- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03886428
The Influence of Satiation Measures on the Portion Size Effect
March 11, 2020 updated by: Barbara J. Rolls, Penn State University
Lunch Feeding Study for Men and Women
The purpose of this study is to gain a better understanding of the satiation measures that influence human eating behavior in regard to intake of large portion sizes at a meal.
The investigators hypothesize that satiation measures will influence the magnitude of the portion size effect at a meal.
Additionally, other individual characteristics will be examined for their influence on the portion size effect.
The portion size effect will be measured by serving a test meal once a week for four weeks in which the portion size of the entree will be varied.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
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
- 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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be willing and able to travel to Penn State University Park campus weekly for meals
- Be a man or woman 18 - 70 years old
- Regularly eat 3 meals/day
- Be willing to avoid alcohol the day before and during test days
- Have a body mass index between 18.0 and 35.0 kg/m*m
- Be willing to refrain from eating after 10 pm the evening before test sessions
- Be willing to participate in all study procedures
Exclusion Criteria:
- Must not be a smoker
- Must not be an athlete in training
- Must not be 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 be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
- Must not be 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
- Must not be 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: 100% Portion Size
Test meal with portion size 100% of baseline
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Entree portion size 100% of baseline
|
Experimental: 125% Portion Size
Test meal with portion size 125% of baseline
|
Entree portion size 125% of baseline
|
Experimental: 150% Portion Size
Test meal with portion size 150% of baseline
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Entree portion size 150% of baseline
|
Experimental: 175% Portion Size
Test meal with portion size 175% of baseline
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Entree portion size 175% of baseline
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in energy intake
Time Frame: Weeks 1, 2, 3, 4
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Calculated energy intake (kcal) based on weight and energy density of food consumed
|
Weeks 1, 2, 3, 4
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Change in intake by weight
Time Frame: Weeks 1, 2, 3, 4
|
Weights (grams) of all foods consumed
|
Weeks 1, 2, 3, 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bite count
Time Frame: Weeks 1, 2, 3, 4
|
The number of bites of the entree during the meal
|
Weeks 1, 2, 3, 4
|
Change in meal duration
Time Frame: Weeks 1, 2, 3, 4
|
Duration of the meal in seconds
|
Weeks 1, 2, 3, 4
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Change in mean bite rate
Time Frame: Weeks 1, 2, 3, 4
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Assessed from meal duration (seconds) and number of bites taken
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Weeks 1, 2, 3, 4
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Change in mean bite size
Time Frame: Weeks 1, 2, 3, 4
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Assessed from entree intake (grams) and number of bites
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Weeks 1, 2, 3, 4
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Change in mean eating rate
Time Frame: Weeks 1, 2, 3, 4
|
Assessed from entree intake (grams) and meal duration
|
Weeks 1, 2, 3, 4
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Change in distribution of estimated bite size
Time Frame: Weeks 1, 2, 3, 4
|
Assessed as small or large bites from video observation
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Weeks 1, 2, 3, 4
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Change in sip count
Time Frame: Weeks 1, 2, 3, 4
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The number of sips of the water during the meal
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Weeks 1, 2, 3, 4
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Change in rating of the pleasantness of the taste of the entree sample
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Measured on a 100-mm visual analogue scale ranging from not at all pleasant (0 mm) to extremely pleasant (100 mm).
This will be used to calculate Sensory-Specific Satiety
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Change in rating of the pleasantness of the taste of food samples
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Measured on a 100-mm visual analogue scale ranging from not at all pleasant (0 mm) to extremely pleasant (100 mm).
This will be used to calculate Sensory-Specific Satiety
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Change in rating of prospective consumption of the entree sample
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Measured on a 100-mm visual analogue scale ranging from none at all (0 mm) to vary large amount (100 mm) in answer to the question 'How much of the pasta do you want to eat right now?'.
