Energy Content and Energy Density of Pre-portioned Entrees (EDEN)

March 15, 2012 updated by: Barbara J. Rolls, Penn State University

Effects of Energy Density and Energy Content of Pre-portioned entrées on Energy Intake

Pre-portioned entrées are commonly consumed to help control portion size and limit energy intake. Few studies, however, have investigated the influence of the characteristics of pre-portioned entrées on energy intake. This study investigates how the characteristics of solid pre-portioned entrées, specifically, variations in their energy content and energy density influence energy intake over a day. The investigators hypothesize that reducing the energy content and energy density of compulsory entrées will act independently and add together to reduce daily energy intake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This experiment uses a crossover design with repeated measures within subjects. One day a week for four weeks, participants are provided with all of their foods and beverages for breakfast, lunch, and dinner meals. Across test days, the entrée at each meal is varied in both energy content and energy density between a standard level (100%) and a reduced level (64% of the standard). Following consumption of a compulsory entrée, a variety of unmanipulated foods will be served for ad libitum consumption. The order of experimental conditions is counterbalanced across the subjects.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • The Pennsylvania State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • regularly eat three meals per day
  • do not smoke
  • do not have any food allergies or restrictions
  • are not athletes in training
  • are not dieting
  • are not taking medications that would affect appetite
  • are willing to consume the foods served in the test meals

Exclusion Criteria:

  • a score > 40 on the Zung scale
  • a score > 20 on the Eating Attitudes Test
  • reported known health problems
  • weight not maintained within 10 lb during the 6 months before the start of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Energy content/Standard ED
Other: Energy density (ED), Energy content
Standard or reduced energy content and energy density of pre-portioned entrees
Experimental: Standard Energy content/Reduced ED
Other: Energy density (ED), Energy content
Standard or reduced energy content and energy density of pre-portioned entrees
Experimental: Reduced Energy content/Standard ED
Other: Energy density (ED), Energy content
Standard or reduced energy content and energy density of pre-portioned entrees
Experimental: Reduced Energy content/Reduced ED
Other: Energy density (ED), Energy content
Standard or reduced energy content and energy density of pre-portioned entrees

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily Energy Intake (kcal/day)
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 3, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (Estimate)

May 6, 2011

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 15, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FoodED301
  • R01DK059853 (U.S. NIH Grant/Contract)
  • R37DK039177 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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