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

• Sponsor: Southeast Bariatrics, PA (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01399333
• Collaborator: University of North Carolina, Charlotte (Other)
• Enrollment: 60
• Location: 1
• Arms: 3
• Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Protein Deficiency	Dietary Supplement: Group 1 Meal Replacement; Dietary Supplement: Group 2 Protein Supplement; Dietary Supplement: Group 3	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Screening
• Official Title: Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient
• Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Aug 1, 2011
• Anticipated Study Completion Date: Jan 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Protein Absorption [4 weeks]

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

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Southeast Bariatrics	Charlotte	North Carolina	United States	28207

Sponsors and Collaborators

• Southeast Bariatrics, PA
• University of North Carolina, Charlotte

Investigators

• Principal Investigator: David C Voellinger, MD, Southeast Bariatrics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01399333
• Other Study ID Numbers: 10003
• First Posted: Jul 21, 2011
• Last Update Posted: Jul 26, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: PDCAAS; Bariatric patient
• Additional relevant MeSH terms: Protein Deficiency

Study Results

No Results Posted as of Jul 26, 2011