ObesityNCT01165086
Reducing Dietary Energy Density by Incorporating Vegetables in Order to Decrease Energy Intake
A study testing Incorporating vegetables into the diet to reduce energy density in people with Obesity, run by Penn State University at 1 site in United States.
Trial summary
This study will test the hypothesis that incorporating vegetables into meals as a method of reducing the energy density will result in increased vegetable intake and decreased energy intake. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Incorporating vegetables into the diet to reduce energy density
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2010
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 20-45 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
This study will test the hypothesis that incorporating vegetables into meals as a method of reducing the energy density will result in increased vegetable intake and decreased energy intake.
- Conditions
- Obesity
- Being tested
- Incorporating vegetables into the diet to reduce energy density
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incorporating vegetables into the diet to reduce energy densityOther
The entree portion of breakfast, lunch, and dinner meals will be manipulated to be a standard energy density, a 15% reduction in energy density, or a 25% reduction in energy density.
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Measured: 3 weeks
Secondary outcomes (1)
Vegetable intake
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 48 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
- NCT01165086
- Sponsor's protocol ID
- FoodED101
- Other IDs
- R37DK039177, R01DK059853
- Status last verified
- Nov 2011
- First submitted
- 16 Jul 2010
- Last updated
- 10 Nov 2011
- Results posted
- No
Publications
Blatt AD, Roe LS, Rolls BJ. Hidden vegetables: an effective strategy to reduce energy intake and increase vegetable intake in adults. Am J Clin Nutr. 2011 Apr;93(4):756-63. doi: 10.3945/ajcn.110.009332. Epub 2011 Feb 2.
PubMed 21289225
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Dietary Energy Density by Incorporating Vegetables in Order to Decrease Energy Intake
- ClinicalTrials.gov ID
- NCT01165086
- Acronym / sponsor ID
- FoodED101
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Jul 2010 (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.
This study will test the hypothesis that incorporating vegetables into meals as a method of reducing the energy density will result in increased vegetable intake and decreased energy intake.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults aged 20-45 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Incorporating vegetables into the diet to reduce energy densityThe entree portion of breakfast, lunch, and dinner meals will be manipulated to be a standard energy density, a 15% reduction in energy density, or a 25% reduction in energy density. | Other | – |
Primary outcome
Energy intake
Time frame: 3 weeks
1 secondary outcome
Vegetable intake
Time frame: 3 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 10 Nov 2011.
- Derived from this study: PubMed 21289225Blatt AD, Roe LS, Rolls BJ. Hidden vegetables: an effective strategy to reduce energy intake and increase vegetable intake in adults. Am J Clin Nutr. 2011 Apr;93(4):756-63. doi: 10.3945/ajcn.110.009332. Epub 2011 Feb 2.
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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 Incorporating vegetables into the diet to reduce energy density 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 0 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 10 Nov 2011. 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: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01165086, which also lists 1 linked publication.
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 10 Nov 2011.