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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01598935
Other study ID # 10.44.NRC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2011
Est. completion date August 2015

Study information

Verified date August 2022
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 12 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
nutrition
protein-based food

Locations

Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
McMaster University Nestec Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Whole body protein balance Whole body protein balance will be measured by stable isotopes. Participants will be followed for 10 days prior to assessment of whole body protein balance.
Secondary Whole body protein metabolism, metabolites Whole body protein metabolism by stable isotopes and metabolite concentrations in plasma and urine. Participants will be followed for 10 days prior to assessment of whole body protein metabolism and metabolites
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