Assessment of the Optimal Amount of Proteins at Breakfast... | NCT02465151

Studies
Assessment of the Optimal Amount of Proteins at Breakfast for Children

NCT02465151

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Dec 8, 2016Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Healthy Children

Interventions

Protein-based beverage

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

May 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

May 21, 2015

First Submission Date that Met QC Criteria

Jun 3, 2015

First Posted Date

Jun 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2016

Last Update Posted Date

Dec 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protein-based beverage	Other	protein-based beverage	High Protein Low Protein Medium Protein No Protein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Whole body protein balance (g protein/9 hours) by nitrogen balance technique		9 hours following ingestion of investigational product

Secondary Outcomes

Measure	Description	Time Frame
Whole body protein balance (g protein/24 hours) by nitrogen balance technique		24 hours following ingestion of investigational product

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dan Moore	University of Toronto	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Goldring Centre for High Performance Sport at University of Toronto		Toronto	Ontario	M5S 2C9	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30053279	Derived	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.