Energy DensityNCT01653886
Palatability (Energy I Pilot)
A study testing Breakfast (1-2 hours, in the morning), Lunch (1-2 Hours, at midday) and Dinner (1-2 hours, in the afternoon) in people with Energy Density, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
A pilot study was conducted to develop the study menus that were similar in appearance, aroma, and taste. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Density
- What is being tested?
- Breakfast (1-2 hours, in the morning), Lunch (1-2 Hours, at midday) and Dinner (1-2 hours, in the afternoon)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- You are between the ages of 18 and 50, inclusive, if you are a male or between the ages of 18 and 45, inclusive, if you are a female.
- your body mass index (BMI) is between 25 and 30 kg/m2, inclusive
- For females, if you have regular menstrual periods, with no less than 28 day cycles.
Who cannot join
- you have a chronic disease that affects body weight, appetite, or metabolism, such as diabetes and cardiovascular disease.
- You use prescriptions or over-the-counter medications or herbal products that affect metabolism or body weight (e.g. weight loss medications such as sibutramine, or orlistat).
- You have symptoms of depression or excessive dietary restraint.
- You have an allergy to one or more of the test foods.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Palatability of Meals That Vary in Fat and Energy Density. A Pilot Study to the Behavioral Response to Short-Term (Two Day) Positive Energy Balance Through Overfeeding (ENERGY I)
A pilot study was conducted to develop the study menus that were similar in appearance, aroma, and taste.
Read the detailed description
The aim of the pilot study was to test for differences in palatability ratings of the four menus that will be administered during the ENERGY I project. During the pilot study, palatability ratings were collected for each meal (breakfast, lunch, and dinner) from four different menus that were served to participants during the main ENERGY I trial. The menus consist of three diets that vary in dietary fat and energy density: 1) high fat/high energy density, 2) high fat/low energy density, and 3) high carbohydrate/low energy density. In addition to these three menus, the menu from the baseline period of the trial will also be tested for palatability.
- Conditions
- Energy Density
- Being tested
- Breakfast (1-2 hours, in the morning), Lunch (1-2 Hours, at midday), Dinner (1-2 hours, in the afternoon)
- Keywords
- Palatability, Taste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast (1-2 hours, in the morning)Other
You will be required to taste small portions (1 to 2 bites) of 4 different breakfast meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy density is the ammount of enregy of kilocalories in one gram of the food.
Lunch (1-2 Hours, at midday)Other
You will be required to taste small portions of 4 different lunch meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy densityis the ammount of enregy of kilocalories in one gram of the food.
Dinner (1-2 hours, in the afternoon)Other
You will be required to taste small portions of 4 different dinner meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy densityis the ammount of enregy of kilocalories in one gram of the food.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Group 1 | Experimental | Each Participant completed taste tests at breakfast, lunch and dinner consisting of the 4 menus (baseline, high fat-high energy density, high fat-low energy density, and high carbohydrate-low energy density). Receives: Other: Breakfast (1-2 hours, in the morning); Other: Lunch (1-2 Hours, at midday); Other: Dinner (1-2 hours, in the afternoon) |
| Pilot Group 2 | Experimental | Each Participant completed taste tests at breakfast, lunch and dinner consisting of the 4 menus (baseline, high fat-high energy density, high fat-low energy density, and high carbohydrate-low energy density). Receives: Other: Breakfast (1-2 hours, in the morning); Other: Lunch (1-2 Hours, at midday); Other: Dinner (1-2 hours, in the afternoon) |
| Pilot Group 3 | Experimental | Each Participant completed taste tests at breakfast, lunch and dinner consisting of the 4 menus (baseline, high fat-high energy density, high fat-low energy density, and high carbohydrate-low energy density). Receives: Other: Breakfast (1-2 hours, in the morning); Other: Lunch (1-2 Hours, at midday); Other: Dinner (1-2 hours, in the afternoon) |
| Pilot Group 4 | Experimental | Each Participant completed taste tests at breakfast, lunch and dinner consisting of the 4 menus (baseline, high fat-high energy density, high fat-low energy density, and high carbohydrate-low energy density). Receives: Other: Breakfast (1-2 hours, in the morning); Other: Lunch (1-2 Hours, at midday); Other: Dinner (1-2 hours, in the afternoon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatability
The aim of the study is to test for differences in palatability rats of four menus that will be administered during the ENERGY I project. During the pilot study, weill will collect palatability ratings for each menu (breakfast, lunch, and dinner) from four different menus that will be served to participants during the main trial. The menus consist of three diets and baseline. that vary in dietary fat and energy density : 1) high fat/high energy density, 2) hgih fat/low energy density, and 3) high carbohydrate/low energy density.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionApr 2011
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 Energy DensityStudies of the same condition, open and under way.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corby K. Martin, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653886
- Sponsor's protocol ID
- PBRC 10017-P
- Status last verified
- Feb 2016
- First submitted
- 26 Jul 2012
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Apolzan JW, Bray GA, Hamilton MT, Zderic TW, Han H, Champagne CM, Shepard D, Martin CK. Short-term overeating results in incomplete energy intake compensation regardless of energy density or macronutrient composition. Obesity (Silver Spring). 2014 Jan;22(1):119-30. doi: 10.1002/oby.20587. Epub 2013 Sep 10.
