Clinical trial NCT02465151: Assessment of the Optimal Amount of Proteins at Breakfast for Children
Official title: Assessment of the Optimal Amount of Proteins at Breakfast for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Children
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-06-08
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Whole body protein balance (g protein/9 hours) by nitrogen balance technique
timeFrame: 9 hours following ingestion of investigational product
Secondary outcomes:
measure: Whole body protein balance (g protein/24 hours) by nitrogen balance technique
timeFrame: 24 hours following ingestion of investigational product
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport at University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Dan Moore
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.