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

NCT ID: NCT01599988

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-04-30

Brief Summary

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.

Conditions

Enteral Feeds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Milk Protein Isolate

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: ACTIVE_COMPARATOR

Caseinate

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College Cork

OTHER

Sponsor Role: lead

Responsible Party

Andrea Doolan

Human Studies Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fergus Shanahan, MD, BSc

Role: PRINCIPAL_INVESTIGATOR

University College Cork

Locations

University College Cork

Cork, , Ireland

Countries

Ireland

Other Identifiers

APC032

Identifier Type: -

Identifier Source: org_study_id