Assessment of the Optimal Amount of Proteins at Breakfast for Children

December 7, 2016 updated by: Société des Produits Nestlé (SPN)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 2C9
        • Goldring Centre for High Performance Sport at University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No Protein
Other: Protein-based beverage
protein-based beverage
Experimental: Low Protein
Other: Protein-based beverage
protein-based beverage
Experimental: Medium Protein
Other: Protein-based beverage
protein-based beverage
Experimental: High Protein
Other: Protein-based beverage
protein-based beverage

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Dan Moore, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 14.09.NRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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