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OpenTrials
Completed

NCT Number: NCT02755558

Effects of Energy Density and Portion Size of Milk in Preschool Children

In this study, the investigators varied both the energy density and portion size of milk served with a meal commonly consumed by preschool children. The milk used in this study is commercially available and reflects typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of milk energy density and portion size on preschool children's intake of the milk and the simultaneously served meal. The effect of milk energy density and portion size on children's total energy intake at the meal will also be evaluated.

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Key information

Conditions

Feeding Behaviors Behavior Behavior, Animal Feeding Behavior

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children must be enrolled in participating childcare centers

Exclusion criteria

  • Allergy or intolerance to any of the foods or beverages served

Treatment and study plan

Low energy density

Behavioral

Low energy density milk served

High energy density

Behavioral

High energy density milk served

Small portion

Behavioral

Small portion of milk served

Large portion

Behavioral

Large portion of milk served

Primary outcomes

  1. Difference between experimental conditions for milk, food, and total intake by weight

    Time frame: once a week for 4 weeks

    Difference between experimental conditions in milk intake (weight in grams), food intake (weight in grams), total meal intake (weight in grams)

  2. Difference between experiential conditions for milk, food, and total intake by energy

    Time frame: once a week for 4 weeks

    Difference between experimental conditions for milk intake (energy in kcal), food intake (energy in kcal), and total meal energy intake (energy in kcal)

Secondary outcomes

  1. Meal energy density

    Time frame: once a week for 4 weeks

    Meal energy density (energy density in kcal/g)

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2016
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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