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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03010501
Other study ID # ChildFood502
Secondary ID R01DK082580
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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