- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01470300
Reducing Energy Density by Different Methods to Decrease Energy Intake
November 10, 2011 updated by: Barbara J. Rolls, Penn State University
The purpose of this research is to investigate how using different methods to reduce the energy density of entrees affects daily energy intake in adults.
It is hypothesized that reducing the energy density of entrees will decrease energy intake.
It is also hypothesized that reducing the energy density by incorporating fruit and vegetables will decrease energy intake more than reducing the energy density by decreasing fat content or adding plain water.
Study Overview
Study Type
Interventional
Enrollment (Actual)
62
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
-
-
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
All
Description
Inclusion Criteria:
- Adults from Penn State and 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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Standard ED
100% energy density
|
In a crossover design, adults are served breakfast, lunch, and dinner, 1 day a week for 4 weeks.
Meal entrees will vary in energy density (100% and 80%) and the method used to reduce the energy density (added fruit & vegetables, decreased fat, added plain water).
|
|
EXPERIMENTAL: Reduced ED - F/V
80% energy density by adding fruit and vegetables
|
In a crossover design, adults are served breakfast, lunch, and dinner, 1 day a week for 4 weeks.
Meal entrees will vary in energy density (100% and 80%) and the method used to reduce the energy density (added fruit & vegetables, decreased fat, added plain water).
|
|
EXPERIMENTAL: Reduced ED - Fat
80% energy density by decreasing fat
|
In a crossover design, adults are served breakfast, lunch, and dinner, 1 day a week for 4 weeks.
Meal entrees will vary in energy density (100% and 80%) and the method used to reduce the energy density (added fruit & vegetables, decreased fat, added plain water).
|
|
EXPERIMENTAL: Reduced ED - Plain water
80% energy density by adding plain water
|
In a crossover design, adults are served breakfast, lunch, and dinner, 1 day a week for 4 weeks.
Meal entrees will vary in energy density (100% and 80%) and the method used to reduce the energy density (added fruit & vegetables, decreased fat, added plain water).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Energy intake
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Food intake
Time Frame: 1 month
|
1 month
|
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)
May 1, 2011
Study Completion (ACTUAL)
May 1, 2011
Study Registration Dates
First Submitted
November 9, 2011
First Submitted That Met QC Criteria
November 10, 2011
First Posted (ESTIMATE)
November 11, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 11, 2011
Last Update Submitted That Met QC Criteria
November 10, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- FoodED401
- R37DK039177-19 (NIH)
- 2R01DK059853-10 (NIH)
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.