Feeding BehaviorsNCT02369588
Effects of Portion Size of Multiple Items at a Meal on Food Intake of Adults
A study testing Food portion size in people with Feeding Behaviors, run by Penn State University at 1 site in United States.
Trial summary
This study tests the effect of serving larger portions of all foods in a meal on the outcome of food and energy intake. Using a crossover design, participants are served the meal once a week for four weeks and the portion sizes are varied at each meal. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Feeding Behaviors
- What is being tested?
- Food portion size
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2013
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index of 18 to 40 kg/square meter
- Regularly eat three meals per day
- Willing to eat foods served at test meals
Who cannot join
- Food allergies or restrictions
- Dieting to gain or lose weight
- Taking medications known to affect appetite
- Smoker
- Athlete in training
- Currently pregnant or breast-feeding
- Questionnaire score indicative of depression
- Questionnaire score indicative of disordered eating attitudes
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16802
About this study
This study tests the effect of serving larger portions of all foods in a meal on the outcome of food and energy intake. Using a crossover design, participants are served the meal once a week for four weeks and the portion sizes are varied at each meal. Some of the foods served at the meal are low in calorie density (calories per gram) and some are higher in calorie density. The aim is to determine whether intake in response to larger portions differs depending on characteristics of the subjects or of the foods.
- Conditions
- Feeding Behaviors
- Being tested
- Food 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.
Food portion sizeOther
| Study group | Role | What they receive |
|---|---|---|
| 100% Portion Sizes | Experimental | Food portion size Test meal consists of baseline (100%) portion size of all foods Receives: Other: Food portion size |
| 133% Portion Sizes | Experimental | Food portion size Test meal consists of portion sizes of all foods that are 133% the size of baseline portions Receives: Other: Food portion size |
| 167% Portion Sizes | Experimental | Food portion size Test meal consists of portion sizes of all foods that are 167% the size of baseline portions Receives: Other: Food portion size |
| 200% Portion Sizes | Experimental | Food portion size Test meal consists of portion sizes of all foods that are 200% the size of baseline portions Receives: Other: Food portion size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in meal food intake
Differences in weight of food consumed (grams) at the meals
Measured: Weeks 1, 2, 3, and 4
Differences in meal energy intake
Differences in energy of food consumed (kilocalories) at the meals
Measured: Weeks 1, 2, 3, and 4
Differences in meal energy density
Differences in energy density of food consumed (kilocalories per gram) at the meal
Measured: Weeks 1, 2, 3, and 4
Secondary outcomes (2)
Differences in hunger and satiety
Differences in ratings of hunger and satiety either before or after the meal, as assessed by 100-mm visual analog scales (mm)
Measured: Weeks 1, 2, 3, and 4
Differences in ratings of food properties
Differences in ratings of food properties (such as taste or healthfulness) as assessed either by 100-mm visual analog scales (mm) or ranking (rank order)
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 Feb 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorsStudies 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
- None (open label)
- Enrolment
- 51 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
- Investigators
- Barbara J. Rolls, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369588
- Sponsor's protocol ID
- PortionSize102
- Other IDs
- R01DK059853
- Status last verified
- Feb 2015
- First submitted
- 17 Feb 2015
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Roe LS, Kling SMR, Rolls BJ. What is eaten when all of the foods at a meal are served in large portions? Appetite. 2016 Apr 1;99:1-9. doi: 10.1016/j.appet.2016.01.001. Epub 2016 Jan 5.
PubMed 26767612
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Portion Size of Multiple Items at a Meal on Food Intake of Adults
- ClinicalTrials.gov ID
- NCT02369588
- Acronym / sponsor ID
- PortionSize102
- Conditions
- Feeding Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Feb 2015 (estimated)
- 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.
This study tests the effect of serving larger portions of all foods in a meal on the outcome of food and energy intake. Using a crossover design, participants are served the meal once a week for four weeks and the portion sizes are varied at each meal. Some of the foods served at the meal are low in calorie density (calories per gram) and some are higher in calorie density. The aim is to determine whether intake in response to larger portions differs depending on characteristics of the subjects or of the foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100% Portion Sizes | Experimental | Other: Food portion sizeFood portion size Test meal consists of baseline (100%) portion size of all foods |
| 133% Portion Sizes | Experimental | Other: Food portion sizeFood portion size Test meal consists of portion sizes of all foods that are 133% the size of baseline portions |
| 167% Portion Sizes | Experimental | Other: Food portion sizeFood portion size Test meal consists of portion sizes of all foods that are 167% the size of baseline portions |
| 200% Portion Sizes | Experimental | Other: Food portion sizeFood portion size Test meal consists of portion sizes of all foods that are 200% the size of baseline portions |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index of 18 to 40 kg/square meter
- Regularly eat three meals per day
- Willing to eat foods served at test meals
Key exclusion criteria (8 listed)
- Food allergies or restrictions
- Dieting to gain or lose weight
- Taking medications known to affect appetite
- Smoker
- Athlete in training
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 |
|---|---|---|
| Food portion size | Other | 100% Portion Sizes, 133% Portion Sizes, 167% Portion Sizes, 200% Portion Sizes |
Primary outcome
Differences in meal food intake
Time frame: Weeks 1, 2, 3, and 4
Differences in weight of food consumed (grams) at the meals
Differences in meal energy intake
Time frame: Weeks 1, 2, 3, and 4
Differences in energy of food consumed (kilocalories) at the meals
Differences in meal energy density
Time frame: Weeks 1, 2, 3, and 4
Differences in energy density of food consumed (kilocalories per gram) at the meal
2 secondary outcomes
Differences in hunger and satiety
Time frame: Weeks 1, 2, 3, and 4
Differences in ratings of food properties
Time frame: Weeks 1, 2, 3, and 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 24 Feb 2015.
- Derived from this study: PubMed 26767612Roe LS, Kling SMR, Rolls BJ. What is eaten when all of the foods at a meal are served in large portions? Appetite. 2016 Apr 1;99:1-9. doi: 10.1016/j.appet.2016.01.001. Epub 2016 Jan 5.
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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.
Barbara J. Rolls principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food portion size in people with Feeding Behaviors, 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 3 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: finished, as of the sponsor's last update on 24 Feb 2015. 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?
Differences in meal food intake (time frame: Weeks 1, 2, 3, and 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369588, which also lists 1 linked publication.
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 24 Feb 2015.