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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Protein Deficiency

Intervention / Treatment
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* Dietary Supplement: Group 1 Meal Replacement
* Dietary Supplement: Group 2 Protein Supplement
* Dietary Supplement: Group 3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>full liquid diet utilizing meal replacements with PDCAAS of 1.0 | Dietary Supplement: Group 1 Meal Replacement<br>* 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<br>|
| Active Comparator: Group 2<br>full liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99 | Dietary Supplement: Group 2 Protein Supplement<br>* 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<br>|
| Active Comparator: Group 3<br>full liquid diet utilizing protein supplement with a PDCAAS less than 0.5 | Dietary Supplement: Group 3<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDCAAS, Bariatric patient