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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Barbara J. Rolls, Penn State University
ClinicalTrials.gov Identifier:
NCT01349023
First received: May 3, 2011
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Other: Energy density (ED), Energy content

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Effects of Energy Density and Energy Content of Pre-portioned entrées on Energy Intake

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Daily Energy Intake (kcal/day) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349023

Locations
United States, Pennsylvania
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

No publications provided

Responsible Party: Barbara J. Rolls, Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior, Penn State University
ClinicalTrials.gov Identifier: NCT01349023     History of Changes
Other Study ID Numbers: FoodED301, R01DK059853, R37DK039177
Study First Received: May 3, 2011
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
energy content
energy density
energy intake
pre-portioned entrees

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013