Assessment of the Optimal Amount of Proteins at Breakfast for Children

Not Applicable

Completed

• Conditions: Healthy Children
• Interventions: Other: Protein-based beverage

• Registration Number: NCT02465151
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Primary Completion: 2016-05
• Study Completion: 2016-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-07
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Protein	Protein-based beverage	-
High Protein	Protein-based beverage	-
No Protein	Protein-based beverage	-
Medium Protein	Protein-based beverage	-

Primary Outcome Measures

Name	Time	Method
Whole body protein balance (g protein/9 hours) by nitrogen balance technique	9 hours following ingestion of investigational product

Secondary Outcome Measures

Name	Time	Method
Whole body protein balance (g protein/24 hours) by nitrogen balance technique	24 hours following ingestion of investigational product

Trial Locations

Locations (1)

Goldring Centre for High Performance Sport at University of Toronto; 🇨🇦 Toronto, Ontario, Canada