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CompletedNCT01599988Updated Jan 16, 2013

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

A Phase 2/3 interventional study of Caseinate and Milk Protein Isolate in Enteral Feeds, sponsored by University College Cork. Completed at 1 site in Ireland. Open to participants aged 65 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-16.

Sponsored by University College Cork · Phase 2/3, Interventional, and Basic science

Phase
Phase 2/3
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
65 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Enteral Feeds
03

In context

Lead sponsor

University College Cork is the lead sponsor of 116 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementCaseinate

    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 supplementMilk 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.

06

What researchers measure

Primary outcomes

  1. Protein utilization

    Time frame: Up to 8 hours

Secondary outcomes

  1. Blood glucose concentrations

    Time frame: Up to 8 hours

  2. Plasma insulin levels

    Time frame: Up to 8 hours

  3. Serum triglycerides

    Time frame: Up to 8 hours

07

Study locations

1 site
  • University College Cork
    Cork, Ireland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01599988
Lead sponsor
University College Cork
Responsible party
Andrea Doolan (Human Studies Manager, University College Cork) — Principal investigator
First posted
May 16, 2012
Start date
Oct 2011
Primary completion
Mar 2012
Completion
Apr 2012
Last update
Jan 16, 2013

Study contacts

Fergus Shanahan, MD, BSc
principal investigator · University College Cork

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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