Eating BehaviorNCT05152693
Effects of Variety and Portion Size on Meal Intake of Adults
A study testing Low variety, High Variety and Small Portion Size in people with Eating Behavior, run by Penn State University at 1 site in United States.
Trial summary
The primary purpose of this study is to gain a better understanding of the combined effects of meal variety and portion size on food intake at a meal. The study will also explore relationships with eating microstructure such as eating rate and bite size. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Low variety, High Variety and Small Portion Size
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 27 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 be currently dieting to gain or lose weight
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
The primary purpose of this study is to gain a better understanding of the combined effects of meal variety and portion size on food intake at a meal. The study will also explore relationships with eating microstructure such as eating rate and bite size. Additionally, other individual characteristics will be examined for their influence on the effects of variety and portion size on meal intake.
- Conditions
- Eating Behavior
- Being tested
- Low variety, High Variety, Small Portion Size, Large Portion Size, With Beverage
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low varietyOther
Meal components are mixed together on the plate
High VarietyOther
Meal components are served separately on the plate
Small Portion SizeOther
Small meal portion size
Large Portion SizeOther
Large meal portion size
With BeverageOther
Meal served with water
Without BeverageOther
Meal served without water
| Study group | Role | What they receive |
|---|---|---|
| Low Variety Small Portion Without Beverage | Experimental | Test meal with food components mixed together (low variety) with a small portion of food served without water Receives: Other: Low variety; Other: Small Portion Size; Other: Without Beverage |
| High Variety Small Portion Without Beverage | Experimental | Test meal with food components separated on the plate (high variety) with a small portion of food served without water Receives: Other: High Variety; Other: Small Portion Size; Other: Without Beverage |
| Low Variety Small Portion With Beverage | Experimental | Test meal with food components mixed together (low variety) with a small portion of food and water Receives: Other: Low variety; Other: Small Portion Size; Other: With Beverage |
| High Variety Small Portion With Beverage | Experimental | Test meal with food components separated on the plate (high variety) with a small portion of food and water Receives: Other: High Variety; Other: Small Portion Size; Other: With Beverage |
| Low Variety Large Portion With Beverage | Experimental | Test meal with food components mixed together (low variety) with a large portion of food and water Receives: Other: Low variety; Other: Large Portion Size; Other: With Beverage |
| High Variety Large Portion With Beverage | Experimental | Test meal with food components separated on the plate (high variety) with a large portion of food and water Receives: Other: High Variety; Other: Large Portion Size; Other: With Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intake by weight
Weight (grams) of all meal components consumed
Measured: Weeks 1, 2, 3, 4, 5, 6
Change in energy intake
Energy intake (kilocalories) of all meal components consumed, calculated from weight and energy density
Measured: Weeks 1, 2, 3, 4, 5, 6
Secondary outcomes (25)
Change in bite count
The number of bites of food during the meal
Measured: Weeks 1, 2, 3, 4, 5, 6
Change in meal duration
Duration of the meal in minutes
Measured: Weeks 1, 2, 3, 4, 5, 6
Change in mean eating rate
Mean food intake per minute (grams/minute), calculated by dividing meal food intake by meal duration
Measured: Weeks 1, 2, 3, 4, 5, 6
Change in mean bite size
Mean food intake per bite (grams/bite), calculated by dividing meal food intake by bite count
Measured: Weeks 1, 2, 3, 4, 5, 6
Change in sip count
The number of sips of water during the meal
Measured: Weeks 1, 2, 3, 4, 5, 6
Change in mean drinking rate
Mean water intake per minute (grams/minute), calculated by dividing meal water intake by meal duration
Measured: Weeks 1, 2, 3, 4, 5, 6
Change in mean sip size
Mean water intake per sip (grams/sip), calculated by dividing meal water intake by sip count
Measured: Weeks 1, 2, 3, 4, 5, 6
Change in switching between bites and sips
The number of switches between bites and sips during the meal
Measured: Weeks 1, 2, 3, 4, 5, 6
Change in rating of pleasantness of the taste of food samples
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
Measured: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of prospective consumption of food samples
Measured on a 100-mm visual analogue scale ranging from none at all (0 mm) to vary large amount (100 mm) how much of [this food] do you want to eat right now?. This will be used to calculate Sensory-Specific Satiety
Measured: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of hunger
Measured on a 100-mm visual analogue scale ranging from not at all hungry (0 mm) to extremely hungry (100 mm)
Measured: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of thirst
Measured on a 100-mm visual analogue scale ranging from not at all thirsty (0 mm) to extremely thirsty (100 mm)
Measured: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of nausea
Measured on a 100-mm visual analogue scale ranging from not at all nauseated (0 mm) to extremely nauseated (100 mm)
Measured: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of fullness
Measured on a 100-mm visual analogue scale ranging from not at all full (0 mm) to extremely full (100 mm)
Measured: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of prospective consumption of the meal
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?'.
Measured: At the start of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of the size of the meal compared to participant's usual portion
100-point visual analog scale ranging from a lot smaller (0 mm) to a lot larger (100 mm)
Measured: At the start of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of how filling the participant expects this amount of food to be
100-point visual analog scale ranging from not at all filling (0 mm) to extremely filling (100 mm)
Measured: At the start of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of meal termination due to fullness
100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)
Measured: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of meal termination due to eating their usual amount
100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)
Measured: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of meal termination due to eating is no longer a priority
100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)
Measured: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of meal termination due to there being no food left
100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)
Measured: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of meal termination due to self-consciousness about amount consumed
100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)
Measured: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of meal termination due to the food no longer tasting good
100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm)
Measured: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in estimation of proportion of meal eaten
100-point visual analog scale ranging from 0% to 100%
Measured: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in estimation of calories consumed at the meal
Open ended question (number of calories)
Measured: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start20 Jan 2022 (estimated)
- Primary completion20 Jan 2023 (estimated)
- Study completion27 Jan 2023 (estimated)
Why it stopped: Study design has changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Jenny Craig, Inc.
