ObesityEDENNCT01349023
Energy Content and Energy Density of Pre-portioned Entrees
A study testing Energy density (ED), Energy content in people with Obesity, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Energy density (ED), Energy content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Effects of Energy Density and Energy Content of Pre-portioned entrées on Energy Intake
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.
Read the 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
- Being tested
- Energy density (ED), Energy content
- Keywords
- energy content, energy density, energy intake, pre-portioned entrees
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy density (ED), Energy contentOther
Standard or reduced energy content and energy density of pre-portioned entrees
| Study group | Role | What they receive |
|---|---|---|
| Standard Energy content/Standard ED | Experimental | Not described Receives: Other: Energy density (ED), Energy content |
| Standard Energy content/Reduced ED | Experimental | Not described Receives: Other: Energy density (ED), Energy content |
| Reduced Energy content/Standard ED | Experimental | Not described Receives: Other: Energy density (ED), Energy content |
| Reduced Energy content/Reduced ED | Experimental | Not described Receives: Other: Energy density (ED), Energy content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Energy Intake (kcal/day)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara J. Rolls, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349023
- Sponsor's protocol ID
- FoodED301
- Other IDs
- R01DK059853, R37DK039177
- Acronym
- EDEN
- Status last verified
- Mar 2012
- First submitted
- 3 May 2011
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Energy Density and Energy Content of Pre-portioned entrées on Energy Intake
- ClinicalTrials.gov ID
- NCT01349023
- Acronym / sponsor ID
- EDEN / FoodED301
- Conditions
- Obesity
- Keywords
- energy content, energy density, energy intake, pre-portioned entrees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy density (ED), Energy contentStandard or reduced energy content and energy density of pre-portioned entrees | Other | Reduced Energy content/Reduced ED, Reduced Energy content/Standard ED, Standard Energy content/Reduced ED, Standard Energy content/Standard ED |
Primary outcome
Daily Energy Intake (kcal/day)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy density (ED), Energy content in people with Obesity, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Energy Intake (kcal/day) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2012.