Feeding BehaviorNCT04404998
The Influence of Energy Density and Information on Meal Intake in Adults
A study testing Lower Energy Density, Higher Energy Density and Lower Satiation 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 how energy density and cognitive framing of satiation using food information can influence consumption at a meal. This study also aims to investigate the influence of energy density and food information on sensory specific satiety (the decline in the… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Feeding Behavior
- What is being tested?
- Lower Energy Density, Higher Energy Density and Lower Satiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2021to 8 Nov 2021
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to attend all test meals
- Be fully vaccinated against COVID-19
- Regularly eat 3 meals/day
- Being willing to avoid alcohol the day before and during test days
- Have a body mass index greater than 18.0 kg/meters squared
- Being willing to refrain from eating after 10 pm the evening before test sessions
Who cannot join
- Being a smoker
- Being an athlete in training
- Being 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 inability to eat the test foods
- 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
- Being 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
Official title: Lunch Meal Study for Men and Women
The purpose of this study is to gain a better understanding of how energy density and cognitive framing of satiation using food information can influence consumption at a meal. This study also aims to investigate the influence of energy density and food information on sensory specific satiety (the decline in the subjective pleasantness of a food as it is eaten).
- Conditions
- Feeding Behavior
- Being tested
- Lower Energy Density, Higher Energy Density, Lower Satiation, Higher Satiation
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Energy DensityOther
Test meal with lower energy density
Higher Energy DensityOther
Test meal with higher energy density
Lower SatiationOther
Information on lower satiation
Higher SatiationOther
Information on higher satiation
| Study group | Role | What they receive |
|---|---|---|
| Lower Energy Density & Lower Satiation | Experimental | Test meal with lower energy density and lower satiation information Receives: Other: Lower Energy Density; Other: Lower Satiation |
| Lower Energy Density & Higher Satiation | Experimental | Test meal with lower energy density and higher satiation information Receives: Other: Lower Energy Density; Other: Higher Satiation |
| Higher Energy Density & Lower Satiation | Experimental | Test meal with higher energy density and lower satiation information Receives: Other: Higher Energy Density; Other: Lower Satiation |
| Higher Energy Density & Higher Satiation | Experimental | Test meal with higher energy density and higher satiation information Receives: Other: Higher Energy Density; Other: Higher Satiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food intake by weight
Weight of food consumed measured in grams (g)
Measured: Weeks 1, 2, 3, 4
Change in energy intake
Energy content of food consumed measured in kilocalories (kcal)
Measured: Weeks 1, 2, 3, 4
Secondary outcomes (9)
Change in palatability rating of food samples
Difference between post-meal and pre-meal palatability of the food samples measured by Visual Analogue Scales (ranging from 0 mm to 100 mm) to assess Sensory-Specific Satiety
Measured: Weeks 1, 2, 3, 4
Change in prospective consumption rating of food samples
Difference between post-meal and pre-meal prospective consumption of food samples measured by Visual Analogue Scales (ranging from 0 mm to 100 mm) to assess Sensory-Specific Satiety
Measured: Weeks 1, 2, 3, 4
Change in hunger rating
Difference between post-meal and pre-meal hunger measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Measured: Weeks 1, 2, 3, 4
Change in fullness rating
Difference between post-meal and pre-meal fullness measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Measured: Weeks 1, 2, 3, 4
Change in test meal prospective consumption rating
Difference in prospective consumption measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Measured: Weeks 1, 2, 3, 4
Change in test meal fillingness rating
Difference in fillingness measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Measured: Weeks 1, 2, 3, 4
Change in test meal palatability rating
Difference in palatability of the test meal measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Measured: Weeks 1, 2, 3, 4
Change in estimation of proportion of test meal consumed
Difference in estimation of proportion of test meal consumed measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
Measured: Weeks 1, 2, 3, 4
Change in estimation of energy content of test meal consumed
