Protein for Active Children

This study is currently recruiting participants.

Verified May 2012 by McMaster University

Sponsor:

Collaborator:

Nestec Ltd.

Information provided by (Responsible Party):

McMaster University

ClinicalTrials.gov Identifier:

NCT01598935

First received: February 16, 2012

Last updated: May 11, 2012

Last verified: May 2012

History of Changes

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
Healthy Children	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:	August 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Control	Other: nutrition protein-based food
Active Comparator: High	Other: nutrition protein-based food
Active Comparator: Low	Other: nutrition protein-based food
Active Comparator: Medium	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

Contacts

Contact: Brian W Timmons, PhD

905-521-2100 ext 77615

timmonbw@mcmaster.ca

Locations

Canada, Ontario
McMaster University	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Brian W Timmons, PhD 905-521-2100 ext 77615 timmonbw@mcmaster.ca
Principal Investigator: Brian W Timmons, PhD

Sponsors and Collaborators

McMaster University

Nestec Ltd.

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:	May 11, 2012
Health Authority:	Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on October 17, 2012

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