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Post-exercise Protein Intake for Active Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by McMaster University.
Recruitment status was:  Active, not recruiting
Nestec Ltd.
Information provided by (Responsible Party):
McMaster University Identifier:
First received: February 16, 2012
Last updated: June 12, 2013
Last verified: June 2013
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 (Participant, 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. ]
    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 ]
    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
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


Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01598935

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

Responsible Party: McMaster University Identifier: NCT01598935     History of Changes
Other Study ID Numbers: 10.44.NRC
Study First Received: February 16, 2012
Last Updated: June 12, 2013 processed this record on August 18, 2017