Healthy ChildrenNCT02465151
Assessment of the Optimal Amount of Proteins at Breakfast for Children
A study testing Protein-based beverage in people with Healthy Children, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
Trial summary
The primary objective of this trial is to identify how much protein is required at breakfast to promote positive whole body protein balance over the following 9h period. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- Protein-based beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Aug 2016
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 7-12 years of age
- Healthy and recreationally physically active (obtaining a 3- day average moderate/vigorous physical activity of at least 30 min/day)
- Body mass at ≥10th percentile for 7 year olds and ≤85th percentile for 12 year olds. Values based upon 2000 CDC Growth Charts for the United States
- Having obtained his/her informed assent
- Having obtained his/her consent from parent or legal guardian
- Being able to communicate in local language
- Have a habitual daily protein consumption of between 1.6 g/kg and 2.4 g/kg/bw
Who cannot join
- Self-report on regular medication impacting the metabolism, such as corticoids, hormone (e.g thyroid, adrenal) treatment, or medication against diabetes or against hypercholesterolemia or hypertriglyceridemia
- Self-reported history of metabolic, hepatic or renal disease
- Self-reported allergy to milk proteins (e.g., whey or casein) or intolerance to any food ingredients to be used in the study products and meals
- Within 1.5 years of estimated age of peak height velocity (PHV)
- Special diet or weight loss program (e.g Atkins diet)
- Consuming breakfast containing more than 21g of protein on each day of the 3-d screening period
- Subject who cannot be expected to comply with the study procedures, including unwillingness to consume study product and meals
- Currently participating or having participated in another nutritional-clinical trial during the last 2 months prior to the beginning of this study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport at University of Toronto
Toronto, Ontario, M5S 2C9
About this study
The primary objective of this trial is to identify how much protein is required at breakfast to promote positive whole body protein balance over the following 9h period.
Read the detailed description
This study will be the first to establish the role of eating protein at breakfast on whole body protein balance in healthy children.
- Conditions
- Healthy Children
- Being tested
- Protein-based beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein-based beverageOther
protein-based beverage
| Study group | Role | What they receive |
|---|---|---|
| No Protein | Experimental | Not described Receives: Other: Protein-based beverage |
| Low Protein | Experimental | Not described Receives: Other: Protein-based beverage |
| Medium Protein | Experimental | Not described Receives: Other: Protein-based beverage |
| High Protein | Experimental | Not described Receives: Other: Protein-based beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body protein balance (g protein/9 hours) by nitrogen balance technique
Measured: 9 hours following ingestion of investigational product
Secondary outcomes (1)
Whole body protein balance (g protein/24 hours) by nitrogen balance technique
Measured: 24 hours following ingestion of investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionAug 2016
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 Healthy ChildrenStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Moore, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465151
- Sponsor's protocol ID
- 14.09.NRC
- Status last verified
- Dec 2016
- First submitted
- 21 May 2015
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Karagounis LG, Volterman KA, Breuille D, Offord EA, Emady-Azar S, Moore DR. Protein Intake at Breakfast Promotes a Positive Whole-Body Protein Balance in a Dose-Response Manner in Healthy Children: A Randomized Trial. J Nutr. 2018 May 1;148(5):729-737. doi: 10.1093/jn/nxy026.
PubMed 30053279
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Optimal Amount of Proteins at Breakfast for Children
- ClinicalTrials.gov ID
- NCT02465151
- Acronym / sponsor ID
- 14.09.NRC
- Conditions
- Healthy Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Jun 2015 (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.
The primary objective of this trial is to identify how much protein is required at breakfast to promote positive whole body protein balance over the following 9h period.
Detailed description
This study will be the first to establish the role of eating protein at breakfast on whole body protein balance in healthy children.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Protein | Experimental | Other: Protein-based beverage |
| Low Protein | Experimental | Other: Protein-based beverage |
| Medium Protein | Experimental | Other: Protein-based beverage |
| High Protein | Experimental | Other: Protein-based beverage |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged between 7-12 years of age
- Healthy and recreationally physically active (obtaining a 3- day average moderate/vigorous physical activity of at least 30 min/day)
- Body mass at ≥10th percentile for 7 year olds and ≤85th percentile for 12 year olds. Values based upon 2000 CDC Growth Charts for the United States
- Having obtained his/her informed assent
- Having obtained his/her consent from parent or legal guardian
Key exclusion criteria (8 listed)
- Self-report on regular medication impacting the metabolism, such as corticoids, hormone (e.g thyroid, adrenal) treatment, or medication against diabetes or against hypercholesterolemia or hypertriglyceridemia
- Self-reported history of metabolic, hepatic or renal disease
- Self-reported allergy to milk proteins (e.g., whey or casein) or intolerance to any food ingredients to be used in the study products and meals
- Within 1.5 years of estimated age of peak height velocity (PHV)
- Special diet or weight loss program (e.g Atkins diet)
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 |
|---|---|---|
| Protein-based beverageprotein-based beverage | Other | High Protein, Low Protein, Medium Protein, No Protein |
Primary outcome
Whole body protein balance (g protein/9 hours) by nitrogen balance technique
Time frame: 9 hours following ingestion of investigational product
1 secondary outcome
Whole body protein balance (g protein/24 hours) by nitrogen balance technique
Time frame: 24 hours following ingestion of investigational product
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 8 Dec 2016.
- Derived from this study: PubMed 30053279Karagounis LG, Volterman KA, Breuille D, Offord EA, Emady-Azar S, Moore DR. Protein Intake at Breakfast Promotes a Positive Whole-Body Protein Balance in a Dose-Response Manner in Healthy Children: A Randomized Trial. J Nutr. 2018 May 1;148(5):729-737. doi: 10.1093/jn/nxy026.
- Individual participant dataSharing planned: No
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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.
Dan Moore principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein-based beverage in people with Healthy Children, run by Société des Produits Nestlé (SPN) 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 7 inclusion and 8 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 8 Dec 2016. 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. 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 (g protein/9 hours) by nitrogen balance technique (time frame: 9 hours following ingestion of investigational product). 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 NCT02465151, 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 8 Dec 2016.