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

Protein Deficiency Clinical Trial

— PDCAAS  

Official title:

Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01399333
• Other study ID #: 10003
• Status: Recruiting
• Phase: Phase 4
• First received: July 19, 2011
• Last updated: July 22, 2011
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: July 2011
• Source: Southeast Bariatrics, PA
• Contact: Mary Sha Miller, RN, CBN
• Phone: 704-347-4144
• Email: mmiller[@]novanthealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Protein Deficiency

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Southeast Bariatrics	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Southeast Bariatrics, PA	University of North Carolina, Charlotte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein Absorption	protein stores and protein absorption per lab results collected at required visits	4 weeks	No
Secondary	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	No
Secondary	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	No