NCT01349023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

2.9 years

First QC Date

May 3, 2011

Last Update Submit

March 15, 2012

Conditions

Keywords

energy contentenergy densityenergy intakepre-portioned entrees

Outcome Measures

Primary Outcomes (1)

  • Daily Energy Intake (kcal/day)

    1 month

Study Arms (4)

Standard Energy content/Standard ED

EXPERIMENTAL
Other: Energy density (ED), Energy content

Standard Energy content/Reduced ED

EXPERIMENTAL
Other: Energy density (ED), Energy content

Reduced Energy content/Standard ED

EXPERIMENTAL
Other: Energy density (ED), Energy content

Reduced Energy content/Reduced ED

EXPERIMENTAL
Other: Energy density (ED), Energy content

Interventions

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

Reduced Energy content/Reduced EDReduced Energy content/Standard EDStandard Energy content/Reduced EDStandard Energy content/Standard ED

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior

Study Record Dates

First Submitted

May 3, 2011

First Posted

May 6, 2011

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations