Protein DeficiencyPhase 4PDCAASNCT01399333
Comparison of Meal Replacements Versus Protein Supplements and Utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) Method
A Phase 4 study testing Group 1 Meal Replacement, Group 2 Protein Supplement and Group 3 in people with Protein Deficiency, run by Southeast Bariatrics, PA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Deficiency
- What is being tested?
- Group 1 Meal Replacement, Group 2 Protein Supplement and Group 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southeast Bariatrics
Charlotte, North Carolina, 28207
Mary Sha Miller, RN, CBN, 704-347-4144 ext. 216, mmiller@novanthealth.org
Mary C Head, ANP, 704-347-4144 ext. 220, mchead@novanthealth.org
About this study
Official title: Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient
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.
Read the 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.
- Conditions
- Protein Deficiency
- Being tested
- Group 1 Meal Replacement, Group 2 Protein Supplement, Group 3
- Keywords
- PDCAAS, Bariatric patient
- Medical subject headings
- Protein Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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 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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | full liquid diet utilizing meal replacements with PDCAAS of 1.0 Receives: Dietary Supplement: Group 1 Meal Replacement |
| Group 2 | Active comparator | full liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99 Receives: Dietary Supplement: Group 2 Protein Supplement |
| Group 3 | Active comparator | full liquid diet utilizing protein supplement with a PDCAAS less than 0.5 Receives: Dietary Supplement: Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Absorption
protein stores and protein absorption per lab results collected at required visits
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionAug 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast Bariatrics, PA
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Charlotte
- Investigators
- David C Voellinger, MD, Principal investigator, Southeast Bariatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399333
- Sponsor's protocol ID
- 10003
- Acronym
- PDCAAS
- Status last verified
- Jul 2011
- First submitted
- 19 Jul 2011
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient
- ClinicalTrials.gov ID
- NCT01399333
- Acronym / sponsor ID
- PDCAAS / 10003
- Conditions
- Protein Deficiency
- Keywords
- PDCAAS, Bariatric patient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southeast Bariatrics, PAUniversity, hospital or other
- Collaborators
- University of North Carolina, Charlotte
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Dietary Supplement: Group 1 Meal Replacementfull liquid diet utilizing meal replacements with PDCAAS of 1.0 |
| Group 2 | Active comparator | Dietary Supplement: Group 2 Protein Supplementfull liquid diet utilizing protein supplements with PDCAAS of 0.5-0.99 |
| Group 3 | Active comparator | Dietary Supplement: Group 3full liquid diet utilizing protein supplement with a PDCAAS less than 0.5 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 Meal Replacement4 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 | Dietary supplement | Group 1 |
| Group 2 Protein Supplement4 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 | Dietary supplement | Group 2 |
| Group 34 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 | Dietary supplement | Group 3 |
Primary outcome
Protein Absorption
Time frame: 4 weeks
protein stores and protein absorption per lab results collected at required visits
2 secondary outcomes
Patient Compliance with Protein Supplement
Time frame: 4 weeks
Patient tolerability and satisfaction of protein supplement
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Voellinger, MD principal investigator
Southeast Bariatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group 1 Meal Replacement, Group 2 Protein Supplement and Group 3 in people with Protein Deficiency, run by Southeast Bariatrics, PA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Sha Miller, RN, CBN (704-347-4144 ext. 216, mmiller@novanthealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein Absorption (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.