- Responsible party
- Principal investigator, Barbara J. Rolls, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152693
- Sponsor's protocol ID
- FoodVariety101
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Variety and Portion Size on Meal Intake of Adults
- ClinicalTrials.gov ID
- NCT05152693
- Acronym / sponsor ID
- FoodVariety101
- Conditions
- Eating Behavior
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design has changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Jenny Craig, Inc.
- Study start
- 20 Jan 2022 (estimated)
- Primary completion
- 20 Jan 2023 (estimated)
- Study completion
- 27 Jan 2023 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to gain a better understanding of the combined effects of meal variety and portion size on food intake at a meal. The study will also explore relationships with eating microstructure such as eating rate and bite size. Additionally, other individual characteristics will be examined for their influence on the effects of variety and portion size on meal intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low Variety Small Portion Without Beverage | Experimental | Other: Low variety, Other: Small Portion Size, Other: Without BeverageTest meal with food components mixed together (low variety) with a small portion of food served without water |
| High Variety Small Portion Without Beverage | Experimental | Other: High Variety, Other: Small Portion Size, Other: Without BeverageTest meal with food components separated on the plate (high variety) with a small portion of food served without water |
| Low Variety Small Portion With Beverage | Experimental | Other: Low variety, Other: Small Portion Size, Other: With BeverageTest meal with food components mixed together (low variety) with a small portion of food and water |
| High Variety Small Portion With Beverage | Experimental | Other: High Variety, Other: Small Portion Size, Other: With BeverageTest meal with food components separated on the plate (high variety) with a small portion of food and water |
| Low Variety Large Portion With Beverage | Experimental | Other: Low variety, Other: Large Portion Size, Other: With BeverageTest meal with food components mixed together (low variety) with a large portion of food and water |
| High Variety Large Portion With Beverage | Experimental | Other: High Variety, Other: Large Portion Size, Other: With BeverageTest meal with food components separated on the plate (high variety) with a large portion of food and water |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low varietyMeal components are mixed together on the plate | Other | Low Variety Large Portion With Beverage, Low Variety Small Portion With Beverage, Low Variety Small Portion Without Beverage |
| High VarietyMeal components are served separately on the plate | Other | High Variety Large Portion With Beverage, High Variety Small Portion With Beverage, High Variety Small Portion Without Beverage |
| Small Portion SizeSmall meal portion size | Other | High Variety Small Portion With Beverage, High Variety Small Portion Without Beverage, Low Variety Small Portion With Beverage, Low Variety Small Portion Without Beverage |
| Large Portion SizeLarge meal portion size | Other | High Variety Large Portion With Beverage, Low Variety Large Portion With Beverage |
| With BeverageMeal served with water | Other | High Variety Large Portion With Beverage, High Variety Small Portion With Beverage, Low Variety Large Portion With Beverage, Low Variety Small Portion With Beverage |
| Without BeverageMeal served without water | Other | High Variety Small Portion Without Beverage, Low Variety Small Portion Without Beverage |
Primary outcome
Change in intake by weight
Time frame: Weeks 1, 2, 3, 4, 5, 6
Weight (grams) of all meal components consumed
Change in energy intake
Time frame: Weeks 1, 2, 3, 4, 5, 6
Energy intake (kilocalories) of all meal components consumed, calculated from weight and energy density
25 secondary outcomes
Change in bite count
Time frame: Weeks 1, 2, 3, 4, 5, 6
Change in meal duration
Time frame: Weeks 1, 2, 3, 4, 5, 6
Change in mean eating rate
Time frame: Weeks 1, 2, 3, 4, 5, 6
Change in mean bite size
Time frame: Weeks 1, 2, 3, 4, 5, 6
Change in sip count
Time frame: Weeks 1, 2, 3, 4, 5, 6
Change in mean drinking rate
Time frame: Weeks 1, 2, 3, 4, 5, 6
Change in mean sip size
Time frame: Weeks 1, 2, 3, 4, 5, 6
Change in switching between bites and sips
Time frame: Weeks 1, 2, 3, 4, 5, 6
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, 5, 6
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, 5, 6
Change in rating of hunger
Time frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of thirst
Time frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of nausea
Time frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of fullness
Time frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of prospective consumption of the meal
Time frame: At the start of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of the size of the meal compared to participant's usual portion
Time frame: At the start of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of how filling the participant expects this amount of food to be
Time frame: At the start of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of meal termination due to fullness
Time frame: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating of meal termination due to eating their usual amount
Time frame: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in rating 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, 5, 6
Change in rating 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, 5, 6
Change in rating 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, 5, 6
Change in rating 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, 5, 6
Change in estimation of proportion of meal eaten
Time frame: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Change in estimation of calories consumed at the meal
Time frame: At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low variety, High Variety and Small Portion Size in people with Eating Behavior, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intake by weight (time frame: Weeks 1, 2, 3, 4, 5, 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.