NCT01653886

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

July 26, 2012

Last Update Submit

February 3, 2016

Conditions

Keywords

PalatabilityTaste

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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).

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).

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).

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).

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

Interventions

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.

Pilot Group 1Pilot Group 2Pilot Group 3Pilot Group 4

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.

Pilot Group 1Pilot Group 2Pilot Group 3Pilot Group 4

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.

Pilot Group 1Pilot Group 2Pilot Group 3Pilot Group 4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

BreakfastLunchMeals

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2012

First Posted

July 31, 2012

Study Start

October 1, 2010

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations