Children's Intake of Foods Reduced in Energy Density

Vegetable Intake Clinical Trial

Official title:

Children's Intake of Foods Reduced in Energy Density

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252433
• Other study ID #: FoodED201
• Secondary ID: R01DK082580
• Status: Completed
• Phase: N/A
• First received: December 2, 2010
• Last updated: March 15, 2012
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: March 2012
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• enrolled in daycare centers at Penn State University

Exclusion Criteria:

• food allergies or intolerances

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vegetable Intake

Intervention

Other:
• Energy density feeding study
In a crossover study, children are served all foods 1 day a week for 3 weeks. Meal entrees will vary in energy density (100%, 85%, 75%).

Locations

Country	Name	City	State
United States	The Pennsylvania State University	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	Food intake		1 month	No
Secondary	Energy intake		1 month	No