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Completed

NCT Number: NCT01653886

Palatability (Energy I Pilot)

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 31, 2012
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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