Assessment of the Optimal Amount of Proteins at Breakfast for Children

Study Overview
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Brief Summary
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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
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This study will be the first to establish the role of eating protein at breakfast on whole body protein balance in healthy children.

Official Title
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Assessment of the Optimal Amount of Proteins at Breakfast for Children

Conditions
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Healthy Children

Intervention / Treatment
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* Other: Protein-based beverage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No Protein<br> | Other: Protein-based beverage<br>* protein-based beverage<br>|
| Experimental: Low Protein<br> | Other: Protein-based beverage<br>* protein-based beverage<br>|
| Experimental: Medium Protein<br> | Other: Protein-based beverage<br>* protein-based beverage<br>|
| Experimental: High Protein<br> | Other: Protein-based beverage<br>* protein-based beverage<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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