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CompletedNCT01349023EDENUpdated Mar 16, 2012

Energy Content and Energy Density of Pre-portioned Entrees

An interventional study of Energy density (ED), Energy content in Obesity, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-16.

Sponsored by Penn State University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • energy content
  • energy density
  • energy intake
  • pre-portioned entrees
03

In context

Lead sponsor

Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    Standard Energy content/Standard ED

    Other: Energy density (ED), Energy content

  • Experimental
    Standard Energy content/Reduced ED

    Other: Energy density (ED), Energy content

  • Experimental
    Reduced Energy content/Standard ED

    Other: Energy density (ED), Energy content

  • Experimental
    Reduced Energy content/Reduced ED

    Other: Energy density (ED), Energy content

Interventions

  • OtherEnergy density (ED), Energy content

    Standard or reduced energy content and energy density of pre-portioned entrees

06

What researchers measure

Primary outcomes

  1. Daily Energy Intake (kcal/day)

    Time frame: 1 month

07

Study locations

1 site
  • The Pennsylvania State University
    University Park, Pennsylvania 16802, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01349023
Lead sponsor
Penn State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Barbara J. Rolls (Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior, Penn State University) — Principal investigator
First posted
May 6, 2011
Start date
Jan 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Mar 16, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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