ChildNCT01598935
Post-exercise Protein Intake for Active Children
A study testing nutrition in people with Child, run by McMaster University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child
- What is being tested?
- nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Controlled Trial of Protein in Active Children
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.
- Conditions
- Child
- Being tested
- nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritionOther
protein-based food
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | placebo Receives: Other: nutrition |
| High protein intake | Active comparator | Nutrition - High protein Receives: Other: nutrition |
| Low protein intake | Active comparator | Nutrition - Low protein Receives: Other: nutrition |
| Medium protein intake | Active comparator | Nutrition - Medium protein Receives: Other: nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body protein balance
Whole body protein balance will be measured by stable isotopes.
Measured: Participants will be followed for 10 days prior to assessment of whole body protein balance.
Secondary outcomes (1)
Whole body protein metabolism, metabolites
Whole body protein metabolism by stable isotopes and metabolite concentrations in plasma and urine.
Measured: Participants will be followed for 10 days prior to assessment of whole body protein metabolism and metabolites
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startOct 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Nestec Ltd.
- Responsible party
- Sponsor
- Investigators
- Brian W Timmons, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598935
- Sponsor's protocol ID
- 10.44.NRC
- Status last verified
- Aug 2022
- First submitted
- 16 Feb 2012
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28381530
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Controlled Trial of Protein in Active Children
- ClinicalTrials.gov ID
- NCT01598935
- Acronym / sponsor ID
- 10.44.NRC
- Conditions
- Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Nestec Ltd.
- Study start
- Oct 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: nutritionplacebo |
| High protein intake | Active comparator | Other: nutritionNutrition - High protein |
| Low protein intake | Active comparator | Other: nutritionNutrition - Low protein |
| Medium protein intake | Active comparator | Other: nutritionNutrition - Medium protein |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Post-pubertal
- Taking any medication
- Smoker
- Undergoing medical treatment or investigations
- Body mass index > 24
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritionprotein-based food | Other | Control, High protein intake, Low protein intake, Medium protein intake |
Primary outcome
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.
1 secondary outcome
Whole body protein metabolism, metabolites
Time frame: Participants will be followed for 10 days prior to assessment of whole body protein metabolism and metabolites
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 28381530Volterman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian W Timmons, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition in people with Child, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body protein balance (time frame: Participants will be followed for 10 days prior to assessment of whole body protein balance.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01598935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.