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Clinical Trials/NCT01598935
NCT01598935CompletedNot Applicable

Double Blind Controlled Trial of Protein in Active Children

McMaster University2 sites in 1 country36 target enrollmentStarted: October 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
2
Primary Endpoint
Whole body protein balance

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
10 Years to 12 Years (Child)
Sex
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
  • 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).

Outcomes

Primary Outcomes

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 Outcomes

  • Whole body protein metabolism, metabolites(Participants will be followed for 10 days prior to assessment of whole body protein metabolism and metabolites)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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