Expired Study
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University Park, Pennsylvania 16802


Purpose:

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.


Criteria:

Inclusion Criteria: - enrolled in daycare centers at Penn State University Exclusion Criteria: - food allergies or intolerances


Study is Available At:


Original ID:

FoodED201


NCT ID:

NCT01252433


Secondary ID:

R01DK082580


Study Acronym:


Brief Title:

Children's Intake of Foods Reduced in Energy Density


Official Title:

Children's Intake of Foods Reduced in Energy Density


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

3 Years


Maximum Age:

6 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Penn State University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

49


Enrollment Type:

Actual


Study Dates

Start Date:January 2010
Completion Date:May 2010
Completion Type:Actual
Primary Completion Date:May 2010
Primary Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 15, 2012
First Received Date:December 2, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Energy intake
Time Frame:1 month
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Food intake
Time Frame:1 month
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Energy density feeding study
Description: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%).
Arm Name:Entree energy density 100%

Study Arms

Study Arm Type:Experimental
Arm Name:Entree energy density 75%
Description:75% energy density
Study Arm Type:Experimental
Arm Name:Entree energy density 85%
Description:85% energy density
Study Arm Type:Experimental
Arm Name:Entree energy density 100%
Description:100% energy density

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Penn State University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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