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Completed

NCT Number: NCT02465151

Assessment of the Optimal Amount of Proteins at Breakfast for Children

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.

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Key information

Conditions

Healthy Children

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goldring Centre for High Performance Sport at University of Toronto

Toronto, Ontario, M5S 2C9, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein-based beverage

Other

protein-based beverage

Primary outcomes

  1. Whole body protein balance (g protein/9 hours) by nitrogen balance technique

    Time frame: 9 hours following ingestion of investigational product

Secondary outcomes

  1. Whole body protein balance (g protein/24 hours) by nitrogen balance technique

    Time frame: 24 hours following ingestion of investigational product

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2015
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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