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Assessment of the Optimal Amount of Proteins at Breakfast for Children

NCT ID: NCT02465151

Last Updated: 2016-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-08-31

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.

Conditions

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Healthy Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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No Protein

Group Type EXPERIMENTAL

Protein-based beverage

Intervention Type OTHER

protein-based beverage

Low Protein

Group Type EXPERIMENTAL

Protein-based beverage

Intervention Type OTHER

protein-based beverage

Medium Protein

Group Type EXPERIMENTAL

Protein-based beverage

Intervention Type OTHER

protein-based beverage

High Protein

Group Type EXPERIMENTAL

Protein-based beverage

Intervention Type OTHER

protein-based beverage

Interventions

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Protein-based beverage

protein-based beverage

Intervention Type OTHER

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Moore

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Goldring Centre for High Performance Sport at University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 30053279 (View on PubMed)

Other Identifiers

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14.09.NRC

Identifier Type: -

Identifier Source: org_study_id