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Assessment of the Optimal Amount of Proteins at Breakfast for Children

Assessment of the Optimal Amount of Proteins at Breakfast for Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02465151
Enrollment
32
Registered
2015-06-08
Start date
2015-04-30
Completion date
2016-08-31
Last updated
2016-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Children

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.

Interventions

OTHERProtein-based beverage

protein-based beverage

Sponsors

Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
7 Years to 10 Years
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

Design outcomes

Primary

MeasureTime frame
Whole body protein balance (g protein/9 hours) by nitrogen balance technique9 hours following ingestion of investigational product

Secondary

MeasureTime frame
Whole body protein balance (g protein/24 hours) by nitrogen balance technique24 hours following ingestion of investigational product

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026