Assessment of the Optimal Amount of Proteins at Breakfast for Children

Healthy Children Clinical Trial

Official title:

Assessment of the Optimal Amount of Proteins at Breakfast for Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465151
• Other study ID #: 14.09.NRC
• Status: Completed
• Phase: N/A
• First received: May 21, 2015
• Last updated: December 7, 2016
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 10 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Children

Intervention

Other:
• Protein-based beverage
protein-based beverage

Locations

Country	Name	City	State
Canada	Goldring Centre for High Performance Sport at University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body protein balance (g protein/9 hours) by nitrogen balance technique		9 hours following ingestion of investigational product	No
Secondary	Whole body protein balance (g protein/24 hours) by nitrogen balance technique		24 hours following ingestion of investigational product	No