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OpenTrials
Completed

NCT Number: NCT03010501

Effect of Energy Density Over 5 Days in Preschool Children

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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food Energy Density

Other

Food Energy density manipulated

Primary outcomes

  1. Differences in Food and Beverage Intake by Energy

    Time frame: Days 1-5 in Weeks 1, 2, and 3

    Differences in daily intake of food and beverages by energy, in kcal

  2. Differences in Food and Beverage Intake by Weight

    Time frame: Days 1-5 in weeks 1, 2, and 3

    Differences in daily intake of food and beverages by weight, in grams

Secondary outcomes

  1. Differences in Food and Beverage Intake by Energy Density

    Time frame: Days 1-5 in weeks 1, 2, and 3

    Differences in daily intake of food and beverages by energy density, in kcal/g

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 5, 2017
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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