Palatability (Energy I Pilot)

Energy Density Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653886
• Other study ID #: PBRC 10017-P
• Status: Completed
• Phase: N/A
• First received: July 26, 2012
• Last updated: February 3, 2016
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: February 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A pilot study was conducted to develop the study menus that were similar in appearance, aroma, and taste.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Energy Density

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 days	No