Overview

This trial is active, not recruiting.

Condition child
Treatment nutrition
Phase phase 1
Sponsor McMaster University
Collaborator Nestec Ltd.
Start date October 2011
End date January 2014
Trial size 36 participants
Trial identifier NCT01598935, 10.44.NRC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Arm
(Placebo Comparator)
placebo
nutrition
protein-based food
(Active Comparator)
Nutrition - High protein
nutrition
protein-based food
(Active Comparator)
Nutrition - Low protein
nutrition
protein-based food
(Active Comparator)
Nutrition - Medium protein
nutrition
protein-based food

Primary Outcomes

Measure
Whole body protein balance
time frame: Participants will be followed for 10 days prior to assessment of whole body protein balance.

Secondary Outcomes

Measure
Whole body protein metabolism, metabolites
time frame: Participants will be followed for 10 days prior to assessment of whole body protein metabolism and metabolites

Eligibility Criteria

Male or female participants from 10 years up to 12 years old.

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).

Additional Information

Official title Double Blind Controlled Trial of Protein in Active Children
Principal investigator Brian W Timmons, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by McMaster University.