NCT01399333

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

1.6 years

First QC Date

July 19, 2011

Last Update Submit

July 22, 2011

Conditions

Protein Deficiency

Keywords

PDCAASBariatric patient

Outcome Measures

Primary Outcomes (1)

  • Protein Absorption

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

    4 weeks

Secondary Outcomes (2)

  • Patient Compliance with Protein Supplement

    4 weeks

  • Patient tolerability and satisfaction of protein supplement

    4 weeks

Study Arms (3)

Group 1

ACTIVE COMPARATOR

full liquid diet utilizing meal replacements with PDCAAS of 1.0

Dietary Supplement: Group 1 Meal Replacement

Group 2

ACTIVE COMPARATOR

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

Dietary Supplement: Group 2 Protein Supplement

Group 3

ACTIVE COMPARATOR

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

Dietary Supplement: Group 3

Interventions

Group 1 Meal ReplacementDIETARY_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

Group 1
Group 2 Protein SupplementDIETARY_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 2
Group 3DIETARY_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

Group 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons that are scheduled to undergo the adjustable gastric banding (AGB) surgery utilizing the AP Lap-Band System.

You may not qualify if:

  • Willing to comply with food and exercise logs and comply with the full-liquid diet, both pre-and-post-operatively.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast Bariatrics

Charlotte, North Carolina, 28207, United States

RECRUITING

MeSH Terms

Conditions

Protein Deficiency

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • David C Voellinger, MD

    Southeast Bariatrics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Sha Miller, RN, CBN

CONTACT

704-347-4144mmiller@novanthealth.org

Mary C Head, ANP

CONTACT

704-347-4144mchead@novanthealth.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 21, 2011

Study Start

January 1, 2010

Primary Completion

August 1, 2011

Study Completion

January 1, 2012

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

US(1)