Protein Deficiency
Conditions
Keywords
PDCAAS, Bariatric patient
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.
Interventions
DIETARY_SUPPLEMENTGroup 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
DIETARY_SUPPLEMENTGroup 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
DIETARY_SUPPLEMENTGroup 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
Sponsors
University of North Carolina, Charlotte
Southeast Bariatrics, PA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protein Absorption | 4 weeks | protein stores and protein absorption per lab results collected at required visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactMary Sha Miller, RN, CBN
Backup ContactMary C Head, ANP
Outcome results
None listed