Study to Compare Milk Protein Isolate (MPI) With Caseinate in Terms of Protein Utilization

A Randomised, Double-blinded Study to Compare Milk Protein Isolate (MPI)With Caseinate in Terms of Protein Utilization in Healthy Elderly Subjects

The Clinical Research Ethics Committee, Cork comprises of faculty representatives, external representatives, legal representatives and appropriate individuals and ex-officio administrative members with needed expertise. Ethics Committee members, including the Chair, are appointed by the Head of College, University College Cork, Medical School.

The Ethics Committee meets once a month.

Study Overview

• Status: Completed
• Conditions: Enteral Feeds
• Intervention / Treatment: Dietary supplement: Milk Protein Isolate; Dietary supplement: Caseinate

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • University College Cork

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

To be considered eligible for enrolment into the study, subjects must;

1. Be able to give written informed consent.
2. Be between 65 and 75 years of age.
3. Be in generally good health as determined by the investigator.
4. Have no evidence of gastrointestinal disease or of a functional gastrointestinal disorder as determined by the Bowel Disease Questionnaire.
5. Have a stable body weight over the past 3-months.
6. Have a Body Mass Index (BMI) greater than 22, for males and 20 for females and less than 30.
7. Have a satisfactory nutritional status.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the below criteria;

1. Are less than 65 and greater than 75 years of age.
2. Have evidence of gastrointestinal disease or other functional gastrointestinal disorder as determined by the Bowel Disease Questionnaire.
3. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic or any condition which contraindicates, in the investigators judgement, entry to the study).
4. Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include anti-inflammatory drugs, corticosteroids, laxatives, enemas, antibiotics (within 1 month), anti-coagulants, and over-the counter non-steroidal analgesics. Subjects should have a wash-out period of two-weeks.
5. Be a smoker.
6. Consume more than the recommended alcohol guidelines i.e. 3-4 alcohol units a day for a man and for a woman 2-3 units a day.
7. Suffer from psychiatric disease
8. Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or recent unexplained bleeding.
9. Have dietary habits (slimming or vegetarian diet) which could interfere with the assessment of the study product.
10. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
11. Subjects may not be receiving treatment involving experimental drugs.
12. If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
13. Have a malignant disease or any concomitant end-stage organ disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Milk protein isolate; The test meal is a vanilla flavoured enteral drink, containing 1.5kcal/ml, 21% CHO, 6% protein and 5% fat. The 6% protein in this test meal is Milk Protein Isolate.	Dietary supplement: Milk Protein Isolate; The test meal is a vanilla flavoured enteral drink, containing 1.5kcal/ml, 21% CHO, 6% protein and 5% fat. The 6% protein in this test meal is Milk Protein Isolate.
ACTIVE_COMPARATOR: Caseinate; The test meal is a vanilla flavoured enteral drink, containing 1.5kcal/ml, 21% CHO, 6% protein and 5% fat. The 6% protein in this test meal is Caseinate.	Dietary supplement: Caseinate; The test meal is a vanilla flavoured enteral drink, containing 1.5kcal/ml, 21% CHO, 6% protein and 5% fat. The 6% protein in this test meal is Caseinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Protein utilization	Up to 8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood glucose concentrations	Up to 8 hours
Plasma insulin levels	Up to 8 hours
Serum triglycerides	Up to 8 hours

Collaborators and Investigators

• Sponsor: University College Cork
• Investigators: Principal Investigator: Fergus Shanahan, MD, BSc, University College Cork

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (ESTIMATE): May 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 16, 2013
• Last Update Submitted That Met QC Criteria: January 15, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: APC032