- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01729390
Varying the Energy Density and Portion Size of the Main Course After a First-course Salad
November 14, 2012 updated by: Barbara J. Rolls, Penn State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Adults from Penn State and the surrounding community
Exclusion Criteria:
- Currently dieting
- Food allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Std ED Control
100% energy density and 133% portion size
|
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%).
|
|
Experimental: Inc ED Control
133% energy density and 133% portion size
|
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%).
|
|
Experimental: Std ED and Std PS
100% energy density and 100% portion size
|
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%).
|
|
Experimental: Std ED and Inc PS
100% energy density and 133% portion size
|
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%).
|
|
Experimental: Inc ED and Inc PS
133% energy density and 133% portion size
|
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%).
|
|
Experimental: Inc ED and Std PS
133% energy density and 100% portion size
|
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%).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Energy intake
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Food intake
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
November 14, 2012
First Submitted That Met QC Criteria
November 14, 2012
First Posted (Estimate)
November 20, 2012
Study Record Updates
Last Update Posted (Estimate)
November 20, 2012
Last Update Submitted That Met QC Criteria
November 14, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FoodED501
- 5R01DK059853-11 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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