Palatability (Energy I Pilot)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corby K. Martin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01653886
First received: July 26, 2012
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Energy Density
Other: Breakfast (1-2 hours, in the morning)
Other: Lunch (1-2 Hours, at midday)
Other: Dinner (1-2 hours, in the afternoon)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Palatability [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pilot Group
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).
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.
Other: 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: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653886

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corby K. Martin, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01653886     History of Changes
Other Study ID Numbers: PBRC10017-P
Study First Received: July 26, 2012
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Palatability
Taste

ClinicalTrials.gov processed this record on August 01, 2014