Post-exercise Protein Intake for Active Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Nestec Ltd.
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01598935
First received: February 16, 2012
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

Today, there is an important lack of knowledge on the effects of dietary protein on protein metabolism after physical activity in children. Here, the investigators will measure changes in whole body protein metabolism using minimally invasive techniques and stable isotope methodology at rest and after physical activity with the intake of milk protein.


Condition Intervention Phase
Child
Other: nutrition
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Double Blind Controlled Trial of Protein in Active Children

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Whole body protein balance [ Time Frame: Participants will be followed for 10 days prior to assessment of whole body protein balance. ] [ Designated as safety issue: No ]
    Whole body protein balance will be measured by stable isotopes.


Secondary Outcome Measures:
  • Whole body protein metabolism, metabolites [ Time Frame: Participants will be followed for 10 days prior to assessment of whole body protein metabolism and metabolites ] [ Designated as safety issue: No ]
    Whole body protein metabolism by stable isotopes and metabolite concentrations in plasma and urine.


Estimated Enrollment: 36
Study Start Date: October 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
placebo
Other: nutrition
protein-based food
Active Comparator: High protein intake
Nutrition - High protein
Other: nutrition
protein-based food
Active Comparator: Low protein intake
Nutrition - Low protein
Other: nutrition
protein-based food
Active Comparator: Medium protein intake
Nutrition - Medium protein
Other: nutrition
protein-based food

  Eligibility

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy and physically active (as determined by medical and activity questionnaire)
  • 10-12 years of age
  • Within approximately 2 years of estimated age of peak height velocity (PHV)
  • Minimum aerobic fitness of 35 ml/kg/min as assessed by the McMaster All-out Progressive Continuous Cycling Protocol
  • Having obtained his/her informed assent
  • Having obtained his/her legal representative's informed consent

Exclusion Criteria:

  • Post-pubertal
  • Taking any medication
  • Smoker
  • Undergoing medical treatment or investigations
  • Body mass index > 24
  • Suffer from chronic diseases (with regular intake of drugs, medical history)
  • Vegetarians
  • Vaccination in the last 4 months
  • Any know food allergies or intolerance
  • Pregnancy
  • Special diet or weight loss program (e.g. Atkins diet)
  • Acute illness
  • Fever, cold, flu
  • Participation in a cholesterol management program with functional foods like food supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols (margarines, yoghurts).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598935

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
McMaster University
Nestec Ltd.
Investigators
Principal Investigator: Brian W Timmons, PhD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01598935     History of Changes
Other Study ID Numbers: 10.44.NRC
Study First Received: February 16, 2012
Last Updated: June 12, 2013
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on April 16, 2014