- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01653886
Palatability (Energy I Pilot)
February 3, 2016 updated by: Corby K. Martin, Pennington Biomedical Research Center
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
16
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
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
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
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Pilot Group 1
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).
|
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.
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.
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.
|
EXPERIMENTAL: Pilot Group 2
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).
|
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.
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.
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.
|
EXPERIMENTAL: Pilot Group 3
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).
|
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.
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.
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.
|
EXPERIMENTAL: Pilot Group 4
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).
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
October 1, 2010
Primary Completion (ACTUAL)
February 1, 2011
Study Completion (ACTUAL)
April 1, 2011
Study Registration Dates
First Submitted
July 26, 2012
First Submitted That Met QC Criteria
July 30, 2012
First Posted (ESTIMATE)
July 31, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
February 4, 2016
Last Update Submitted That Met QC Criteria
February 3, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PBRC 10017-P
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.
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