- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404998
The Influence of Energy Density and Information on Meal Intake in Adults
December 8, 2021 updated by: Barbara J. Rolls, Penn State University
Lunch Meal Study for Men and Women
The purpose of this study is to gain a better understanding of how energy density and cognitive framing of satiation using food information can influence consumption at a meal.
This study also aims to investigate the influence of energy density and food information on sensory specific satiety (the decline in the subjective pleasantness of a food as it is eaten).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
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
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
-
-
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
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ability to attend all test meals
- Be fully vaccinated against COVID-19
- Regularly eat 3 meals/day
- Being willing to avoid alcohol the day before and during test days
- Have a body mass index greater than 18.0 kg/meters squared
- Being willing to refrain from eating after 10 pm the evening before test sessions
Exclusion Criteria:
- Being a smoker
- Being an athlete in training
- Being pregnant or breastfeeding at the time of screening
- Have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
- Dislike or inability to eat the test foods
- Currently dieting to gain or lose weight
- Have a health condition that affects appetite
- Have participated in a similar study in our lab in the past year
- Being a student, faculty, or staff member in nutritional sciences or psychology
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lower Energy Density & Lower Satiation
Test meal with lower energy density and lower satiation information
|
Test meal with lower energy density
Information on lower satiation
|
|
Experimental: Lower Energy Density & Higher Satiation
Test meal with lower energy density and higher satiation information
|
Test meal with lower energy density
Information on higher satiation
|
|
Experimental: Higher Energy Density & Lower Satiation
Test meal with higher energy density and lower satiation information
|
Information on lower satiation
Test meal with higher energy density
|
|
Experimental: Higher Energy Density & Higher Satiation
Test meal with higher energy density and higher satiation information
|
Information on higher satiation
Test meal with higher energy density
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in food intake by weight
Time Frame: Weeks 1, 2, 3, 4
|
Weight of food consumed measured in grams (g)
|
Weeks 1, 2, 3, 4
|
|
Change in energy intake
Time Frame: Weeks 1, 2, 3, 4
|
Energy content of food consumed measured in kilocalories (kcal)
|
Weeks 1, 2, 3, 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in palatability rating of food samples
Time Frame: Weeks 1, 2, 3, 4
|
Difference between post-meal and pre-meal palatability of the food samples measured by Visual Analogue Scales (ranging from 0 mm to 100 mm) to assess Sensory-Specific Satiety
|
Weeks 1, 2, 3, 4
|
|
Change in prospective consumption rating of food samples
Time Frame: Weeks 1, 2, 3, 4
|
Difference between post-meal and pre-meal prospective consumption of food samples measured by Visual Analogue Scales (ranging from 0 mm to 100 mm) to assess Sensory-Specific Satiety
|
Weeks 1, 2, 3, 4
|
|
Change in hunger rating
Time Frame: Weeks 1, 2, 3, 4
|
Difference between post-meal and pre-meal hunger measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
|
Weeks 1, 2, 3, 4
|
|
Change in fullness rating
Time Frame: Weeks 1, 2, 3, 4
|
Difference between post-meal and pre-meal fullness measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
|
Weeks 1, 2, 3, 4
|
|
Change in test meal prospective consumption rating
Time Frame: Weeks 1, 2, 3, 4
|
Difference in prospective consumption measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
|
Weeks 1, 2, 3, 4
|
|
Change in test meal fillingness rating
Time Frame: Weeks 1, 2, 3, 4
|
Difference in fillingness measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
|
Weeks 1, 2, 3, 4
|
|
Change in test meal palatability rating
Time Frame: Weeks 1, 2, 3, 4
|
Difference in palatability of the test meal measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
|
Weeks 1, 2, 3, 4
|
|
Change in estimation of proportion of test meal consumed
Time Frame: Weeks 1, 2, 3, 4
|
Difference in estimation of proportion of test meal consumed measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
|
Weeks 1, 2, 3, 4
|
|
Change in estimation of energy content of test meal consumed
Time Frame: Weeks 1, 2, 3, 4
|
Difference in estimation of energy content of test meal consumed measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
|
Weeks 1, 2, 3, 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
August 3, 2021
Primary Completion (Actual)
November 8, 2021
Study Completion (Actual)
November 8, 2021
Study Registration Dates
First Submitted
March 11, 2020
First Submitted That Met QC Criteria
May 26, 2020
First Posted (Actual)
May 28, 2020
Study Record Updates
Last Update Posted (Actual)
December 29, 2021
Last Update Submitted That Met QC Criteria
December 8, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- FoodED601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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