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

Phase 4

• Conditions: Protein Deficiency
• Interventions: Dietary Supplement: Group 1 Meal Replacement; Dietary Supplement: Group 2 Protein Supplement; Dietary Supplement: Group 3

• Registration Number: NCT01399333
• Lead Sponsor: Southeast Bariatrics, PA

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 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 Timeline

• Study Start: 2010-01
• Status Verified: 2011-07
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-21
• Last Update Submitted: 2011-07-22
• Last Update Posted: 2011-07-26
• Primary Completion: 2011-08
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Group 1 Meal Replacement	full liquid diet utilizing meal replacements with PDCAAS of 1.0
Group 2	Group 2 Protein Supplement	full liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99
Group 3	Group 3	full liquid diet utilizing protein supplement with a PDCAAS less than 0.5

Primary Outcome Measures

Name	Time	Method
Protein Absorption	4 weeks	protein stores and protein absorption per lab results collected at required visits

Secondary Outcome Measures

Name	Time	Method
Patient Compliance with Protein Supplement	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	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.

Trial Locations

Locations (1)

Southeast Bariatrics; 🇺🇸 Charlotte, North Carolina, United States