Energy Content and Energy Density of Pre-portioned Entrees

NCT ID: NCT01349023

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-12-31

Brief 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.

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

Standard Energy content/Standard ED

Group Type: EXPERIMENTAL

Energy density (ED), Energy content

Intervention Type: OTHER

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

Standard Energy content/Reduced ED

Group Type: EXPERIMENTAL

Energy density (ED), Energy content

Intervention Type: OTHER

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

Reduced Energy content/Standard ED

Group Type: EXPERIMENTAL

Energy density (ED), Energy content

Intervention Type: OTHER

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

Reduced Energy content/Reduced ED

Group Type: EXPERIMENTAL

Energy density (ED), Energy content

Intervention Type: OTHER

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

Interventions

Energy density (ED), Energy content

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Barbara J. Rolls

Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

Other Identifiers

R01DK059853

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R37DK039177

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FoodED301

Identifier Type: -

Identifier Source: org_study_id