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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02755558

Enrollment

143

Registered

2016-04-29

Start date

2014-09-30

Completion date

2015-05-31

Last updated

2017-03-21

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

Conditions

Feeding Behaviors

Brief summary

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.

Interventions

BEHAVIORALLow energy density

Low energy density milk served

BEHAVIORALHigh energy density

High energy density milk served

BEHAVIORALSmall portion

Small portion of milk served

BEHAVIORALLarge portion

Large portion of milk served

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

3 Years to 6 Years

Healthy volunteers

Yes

Inclusion criteria

* Children must be enrolled in participating childcare centers

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Difference between experimental conditions for milk, food, and total intake by weight	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)
Difference between experiential conditions for milk, food, and total intake by energy	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

Measure	Time frame	Description
Meal energy density	once a week for 4 weeks	Meal energy density (energy density in kcal/g)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026