PubMed 23913807
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatability of Meals That Vary in Fat and Energy Density. A Pilot Study to the Behavioral Response to Short-Term (Two Day) Positive Energy Balance Through Overfeeding (ENERGY I)
- ClinicalTrials.gov ID
- NCT01653886
- Acronym / sponsor ID
- PBRC 10017-P
- Conditions
- Energy Density
- Keywords
- Palatability, Taste
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 31 Jul 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.
A pilot study was conducted to develop the study menus that were similar in appearance, aroma, and taste.
Detailed description
The aim of the pilot study was to test for differences in palatability ratings of the four menus that will be administered during the ENERGY I project. During the pilot study, palatability ratings were collected for each meal (breakfast, lunch, and dinner) from four different menus that were served to participants during the main ENERGY I trial. The menus consist of three diets that vary in dietary fat and energy density: 1) high fat/high energy density, 2) high fat/low energy density, and 3) high carbohydrate/low energy density. In addition to these three menus, the menu from the baseline period of the trial will also be tested for palatability.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pilot Group 1 | Experimental | Other: Breakfast (1-2 hours, in the morning), Other: Lunch (1-2 Hours, at midday), Other: Dinner (1-2 hours, in the afternoon)Each Participant completed taste tests at breakfast, lunch and dinner consisting of the 4 menus (baseline, high fat-high energy density, high fat-low energy density, and high carbohydrate-low energy density). |
| Pilot Group 2 | Experimental | Other: Breakfast (1-2 hours, in the morning), Other: Lunch (1-2 Hours, at midday), Other: Dinner (1-2 hours, in the afternoon)Each Participant completed taste tests at breakfast, lunch and dinner consisting of the 4 menus (baseline, high fat-high energy density, high fat-low energy density, and high carbohydrate-low energy density). |
| Pilot Group 3 | Experimental | Other: Breakfast (1-2 hours, in the morning), Other: Lunch (1-2 Hours, at midday), Other: Dinner (1-2 hours, in the afternoon)Each Participant completed taste tests at breakfast, lunch and dinner consisting of the 4 menus (baseline, high fat-high energy density, high fat-low energy density, and high carbohydrate-low energy density). |
| Pilot Group 4 | Experimental | Other: Breakfast (1-2 hours, in the morning), Other: Lunch (1-2 Hours, at midday), Other: Dinner (1-2 hours, in the afternoon)Each Participant completed taste tests at breakfast, lunch and dinner consisting of the 4 menus (baseline, high fat-high energy density, high fat-low energy density, and high carbohydrate-low energy density). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- You are between the ages of 18 and 50, inclusive, if you are a male or between the ages of 18 and 45, inclusive, if you are a female.
- your body mass index (BMI) is between 25 and 30 kg/m2, inclusive
- For females, if you have regular menstrual periods, with no less than 28 day cycles.
Key exclusion criteria (4 listed)
- you have a chronic disease that affects body weight, appetite, or metabolism, such as diabetes and cardiovascular disease.
- You use prescriptions or over-the-counter medications or herbal products that affect metabolism or body weight (e.g. weight loss medications such as sibutramine, or orlistat).
- You have symptoms of depression or excessive dietary restraint.
- You have an allergy to one or more of the test foods.
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 |
|---|---|---|
| Breakfast (1-2 hours, in the morning)You will be required to taste small portions (1 to 2 bites) of 4 different breakfast meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy density is the ammount of enregy of kilocalories in one gram of the food. | Other | Pilot Group 1, Pilot Group 2, Pilot Group 3, Pilot Group 4 |
| Lunch (1-2 Hours, at midday)You will be required to taste small portions of 4 different lunch meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy densityis the ammount of enregy of kilocalories in one gram of the food. | Other | Pilot Group 1, Pilot Group 2, Pilot Group 3, Pilot Group 4 |
| Dinner (1-2 hours, in the afternoon)You will be required to taste small portions of 4 different dinner meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy densityis the ammount of enregy of kilocalories in one gram of the food. | Other | Pilot Group 1, Pilot Group 2, Pilot Group 3, Pilot Group 4 |
Primary outcome
Palatability
Time frame: 2 days
The aim of the study is to test for differences in palatability rats of four menus that will be administered during the ENERGY I project. During the pilot study, weill will collect palatability ratings for each menu (breakfast, lunch, and dinner) from four different menus that will be served to participants during the main trial. The menus consist of three diets and baseline. that vary in dietary fat and energy density : 1) high fat/high energy density, 2) hgih fat/low energy density, and 3) high carbohydrate/low energy density.
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 4 Feb 2016.
- Derived from this study: PubMed 23913807Apolzan JW, Bray GA, Hamilton MT, Zderic TW, Han H, Champagne CM, Shepard D, Martin CK. Short-term overeating results in incomplete energy intake compensation regardless of energy density or macronutrient composition. Obesity (Silver Spring). 2014 Jan;22(1):119-30. doi: 10.1002/oby.20587. Epub 2013 Sep 10.
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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 Breakfast (1-2 hours, in the morning), Lunch (1-2 Hours, at midday) and Dinner (1-2 hours, in the afternoon) in people with Energy Density, run by Pennington Biomedical Research Center 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 3 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 4 Feb 2016. 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?
Palatability (time frame: 2 days). 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 NCT01653886, 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 4 Feb 2016.