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

Southeast Bariatrics, PA

Status and phase: Unknown; Phase 4

Conditions: Protein Deficiency

Treatments: Dietary Supplement: Group 3; Dietary Supplement: Group 1 Meal Replacement; Dietary Supplement: Group 2 Protein Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01399333

10003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Group 1

Active Comparator group

Description:

full liquid diet utilizing meal replacements with PDCAAS of 1.0

Treatment:

Dietary Supplement: Group 1 Meal Replacement

Group 2

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Group 2 Protein Supplement

Group 3

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Group 3