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

Feeding Behaviors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755558
• Other study ID #: ChildFood301
• Secondary ID: R01DK0825802011-
• Status: Completed
• Phase: N/A
• First received: April 22, 2016
• Last updated: March 17, 2017
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2017
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• Children must be enrolled in participating childcare centers

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Feeding Behaviors

Intervention

Behavioral:
• Low energy density
Low energy density milk served
• High energy density
High energy density milk served
• Small portion
Small portion of milk served
• Large portion
Large portion of milk served

Locations

Country	Name	City	State
United States	The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between experimental conditions for milk, food, and total intake by weight	Difference between experimental conditions in milk intake (weight in grams), food intake (weight in grams), total meal intake (weight in grams)	once a week for 4 weeks
Primary	Difference between experiential conditions for milk, food, and total intake by energy	Difference between experimental conditions for milk intake (energy in kcal), food intake (energy in kcal), and total meal energy intake (energy in kcal)	once a week for 4 weeks
Secondary	Meal energy density	Meal energy density (energy density in kcal/g)	once a week for 4 weeks