NCT01598935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

3.8 years

First QC Date

February 16, 2012

Last Update Submit

August 23, 2022

Conditions

Child

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Whole body protein metabolism, metabolites

    Participants will be followed for 10 days prior to assessment of whole body protein metabolism and metabolites

Study Arms (4)

Control

PLACEBO COMPARATOR

placebo

Other: nutrition

High protein intake

ACTIVE COMPARATOR

Nutrition - High protein

Other: nutrition

Low protein intake

ACTIVE COMPARATOR

Nutrition - Low protein

Other: nutrition

Medium protein intake

ACTIVE COMPARATOR

Nutrition - Medium protein

Other: nutrition

Interventions

nutritionOTHER

protein-based food

ControlHigh protein intakeLow protein intakeMedium protein intake

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy and physically active (as determined by medical and activity questionnaire)
  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

  • Volterman KA, Moore DR, Breithaupt P, Godin JP, Karagounis LG, Offord EA, Timmons BW. Postexercise Dietary Protein Ingestion Increases Whole-Body Leucine Balance in a Dose-Dependent Manner in Healthy Children. J Nutr. 2017 May;147(5):807-815. doi: 10.3945/jn.116.239756. Epub 2017 Apr 5.

    PMID: 28381530DERIVED

MeSH Terms

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Brian W Timmons, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

May 15, 2012

Study Start

October 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations

CA(1)