Difference in estimation of energy content of test meal consumed measured by Visual Analogue Scales (ranging from 0 mm to 100 mm)
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 posted28 May 2020
- Study start3 Aug 2021
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Why it stopped: Issues with recruitment due to COVID 19
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
- 11 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
- NCT04404998
- Sponsor's protocol ID
- FoodED601
- Status last verified
- Dec 2021
- First submitted
- 11 Mar 2020
- Last updated
- 29 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 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lunch Meal Study for Men and Women
- ClinicalTrials.gov ID
- NCT04404998
- Acronym / sponsor ID
- FoodED601
- Conditions
- Feeding Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues with recruitment due to COVID 19
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 28 May 2020 (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 how energy density and cognitive framing of satiation using food information can influence consumption at a meal. This study also aims to investigate the influence of energy density and food information on sensory specific satiety (the decline in the subjective pleasantness of a food as it is eaten).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lower Energy Density & Lower Satiation | Experimental | Other: Lower Energy Density, Other: Lower SatiationTest meal with lower energy density and lower satiation information |
| Lower Energy Density & Higher Satiation | Experimental | Other: Lower Energy Density, Other: Higher SatiationTest meal with lower energy density and higher satiation information |
| Higher Energy Density & Lower Satiation | Experimental | Other: Higher Energy Density, Other: Lower SatiationTest meal with higher energy density and lower satiation information |
| Higher Energy Density & Higher Satiation | Experimental | Other: Higher Energy Density, Other: Higher SatiationTest meal with higher energy density and higher satiation information |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to attend all test meals
- Be fully vaccinated against COVID-19
- Regularly eat 3 meals/day
- Being willing to avoid alcohol the day before and during test days
- Have a body mass index greater than 18.0 kg/meters squared
Key exclusion criteria (9 listed)
- Being a smoker
- Being an athlete in training
- Being 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 inability to eat the test foods
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 |
|---|---|---|
| Lower Energy DensityTest meal with lower energy density | Other | Lower Energy Density & Higher Satiation, Lower Energy Density & Lower Satiation |
| Higher Energy DensityTest meal with higher energy density | Other | Higher Energy Density & Higher Satiation, Higher Energy Density & Lower Satiation |
| Lower SatiationInformation on lower satiation | Other | Higher Energy Density & Lower Satiation, Lower Energy Density & Lower Satiation |
| Higher SatiationInformation on higher satiation | Other | Higher Energy Density & Higher Satiation, Lower Energy Density & Higher Satiation |
Primary outcome
Change in food intake by weight
Time frame: Weeks 1, 2, 3, 4
Weight of food consumed measured in grams (g)
Change in energy intake
Time frame: Weeks 1, 2, 3, 4
Energy content of food consumed measured in kilocalories (kcal)
9 secondary outcomes
Change in palatability rating of food samples
Time frame: Weeks 1, 2, 3, 4
Change in prospective consumption rating of food samples
Time frame: Weeks 1, 2, 3, 4
Change in hunger rating
Time frame: Weeks 1, 2, 3, 4
Change in fullness rating
Time frame: Weeks 1, 2, 3, 4
Change in test meal prospective consumption rating
Time frame: Weeks 1, 2, 3, 4
Change in test meal fillingness rating
Time frame: Weeks 1, 2, 3, 4
Change in test meal palatability rating
Time frame: Weeks 1, 2, 3, 4
Change in estimation of proportion of test meal consumed
Time frame: Weeks 1, 2, 3, 4
Change in estimation of energy content of test meal consumed
Time frame: Weeks 1, 2, 3, 4
Results and safety
The study was stopped early (reason given: Issues with recruitment due to COVID 19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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 Lower Energy Density, Higher Energy Density and Lower Satiation 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 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: stopped early, as of the sponsor's last update on 29 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 stopped early (reason given: Issues with recruitment due to COVID 19). 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?
Change in food 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 29 Dec 2021.