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

NCT01599988 | Completed Phase 2

• 1 other identifier: APC032
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Protein utilization

  Up to 8 hours

Secondary Outcomes (3)

• Blood glucose concentrations

  Up to 8 hours

• Plasma insulin levels

  Up to 8 hours

• Serum triglycerides

  Up to 8 hours

Study Arms (2)

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.

Dietary Supplement: Milk Protein Isolate

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.

Dietary Supplement: Caseinate

Interventions

Caseinate 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

Caseinate

Milk Protein Isolate 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.

Milk protein isolate

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 30.
• Have a satisfactory nutritional status.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

University College Cork

Cork, Ireland

Location

Study Officials

• Fergus Shanahan, MD, BSc

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Human Studies Manager

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: May 16, 2012
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

IE (1)