- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05266183
Combined Effects of Simultaneous Variety and Portion Size on Meal Intake of Women
October 7, 2022 updated by: Barbara J. Rolls, Penn State University
The primary purpose of this study is to investigate the combined effects of simultaneous meal variety and portion size on food intake at a meal.
Additionally, other individual characteristics will be examined for their influence on the effects of simultaneous variety and portion size on meal intake.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
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
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University Park, Pennsylvania, United States, 16802
- Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
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-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Be willing and able to travel to Penn State University Park campus weekly for meals
- Be fully vaccinated against COVID-19
- Be a woman 20 - 65 years old
- Regularly eat 3 meals/day
- Be willing to refrain from drinking 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
- Must not have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
- Must not dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
- Must not have a high variability in liking of the test foods
- Must not be currently dieting to gain or lose weight
- Must not have a health condition that affects appetite
- Must not 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: Simultaneous Variety, Small Portion
3 different foods served in a small portion.
|
Small meal portion size
3 different foods served
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Experimental: Simultaneous Variety, Large Portion
3 different foods served in a large portion.
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Large meal portion size
3 different foods served
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Experimental: Single-Food, Small Portion
1 food served in a small portion.
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Small meal portion size
1 food served
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Experimental: Single-Food, Large Portion
1 food served in a large portion.
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Large meal portion size
1 food served
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in intake by weight
Time Frame: Weeks 1, 2, 3, 4
|
Weight (grams) of all meal components consumed
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Weeks 1, 2, 3, 4
|
Change in energy intake
Time Frame: Weeks 1, 2, 3, 4
|
Energy intake (kilocalories) of all meal components consumed, calculated from weight and energy density
|
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 food during the meal
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Weeks 1, 2, 3, 4
|
Change in mean eating rate
Time Frame: Weeks 1, 2, 3, 4
|
Mean food intake per minute (grams/minute), calculated by dividing meal food intake by meal duration
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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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Mean food intake per bite (grams/bite), calculated by dividing meal food intake by bite count
|
Weeks 1, 2, 3, 4
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Change in sip count
Time Frame: Weeks 1, 2, 3, 4
|
The number of sips of water during the meal
|
Weeks 1, 2, 3, 4
|
Change in mean drinking rate
Time Frame: Weeks 1, 2, 3, 4
|
Mean water intake per minute (grams/minute), calculated by dividing meal water intake by meal duration
|
Weeks 1, 2, 3, 4
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Change in mean sip size
Time Frame: Weeks 1, 2, 3, 4
|
Mean water intake per sip (grams/sip), calculated by dividing meal water intake by sip count
|
Weeks 1, 2, 3, 4
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Change in switching between bites and sips
Time Frame: Weeks 1, 2, 3, 4
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The number of switches between bites and sips during the meal
|
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)
|
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
|
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
|
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
|
Change in meal duration
Time Frame: Weeks 1, 2, 3, 4
|
Duration of the meal in minutes
|
Weeks 1, 2, 3, 4
|
Change in switching between different foods
Time Frame: Weeks 1, 2, 3, 4
|
The number of switches between different foods
|
Weeks 1, 2, 3, 4
|
Change in rating of 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
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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 desire to eat food samples
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 strong (0 mm) to extremely strong (100 mm), in answer to "How strong is your desire to eat [this food] 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
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Change in rating of nausea
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 nauseated (0 mm) to extremely nauseated (100 mm)
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Change in rating of prospective consumption
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 nothing at all (0 mm) to a large amount (100 mm), in answer to "How much food do you think you could eat right now?".
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
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)
March 7, 2022
Primary Completion (Actual)
September 21, 2022
Study Completion (Actual)
September 21, 2022
Study Registration Dates
First Submitted
February 23, 2022
First Submitted That Met QC Criteria
February 23, 2022
First Posted (Actual)
March 4, 2022
Study Record Updates
Last Update Posted (Actual)
October 10, 2022
Last Update Submitted That Met QC Criteria
October 7, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- FoodVariety103
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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