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Completed

NCT Number: NCT01599988

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

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.

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Key information

Conditions

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University College Cork

Cork, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 30.
  • 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

Treatment and study plan

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

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.

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

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

A Randomised, Double-blinded Study to Compare Milk Protein Isolate (MPI)With Caseinate in Terms of Protein Utilization in Healthy Elderly Subjects

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 16, 2012
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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