
      • Contact: Mary Sha Miller, RN, CBN; Phone Number: 216 704-347-4144; Email: mmiller@novanthealth.org
      • Contact: Mary C Head, ANP; Phone Number: 220 704-347-4144; Email: mchead@novanthealth.org
      • Principal Investigator: David C Voellinger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein Absorption	protein stores and protein absorption per lab results collected at required visits	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Compliance with Protein Supplement	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.	4 weeks
Patient tolerability and satisfaction of protein supplement	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.	4 weeks

Collaborators and Investigators

• Sponsor: Southeast Bariatrics, PA
• Collaborators: University of North Carolina, Charlotte
• Investigators: Principal Investigator: David C Voellinger, MD, Southeast Bariatrics

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ANTICIPATED): August 1, 2011
• Study Completion (ANTICIPATED): January 1, 2012

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 20, 2011
• First Posted (ESTIMATE): July 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 26, 2011
• Last Update Submitted That Met QC Criteria: July 22, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: PDCAAS; Bariatric patient
• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Malnutrition; Protein Deficiency
• Other Study ID Numbers: 10003