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| Name | Class |
|---|---|
| University of North Carolina, Charlotte | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | full liquid diet utilizing meal replacements with PDCAAS of 1.0 |
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| Group 2 | Active Comparator | full liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99 |
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| Group 3 | Active Comparator | full liquid diet utilizing protein supplement with a PDCAAS less than 0.5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 Meal Replacement | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Protein Absorption | protein stores and protein absorption per lab results collected at required visits | 4 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Sha Miller, RN, CBN | Contact | 704-347-4144 | 216 | mmiller@novanthealth.org |
| Mary C Head, ANP | Contact | 704-347-4144 | 220 | mchead@novanthealth.org |
| Name | Affiliation | Role |
|---|---|---|
| David C Voellinger, MD | Southeast Bariatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Bariatrics | Recruiting | Charlotte | North Carolina | 28207 | United States |
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| Group 2 Protein Supplement | Dietary 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 | Dietary Supplement | 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 |
|
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 |
| ID | Term |
|---|---|
| D011488 | Protein Deficiency |
| ID | Term |
|---|---|
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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