This will be used to calculate Sensory-Specific Satiety
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Change in rating of prospective consumption of food samples
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Measured on a 100-mm visual analogue scale ranging from none at all (0 mm) to vary large amount (100 mm) how much of the [this food] do you want to eat right now?.
This will be used to calculate Sensory-Specific Satiety
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Change in rating of hunger
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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Measured on a 100-mm visual analogue scale ranging from not at all hungry (0 mm) to extremely hungry (100 mm)
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From before the test meal to after the test meal in weeks 1, 2, 3, 4
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Change in rating of thirst
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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Measured on a 100-mm visual analogue scale ranging from not at all thirsty (0 mm) to extremely thirsty (100 mm)
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
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Change in ratings of prospective consumption
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Measured on a 100-mm visual analogue scale ranging from nothing at all (0 mm) to a large amount (100 mm) in answer to the question 'How much food could you eat right now?'.
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From before the test meal to after the test meal in weeks 1, 2, 3, 4
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Change in ratings of nausea
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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Measured on a 100-mm visual analogue scale ranging from not at all nauseated (0 mm) to extremely nauseated (100 mm)
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From before the test meal to after the test meal in weeks 1, 2, 3, 4
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Change in rating of fullness
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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Measured on a 100-mm visual analogue scale ranging from not at all full (0 mm) to extremely full (100 mm)
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rating of the size of the entree compared to participants' usual portion
Time Frame: At the start of the test meal in weeks 1, 2, 3, 4
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100-point visual analog scale ranging from a lot smaller to a lot larger
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At the start of the test meal in weeks 1, 2, 3, 4
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Rating of how filling participants expect this amount of food to be
Time Frame: At the start of the test meal in weeks 1, 2, 3, 4
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100-point visual analog scale ranging from not at all filling to extremely filling
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At the start of the test meal in weeks 1, 2, 3, 4
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Rating of pleasantness of taste of entree
Time Frame: At the start of the test meal in weeks 1, 2, 3, 4
|
100-point visual analog scale ranging from not pleasant at all to extremely pleasant
|
At the start of the test meal in weeks 1, 2, 3, 4
|
Ratings of Meal Termination due to fullness
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
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100-point visual analog scale ranging from strongly disagree to strongly agree
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At the end of the test meal in weeks 1, 2, 3, 4
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Ratings of Meal Termination due to eating their usual amount
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
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100-point visual analog scale ranging from strongly disagree to strongly agree
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At the end of the test meal in weeks 1, 2, 3, 4
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Ratings of Meal Termination due to eating is no longer a priority
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
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100-point visual analog scale ranging from strongly disagree to strongly agree
|
At the end of the test meal in weeks 1, 2, 3, 4
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Ratings of Meal Termination due to there being no food left
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
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100-point visual analog scale ranging from strongly disagree to strongly agree
|
At the end of the test meal in weeks 1, 2, 3, 4
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Ratings of Meal Termination due to self-consciousness about amount consumed
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
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100-point visual analog scale ranging from strongly disagree to strongly agree
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At the end of the test meal in weeks 1, 2, 3, 4
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Ratings of Meal Termination due to the food no longer tasting good
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
|
100-point visual analog scale ranging from strongly disagree to strongly agree
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At the end of the test meal in weeks 1, 2, 3, 4
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Rating of proportion of meal eaten
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
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100-point visual analog scale ranging from 0% to 100%
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At the end of the test meal in weeks 1, 2, 3, 4
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Rating of calories consumed at the meal
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
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Open ended question
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At the end of the test meal in weeks 1, 2, 3, 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
May 21, 2019
Primary Completion (Actual)
December 11, 2019
Study Completion (Actual)
December 13, 2019
Study Registration Dates
First Submitted
March 14, 2019
First Submitted That Met QC Criteria
March 19, 2019
First Posted (Actual)
March 22, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2020
Last Update Submitted That Met QC Criteria
March 11, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- PortionSize106
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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