Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Doolan, University College Cork
ClinicalTrials.gov Identifier:
NCT01599988
First received: March 13, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Enteral Feeds
 Dietary Supplement: Caseinate
Dietary Supplement: Milk Protein Isolate
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomised, Double-blinded Study to Compare Milk Protein Isolate (MPI)With Caseinate in Terms of Protein Utilization in Healthy Elderly Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College Cork:

Primary Outcome Measures:
  • Protein utilization [ Time Frame: Up to 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood glucose concentrations [ Time Frame: Up to 8 hours ] [ Designated as safety issue: No ]
  • Plasma insulin levels [ Time Frame: Up to 8 hours ] [ Designated as safety issue: No ]
  • Serum triglycerides [ Time Frame: Up to 8 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599988

Locations
Ireland
University College Cork
Cork, Ireland
Sponsors and Collaborators
University College Cork
Investigators
Principal Investigator: Fergus Shanahan, MD, BSc University College Cork
  More Information

No publications provided

Responsible Party: Andrea Doolan, Human Studies Manager, University College Cork
ClinicalTrials.gov Identifier: NCT01599988     History of Changes
Other Study ID Numbers: APC032
Study First Received: March 13, 2012
Last Updated: January 15, 2013
Health Authority: Ireland: Medical Ethics Research Committee

ClinicalTrials.gov processed this record on May 23, 2013