NCT01729390

Brief Summary

The purpose of this research is to determine whether varying the energy density and portion size of the main course will affect meal energy intake after consumption of a first course that has previously been shown to enhance satiety. It is hypothesized that increasing either the energy density or portion size of the main course will increase meal energy intake after consumption of the first course. It is also hypothesized that compared to when a first course is consumed, not consuming a first course will increase meal energy intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

1.2 years

First QC Date

November 14, 2012

Last Update Submit

November 14, 2012

Conditions

Keywords

Feeding behavior

Outcome Measures

Primary Outcomes (1)

  • Energy intake

    6 weeks

Secondary Outcomes (1)

  • Food intake

    6 weeks

Study Arms (6)

Std ED Control

EXPERIMENTAL

100% energy density and 133% portion size

Other: Energy density and portion size feeding study

Inc ED Control

EXPERIMENTAL

133% energy density and 133% portion size

Other: Energy density and portion size feeding study

Std ED and Std PS

EXPERIMENTAL

100% energy density and 100% portion size

Other: Energy density and portion size feeding study

Std ED and Inc PS

EXPERIMENTAL

100% energy density and 133% portion size

Other: Energy density and portion size feeding study

Inc ED and Inc PS

EXPERIMENTAL

133% energy density and 133% portion size

Other: Energy density and portion size feeding study

Inc ED and Std PS

EXPERIMENTAL

133% energy density and 100% portion size

Other: Energy density and portion size feeding study

Interventions

In a crossover design, adults are served breakfast and lunch, 1 day a week for 6 weeks. Breakfast is not varied across weeks. At 4 of the lunch meals, a salad first course will be served that needs to be eaten in its entirety. At these 4 meals the lunch entree will vary in energy density (100% and 133%) and portion size (100% and 133%). At the 2 lunch meals for which no first course is served, the lunch entree will be vary in energy density (100% and 133%) but be the same portion size (133%).

Inc ED ControlInc ED and Inc PSInc ED and Std PSStd ED ControlStd ED and Inc PSStd ED and Std PS

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults from Penn State and the surrounding community

You may not qualify if:

  • Currently dieting
  • Food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

ObesityFeeding Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Barbara J Rolls

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 20, 2012

Study Start

September 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations