NCT01599988CompletedPhase 2
A Randomised, Double-blinded Study to Compare Milk Protein Isolate (MPI)With Caseinate in Terms of Protein Utilization in Healthy Elderly Subjects
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University College Cork
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Protein utilization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 75 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •To be considered eligible for enrolment into the study, subjects must;
- •Be able to give written informed consent.
- •Be between 65 and 75 years of age.
- •Be in generally good health as determined by the investigator.
- •Have no evidence of gastrointestinal disease or of a functional gastrointestinal disorder as determined by the Bowel Disease Questionnaire.
- •Have a stable body weight over the past 3-months.
- •Have a Body Mass Index (BMI) greater than 22, for males and 20 for females and less than
- •Have a satisfactory nutritional status.
Exclusion Criteria
- •Subjects will be excluded from the study if they meet any of the below criteria;
- •Are less than 65 and greater than 75 years of age.
- •Have evidence of gastrointestinal disease or other functional gastrointestinal disorder as determined by the Bowel Disease Questionnaire.
- •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).
- •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.
- •Be a smoker.
- •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.
- •Suffer from psychiatric disease
- •Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or recent unexplained bleeding.
- •Have dietary habits (slimming or vegetarian diet) which could interfere with the assessment of the study product.
- •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.
- •Subjects may not be receiving treatment involving experimental drugs.
- •If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
- •Have a malignant disease or any concomitant end-stage organ disease
Arms & Interventions
Milk protein isolate
Active Comparator
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: Milk Protein Isolate (Dietary Supplement)
Caseinate
Active Comparator
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: Caseinate (Dietary Supplement)
Outcomes
Primary Outcomes
Protein utilization
Time Frame: Up to 8 hours
Secondary Outcomes
- Blood glucose concentrations(Up to 8 hours)
- Plasma insulin levels(Up to 8 hours)
- Serum triglycerides(Up to 8 hours)
Investigators
Andrea Doolan
Human Studies Manager
University College Cork
Study Sites (1)
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