ObesityNCT01729390
Varying the Energy Density and Portion Size of the Main Course After a First-course Salad
A study testing Energy density and portion size feeding study in people with Obesity, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Energy density and portion size feeding study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Nov 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults from Penn State and the surrounding community
Who cannot join
- Currently dieting
- Food allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16802
About this study
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.
- Conditions
- Obesity
- Being tested
- Energy density and portion size feeding study
- Keywords
- Feeding behavior
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy density and portion size feeding studyOther
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%).
| Study group | Role | What they receive |
|---|---|---|
| Std ED Control | Experimental | 100% energy density and 133% portion size Receives: Other: Energy density and portion size feeding study |
| Inc ED Control | Experimental | 133% energy density and 133% portion size Receives: Other: Energy density and portion size feeding study |
| Std ED and Std PS | Experimental | 100% energy density and 100% portion size Receives: Other: Energy density and portion size feeding study |
| Std ED and Inc PS | Experimental | 100% energy density and 133% portion size Receives: Other: Energy density and portion size feeding study |
| Inc ED and Inc PS | Experimental | 133% energy density and 133% portion size Receives: Other: Energy density and portion size feeding study |
| Inc ED and Std PS | Experimental | 133% energy density and 100% portion size Receives: Other: Energy density and portion size feeding study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Measured: 6 weeks
Secondary outcomes (1)
Food intake
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionNov 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 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
- Investigators
- Barbara J Rolls, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729390
- Sponsor's protocol ID
- FoodED501
- Other IDs
- 5R01DK059853-11
- Status last verified
- Nov 2012
- First submitted
- 14 Nov 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varying the Energy Density and Portion Size of the Main Course After a First-course Salad
- ClinicalTrials.gov ID
- NCT01729390
- Acronym / sponsor ID
- FoodED501
- Conditions
- Obesity
- Keywords
- Feeding behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Nov 2012 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Std ED Control | Experimental | Other: Energy density and portion size feeding study100% energy density and 133% portion size |
| Inc ED Control | Experimental | Other: Energy density and portion size feeding study133% energy density and 133% portion size |
| Std ED and Std PS | Experimental | Other: Energy density and portion size feeding study100% energy density and 100% portion size |
| Std ED and Inc PS | Experimental | Other: Energy density and portion size feeding study100% energy density and 133% portion size |
| Inc ED and Inc PS | Experimental | Other: Energy density and portion size feeding study133% energy density and 133% portion size |
| Inc ED and Std PS | Experimental | Other: Energy density and portion size feeding study133% energy density and 100% portion size |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults from Penn State and the surrounding community
Key exclusion criteria (2 listed)
- Currently dieting
- Food allergies
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 and portion size feeding studyIn 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%). | Other | Inc ED Control, Inc ED and Inc PS, Inc ED and Std PS, Std ED Control, Std ED and Inc PS, Std ED and Std PS |
Primary outcome
Energy intake
Time frame: 6 weeks
1 secondary outcome
Food intake
Time frame: 6 weeks
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 20 Nov 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.
Barbara J Rolls principal investigator
Penn State University
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 and portion size feeding study 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 1 inclusion and 2 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 20 Nov 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?
Energy intake (time frame: 6 weeks). 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 20 Nov 2012; AzTrials last refreshed its copy on 7 Nov 2026.