Assessment of the Optimal Amount of Proteins at Breakfast for Children

N

Nestlé

Status

Completed

Conditions

Healthy Children

Treatments

Other: Protein-based beverage

Study type

Interventional

Funder types

Industry

Identifiers

NCT02465151
14.09.NRC

Details and patient eligibility

About

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.

Full description

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

Enrollment

32 patients

Sex

All

Ages

7 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

32 participants in 4 patient groups

No Protein
Experimental group
Treatment:
Other: Protein-based beverage
Low Protein
Experimental group
Treatment:
Other: Protein-based beverage
Medium Protein
Experimental group
Treatment:
Other: Protein-based beverage
High Protein
Experimental group
Treatment:
Other: Protein-based beverage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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