Feeding BehaviorNCT03409601
The Role of Satiety in the Effect of Portion Size on Intake
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 study uses a crossover design in which the portion size of food is varied at each meal. Across four test meals, subjects will be served four different portions of food, and intake will be determined from pre- and post-meal food weights. Read more about this study
- Who is it for?
- Ages 20 to 65 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
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 14 Dec 2018
- 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
- 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 - 60 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-squared
- Be willing to refrain from eating after 10 pm the evening before test sessions
Who cannot join
- A smoker
- An athlete in training
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
The study uses a crossover design in which the portion size of food is varied at each meal. Across four test meals, subjects will be served four different portions of food, and intake will be determined from pre- and post-meal food weights. The first visit will be a screening visit, at which subjects will complete the consent form, have their height and weight measured, and rate the taste of the study food. Test meals will be scheduled once a week for four weeks. At visits 2-5, subjects will eat lunch and rate characteristics of the meal. At visit 6, subjects will complete various questionnaires. The objective of this study is to determine whether any individual characteristics related to satiety influence the effect of portion size on intake.
- Conditions
- Feeding Behavior
- Being tested
- 100% Portion Size, 125% Portion Size, 150% Portion Size, 175% Portion Size
- Keywords
- Obesity, eating behavior, food, nutrition
- Medical subject headings
- Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% Portion SizeOther
Meal portion size at baseline
125% Portion SizeOther
Meal portion size 125% of baseline
150% Portion SizeOther
Meal portion size 150% of baseline
175% Portion SizeOther
Meal portion size 175% of baseline
| Study group | Role | What they receive |
|---|---|---|
| 100% Portion Size | Experimental | Test meal consists of baseline (100%) portion size of meal. Receives: Other: 100% Portion Size |
| 125% Portion Size | Experimental | Test meal consists of food portion size that is 125% the size of baseline portion. Receives: Other: 125% Portion Size |
| 150% Portion Size | Experimental | Test meal consists of food portion size that is 150% the size of baseline portion. Receives: Other: 150% Portion Size |
| 175% Portion Size | Experimental | Test meal consists of food portion size that is 175% the size of baseline portion. Receives: Other: 175% Portion Size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in energy intake
Calculated energy intake (kcal) based on weight and energy density of food consumed
Measured: Weeks 1, 2, 3, and 4
Differences in intake by weight
Weights (grams) of all foods consumed
Measured: Weeks 1, 2, 3, and 4
Secondary outcomes (5)
Sensory-specific satiety
Change in taste pleasantness of eaten foods compared to uneaten foods
Measured: Weeks 1, 2, 3, and 4
Eating rate
Assessed from meal duration and number of bites taken
Measured: Weeks 1, 2, 3, and 4
Ratings of hunger and satiety
100-point visual analog scales
Measured: Weeks 1, 2, 3, and 4
Ratings of sensory characteristics of the food
100-point visual analog scales
Measured: Weeks 1, 2, 3, and 4
Ratings of meal characteristics
100-point visual analog scales
Measured: Weeks 1, 2, 3, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start2 Apr 2018
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Why it stopped: Additional outcome measures have been developed and added to the protocol.
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara J. Rolls, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409601
- Sponsor's protocol ID
- PortionSize104
- Status last verified
- Mar 2019
- First submitted
- 18 Jan 2018
- Last updated
- 18 Mar 2019
- 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 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Satiety in the Effect of Portion Size on Intake
- ClinicalTrials.gov ID
- NCT03409601
- Acronym / sponsor ID
- PortionSize104
- Conditions
- Feeding Behavior
- Keywords
- Obesity, eating behavior, food, nutrition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Additional outcome measures have been developed and added to the protocol.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 24 Jan 2018 (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 study uses a crossover design in which the portion size of food is varied at each meal. Across four test meals, subjects will be served four different portions of food, and intake will be determined from pre- and post-meal food weights. The first visit will be a screening visit, at which subjects will complete the consent form, have their height and weight measured, and rate the taste of the study food. Test meals will be scheduled once a week for four weeks. At visits 2-5, subjects will eat lunch and rate characteristics of the meal. At visit 6, subjects will complete various questionnaires. The objective of this study is to determine whether any individual characteristics related to satiety influence the effect of portion size on intake.
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 consists of baseline (100%) portion size of meal. |
| 125% Portion Size | Experimental | Other: 125% Portion SizeTest meal consists of food portion size that is 125% the size of baseline portion. |
| 150% Portion Size | Experimental | Other: 150% Portion SizeTest meal consists of food portion size that is 150% the size of baseline portion. |
| 175% Portion Size | Experimental | Other: 175% Portion SizeTest meal consists of food portion size that is 175% the size of baseline portion. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be willing and able to travel to Penn State University Park campus weekly for meals
- Be a man or woman 18 - 60 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-squared
Key exclusion criteria (8 listed)
- A smoker
- An athlete in training
- 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 SizeMeal portion size at baseline | Other | 100% Portion Size |
| 125% Portion SizeMeal portion size 125% of baseline | Other | 125% Portion Size |
| 150% Portion SizeMeal portion size 150% of baseline | Other | 150% Portion Size |
| 175% Portion SizeMeal portion size 175% of baseline | Other | 175% Portion Size |
Primary outcome
Differences in energy intake
Time frame: Weeks 1, 2, 3, and 4
Calculated energy intake (kcal) based on weight and energy density of food consumed
Differences in intake by weight
Time frame: Weeks 1, 2, 3, and 4
Weights (grams) of all foods consumed
5 secondary outcomes
Sensory-specific satiety
Time frame: Weeks 1, 2, 3, and 4
Eating rate
Time frame: Weeks 1, 2, 3, and 4
Ratings of hunger and satiety
Time frame: Weeks 1, 2, 3, and 4
Ratings of sensory characteristics of the food
Time frame: Weeks 1, 2, 3, and 4
Ratings of meal characteristics
Time frame: Weeks 1, 2, 3, and 4
Results and safety
The study was stopped early (reason given: Additional outcome measures have been developed and added to the protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Mar 2019. 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 stopped early (reason given: Additional outcome measures have been developed and added to the protocol.). Results are not available in the source record.
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?
Differences in energy intake (time frame: Weeks 1, 2, 3, and 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 18 Mar 2019.