Effect of Energy Density Over 5 Days in Preschool Children

Feeding Behavior Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010501
• Other study ID #: ChildFood502
• Secondary ID: R01DK082580
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2019
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the investigators will vary the energy density of foods served during three 5-day periods. There will be a baseline condition, and then a condition where the energy density of food is lower and a condition where the energy density of food is higher. The primary aim is to determine the effect of varying the energy density of foods served over 5 days on energy intake in preschool children. It is hypothesized that mean daily energy intake will be greater when children are served higher energy dense foods over 5 days than when served lower energy dense foods over the same period. Additionally, it is hypothesized that daily energy intake in the conditions with higher and lower energy densities will begin to converge across the 5-day period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• Attending one of the designated daycare centers

Exclusion Criteria:

• Food Allergies

• Food restrictions

• Health Issues that Preclude Participation

• Not available for duration of the study

Related Conditions & MeSH terms

• Feeding Behavior

Intervention

Other:
• Food Energy Density
Food Energy density manipulated

Locations

Country	Name	City	State
United States	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	Differences in Food and Beverage Intake by Energy	Differences in daily intake of food and beverages by energy, in kcal	Days 1-5 in Weeks 1, 2, and 3
Primary	Differences in Food and Beverage Intake by Weight	Differences in daily intake of food and beverages by weight, in grams	Days 1-5 in weeks 1, 2, and 3
Secondary	Differences in Food and Beverage Intake by Energy Density	Differences in daily intake of food and beverages by energy density, in kcal/g	Days 1-5 in weeks 1, 2, and 3