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

Primary Purpose

Protein Deficiency

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Group 1 Meal Replacement
Group 2 Protein Supplement
Group 3
Sponsored by
Southeast Bariatrics, PA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Protein Deficiency focused on measuring PDCAAS, Bariatric patient

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Southeast BariatricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

full liquid diet utilizing meal replacements with PDCAAS of 1.0

full liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99

full liquid diet utilizing protein supplement with a PDCAAS less than 0.5

Outcomes

Primary Outcome Measures

Protein Absorption
protein stores and protein absorption per lab results collected at required visits

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 19, 2011
Last Updated
July 22, 2011
Sponsor
Southeast Bariatrics, PA
Collaborators
University of North Carolina, Charlotte
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1. Study Identification

Unique Protocol Identification Number
NCT01399333
Brief Title
Comparison of Meal Replacements Versus Protein Supplements and Utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) Method
Acronym
PDCAAS
Official Title
Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Southeast Bariatrics, PA
Collaborators
University of North Carolina, Charlotte

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein Deficiency
Keywords
PDCAAS, Bariatric patient

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
full liquid diet utilizing meal replacements with PDCAAS of 1.0
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
full liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
full liquid diet utilizing protein supplement with a PDCAAS less than 0.5
Intervention Type
Dietary Supplement
Intervention Name(s)
Group 1 Meal Replacement
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Group 2 Protein Supplement
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Group 3
Intervention Description
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
Primary Outcome Measure Information:
Title
Protein Absorption
Description
protein stores and protein absorption per lab results collected at required visits
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Patient Compliance with Protein Supplement
Description
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.
Time Frame
4 weeks
Title
Patient tolerability and satisfaction of protein supplement
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Sha Miller, RN, CBN
Phone
704-347-4144
Ext
216
Email
mmiller@novanthealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mary C Head, ANP
Phone
704-347-4144
Ext
220
Email
mchead@novanthealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Voellinger, MD
Organizational Affiliation
Southeast Bariatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast Bariatrics
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Sha Miller, RN, CBN
Phone
704-347-4144
Ext
216
Email
mmiller@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Mary C Head, ANP
Phone
704-347-4144
Ext
220
Email
mchead@novanthealth.org
First Name & Middle Initial & Last Name & Degree
David C Voellinger, MD

12. IPD Sharing Statement

Learn more about this trial

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

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