Assessment of the Optimal Amount of Proteins at Breakfast for Children

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT02465151

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Children	Other: Protein-based beverage	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

Official Title:

Assessment of the Optimal Amount of Proteins at Breakfast for Children

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: No Protein	Other: Protein-based beverage protein-based beverage
Experimental: Low Protein	Other: Protein-based beverage protein-based beverage
Experimental: Medium Protein	Other: Protein-based beverage protein-based beverage
Experimental: High Protein	Other: Protein-based beverage protein-based beverage

Outcome Measures

Primary Outcome Measures

Whole body protein balance (g protein/9 hours) by nitrogen balance technique [9 hours following ingestion of investigational product]

Secondary Outcome Measures

Whole body protein balance (g protein/24 hours) by nitrogen balance technique [24 hours following ingestion of investigational product]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Goldring Centre for High Performance Sport at University of Toronto	Toronto	Ontario	Canada	M5S 2C9

Sponsors and Collaborators

Nestlé

Investigators

Principal Investigator: Dan Moore, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nestlé

ClinicalTrials.gov Identifier:

NCT02465151

Other Study ID Numbers:

14.09.NRC

First Posted:

Jun 8, 2015

Last Update Posted:

Dec 8, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Dec 8, 2016