Comparison of Meal Replacements Versus Protein Supplements and Utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) Method
This study is currently recruiting participants.
Verified July 2011 by Southeast Bariatrics, PA
Sponsor:
Southeast Bariatrics, PA
Collaborator:
University of North Carolina, Charlotte
Information provided by:
Southeast Bariatrics, PA
ClinicalTrials.gov Identifier:
NCT01399333
First received: July 19, 2011
Last updated: July 22, 2011
Last verified: July 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Protein Deficiency |
Dietary Supplement: Group 1 Meal Replacement Dietary Supplement: Group 2 Protein Supplement Dietary Supplement: Group 3 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Screening |
| Official Title: | Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient |
Resource links provided by NLM:
Further study details as provided by Southeast Bariatrics, PA:
Primary Outcome Measures:
- Protein Absorption [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]protein stores and protein absorption per lab results collected at required visits
Secondary Outcome Measures:
- Patient Compliance with Protein Supplement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399333
Contacts
| Contact: Mary Sha Miller, RN, CBN | 704-347-4144 ext 216 | mmiller@novanthealth.org |
| Contact: Mary C Head, ANP | 704-347-4144 ext 220 | mchead@novanthealth.org |
Locations
| United States, North Carolina | |
| Southeast Bariatrics | Recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| Contact: Mary Sha Miller, RN, CBN 704-347-4144 ext 216 mmiller@novanthealth.org | |
| Contact: Mary C Head, ANP 704-347-4144 ext 220 mchead@novanthealth.org | |
| Principal Investigator: David C Voellinger, MD | |
Sponsors and Collaborators
Southeast Bariatrics, PA
University of North Carolina, Charlotte
Investigators
| Principal Investigator: | David C Voellinger, MD | Southeast Bariatrics |
More Information
No publications provided
| Responsible Party: | David C. Voellinger, MD, Southeast Bariatrics, an affiliate of Novant Medical Group |
| ClinicalTrials.gov Identifier: | NCT01399333 History of Changes |
| Other Study ID Numbers: | 10003 |
| Study First Received: | July 19, 2011 |
| Last Updated: | July 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Southeast Bariatrics, PA:
|
PDCAAS Bariatric patient |
Additional relevant MeSH terms:
|
Protein Deficiency Deficiency Diseases Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on June 18, 2013