Feeding BehaviorNCT03886428
The Influence of Satiation Measures on the Portion Size Effect
A study testing 100% portion size, 125% portion size and 150% portion size in people with Feeding Behavior, run by Penn State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Feeding Behavior
- What is being tested?
- 100% portion size, 125% portion size and 150% portion size
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2019to 13 Dec 2019
- 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 18 to 70 years
- All sexes
- 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 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
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
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: 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.
- Conditions
- Feeding Behavior
- Being tested
- 100% portion size, 125% portion size, 150% portion size, 175% portion size
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% portion sizeOther
Entree portion size 100% of baseline
125% portion sizeOther
Entree portion size 125% of baseline
150% portion sizeOther
Entree portion size 150% of baseline
175% portion sizeOther
Entree portion size 175% of baseline
| Study group | Role | What they receive |
|---|---|---|
| 100% Portion Size | Experimental | Test meal with portion size 100% of baseline Receives: Other: 100% portion size |
| 125% Portion Size | Experimental | Test meal with portion size 125% of baseline Receives: Other: 125% portion size |
| 150% Portion Size | Experimental | Test meal with portion size 150% of baseline Receives: Other: 150% portion size |
| 175% Portion Size | Experimental | Test meal with portion size 175% of baseline Receives: Other: 175% portion size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy intake
Calculated energy intake (kcal) based on weight and energy density of food consumed
Measured: Weeks 1, 2, 3, 4
Change in intake by weight
Weights (grams) of all foods consumed
Measured: Weeks 1, 2, 3, 4
Secondary outcomes (16)
Change in bite count
The number of bites of the entree during the meal
Measured: Weeks 1, 2, 3, 4
Change in meal duration
Duration of the meal in seconds
Measured: Weeks 1, 2, 3, 4
Change in mean bite rate
Assessed from meal duration (seconds) and number of bites taken
Measured: Weeks 1, 2, 3, 4
Change in mean bite size
Assessed from entree intake (grams) and number of bites
Measured: Weeks 1, 2, 3, 4
Change in mean eating rate
Assessed from entree intake (grams) and meal duration
Measured: Weeks 1, 2, 3, 4
Change in distribution of estimated bite size
Assessed as small or large bites from video observation
Measured: Weeks 1, 2, 3, 4
Change in sip count
The number of sips of the water during the meal
Measured: Weeks 1, 2, 3, 4
Change in rating of the pleasantness of the taste of the entree sample
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
Change in rating of the 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
Change in rating of prospective consumption of the entree sample
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
Measured: 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
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
Measured: From before the test meal to after the test meal in 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: From before the test meal to after the test meal in 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: From before the test meal to after the test meal in weeks 1, 2, 3, 4
Change in ratings 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 the question 'How much food could you eat right now?'.
Measured: From before the test meal to after the test meal in weeks 1, 2, 3, 4
Change in ratings 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start21 May 2019
- Primary completion11 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding 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
- 50 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
- NCT03886428
- Sponsor's protocol ID
- PortionSize106
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2019
- Last updated
- 13 Mar 2020
- 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 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lunch Feeding Study for Men and Women
- ClinicalTrials.gov ID
- NCT03886428
- Acronym / sponsor ID
- PortionSize106
- Conditions
- Feeding Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Jenny Craig, Inc.
- Study start
- 21 May 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 22 Mar 2019 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100% Portion Size | Experimental | Other: 100% portion sizeTest meal with portion size 100% of baseline |
| 125% Portion Size | Experimental | Other: 125% portion sizeTest meal with portion size 125% of baseline |
| 150% Portion Size | Experimental | Other: 150% portion sizeTest meal with portion size 150% of baseline |
| 175% Portion Size | Experimental | Other: 175% portion sizeTest meal with portion size 175% of baseline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
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
- 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)
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 |
|---|---|---|
| 100% portion sizeEntree portion size 100% of baseline | Other | 100% Portion Size |
| 125% portion sizeEntree portion size 125% of baseline | Other | 125% Portion Size |
| 150% portion sizeEntree portion size 150% of baseline | Other | 150% Portion Size |
| 175% portion sizeEntree portion size 175% of baseline | Other | 175% Portion Size |
Primary outcome
Change in energy intake
Time frame: Weeks 1, 2, 3, 4
Calculated energy intake (kcal) based on weight and energy density of food consumed
Change in intake by weight
Time frame: Weeks 1, 2, 3, 4
Weights (grams) of all foods consumed
16 secondary outcomes
Change in bite count
Time frame: Weeks 1, 2, 3, 4
Change in meal duration
Time frame: Weeks 1, 2, 3, 4
Change in mean bite rate
Time frame: Weeks 1, 2, 3, 4
Change in mean bite size
Time frame: Weeks 1, 2, 3, 4
Change in mean eating rate
Time frame: Weeks 1, 2, 3, 4
Change in distribution of estimated bite size
Time frame: Weeks 1, 2, 3, 4
Change in sip count
Time frame: Weeks 1, 2, 3, 4
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
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
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
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
Change in rating of hunger
Time frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
Change in rating of thirst
Time frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
Change in ratings of prospective consumption
Time frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
Change in ratings of nausea
Time frame: 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
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 13 Mar 2020.
- 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 100% portion size, 125% portion size and 150% portion size in people with Feeding 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 7 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: finished, as of the sponsor's last update on 13 Mar 2020. 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 energy intake (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 13 Mar 2020.