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

March 13, 2012
January 15, 2013
October 2011
March 2012   (final data collection date for primary outcome measure)
Protein utilization [ Time Frame: Up to 8 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01599988 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Enteral Feeds
  • 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
  • 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: 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: Dietary Supplement: 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.
    Intervention: Dietary Supplement: Caseinate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
65 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT01599988
APC032
No
Andrea Doolan, University College Cork
University College Cork
Not Provided
Principal Investigator: Fergus Shanahan, MD, BSc University College Cork
University College Cork
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP