Assessment of the Optimal Amount of Proteins at Breakfast for Children

NCT02465151 | Completed

• 1 other identifier: 14.09.NRC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Children

Outcome Measures

Primary Outcomes (1)

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

  9 hours following ingestion of investigational product

Secondary Outcomes (1)

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

  24 hours following ingestion of investigational product

Study Arms (4)

No Protein

EXPERIMENTAL

Other: Protein-based beverage

Low Protein

EXPERIMENTAL

Other: Protein-based beverage

Medium Protein

EXPERIMENTAL

Other: Protein-based beverage

High Protein

EXPERIMENTAL

Other: Protein-based beverage

Interventions

Protein-based beverage OTHER

protein-based beverage

High Protein; Low Protein; Medium Protein; No Protein

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Goldring Centre for High Performance Sport at University of Toronto

Toronto, Ontario, M5S 2C9, Canada

Location

Related Publications (1)

• 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.

  PMID: 30053279 DERIVED

Study Officials

• Dan Moore

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: June 8, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)