Eating BehaviorNCT05485168
Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women
A study testing Sequential Variety, Single-Food and Small Portion 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 investigate the combined effects of sequential 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. 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?
- Sequential Variety, Single-Food and Small Portion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 7 Apr 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 have a high variability in liking of the test foods
Show all 10Show fewer
- 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
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 investigate the combined effects of sequential 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.
- Conditions
- Eating Behavior
- Being tested
- Sequential Variety, Single-Food, Small Portion, Large Portion
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential VarietyOther
3 different foods served in 3 successive courses
Single-FoodOther
1 food served in 3 successive courses
Small PortionOther
Small meal portion size
Large PortionOther
Large meal portion size
| Study group | Role | What they receive |
|---|---|---|
| Sequential Variety, Small Portion | Experimental | 3 different foods served in a small portion in 3 successive courses Receives: Other: Sequential Variety; Other: Small Portion |
| Sequential Variety, Large Portion | Experimental | 3 different foods served in a large portion in 3 successive courses Receives: Other: Sequential Variety; Other: Large Portion |
| Single-Food, Small Portion | Experimental | 1 food served in a small portion in 3 successive courses Receives: Other: Single-Food; Other: Small Portion |
| Single-Food, Large Portion | Experimental | 1 food served in a large portion in 3 successive courses Receives: Other: Single-Food; Other: Large Portion |
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
Change in energy intake
Energy intake (kilocalories) of all meal components consumed, calculated from weight and energy density
Measured: Weeks 1, 2, 3, 4
Secondary outcomes (15)
Change in bite count
The number of bites of food during the meal
Measured: Weeks 1, 2, 3, 4
Change in active eating time
Duration of the time spent eating in minutes
Measured: Weeks 1, 2, 3, 4
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
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
Change in sip count
The number of sips of water during the meal
Measured: Weeks 1, 2, 3, 4
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
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
Change in switching between bites and sips
The number of switches between bites and sips during the meal
Measured: Weeks 1, 2, 3, 4
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: Weeks 1, 2, 3, 4
Change in rating of desire to eat food samples
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.
Measured: Weeks 1, 2, 3, 4
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: Weeks 1, 2, 3, 4
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: Weeks 1, 2, 3, 4
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: Weeks 1, 2, 3, 4
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: Weeks 1, 2, 3, 4
Change in rating of prospective consumption
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?".
Measured: Weeks 1, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start6 Sep 2022
- Primary completion3 Apr 2023
- Study completion7 Apr 2023
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
- 52 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
- NCT05485168
- Sponsor's protocol ID
- FoodVariety104
- Status last verified
- Sep 2023
- First submitted
- 28 Jul 2022
- Last updated
- 22 Sep 2023
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women
- ClinicalTrials.gov ID
- NCT05485168
- Acronym / sponsor ID
- FoodVariety104
- Conditions
- Eating Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Jenny Craig, Inc.
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 3 Aug 2022 (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 investigate the combined effects of sequential 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequential Variety, Small Portion | Experimental | Other: Sequential Variety, Other: Small Portion3 different foods served in a small portion in 3 successive courses |
| Sequential Variety, Large Portion | Experimental | Other: Sequential Variety, Other: Large Portion3 different foods served in a large portion in 3 successive courses |
| Single-Food, Small Portion | Experimental | Other: Single-Food, Other: Small Portion1 food served in a small portion in 3 successive courses |
| Single-Food, Large Portion | Experimental | Other: Single-Food, Other: Large Portion1 food served in a large portion in 3 successive courses |
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 (10 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 |
|---|---|---|
| Sequential Variety3 different foods served in 3 successive courses | Other | Sequential Variety, Large Portion, Sequential Variety, Small Portion |
| Single-Food1 food served in 3 successive courses | Other | Single-Food, Large Portion, Single-Food, Small Portion |
| Small PortionSmall meal portion size | Other | Sequential Variety, Small Portion, Single-Food, Small Portion |
| Large PortionLarge meal portion size | Other | Sequential Variety, Large Portion, Single-Food, Large Portion |
Primary outcome
Change in intake by weight
Time frame: Weeks 1, 2, 3, 4
Weight (grams) of all meal components consumed
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
15 secondary outcomes
Change in bite count
Time frame: Weeks 1, 2, 3, 4
Change in active eating time
Time frame: Weeks 1, 2, 3, 4
Change in mean eating rate
Time frame: Weeks 1, 2, 3, 4
Change in mean bite size
Time frame: Weeks 1, 2, 3, 4
Change in sip count
Time frame: Weeks 1, 2, 3, 4
Change in mean drinking rate
Time frame: Weeks 1, 2, 3, 4
Change in mean sip size
Time frame: Weeks 1, 2, 3, 4
Change in switching between bites and sips
Time frame: Weeks 1, 2, 3, 4
Change in rating of pleasantness of the taste of food samples
Time frame: Weeks 1, 2, 3, 4
Change in rating of desire to eat food samples
Time frame: Weeks 1, 2, 3, 4
Change in rating of hunger
Time frame: Weeks 1, 2, 3, 4
Change in rating of thirst
Time frame: Weeks 1, 2, 3, 4
Change in rating of nausea
Time frame: Weeks 1, 2, 3, 4
Change in rating of fullness
Time frame: Weeks 1, 2, 3, 4
Change in rating of prospective consumption
Time frame: Weeks 1, 2, 3, 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- 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 Sequential Variety, Single-Food and Small Portion 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 10 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: finished, as of the sponsor's last update on 22 Sep 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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). 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 22 Sep 2023.