Appetite Self-regulationNCT05258097
Food Form & Energy Intake
An observational study of Appetite Self-regulation and Pediatric Obesity, run by Penn State University at 2 sites in United States.
Trial summary
This study primarily aims to examine how food presented in various forms (i.e., solid, semi-solid, and liquid) affects children's ability to self-regulate energy intake at a subsequent meal. Read more about this study
- Who is it for?
- Ages 54 to 83 monthsHealthy volunteers can take part
- Conditions the study is for
- Appetite Self-regulation, Pediatric Obesity
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2021to 2 Nov 2024
- Phase
- Observational
- 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 54 to 83 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children ages 4.5-6 years and their parents from Centre County, Pennsylvania and surrounding areas
Who may be able to join
- Children between the ages of 4.5-6 years-old
- Physically healthy (no major disabilities or disease states)
- Free of any known food allergies
- Free of any medical conditions that affect appetite or ability to follow study protocol
- Not taking medications that affect appetite or ability to follow study protocol
- Like and willing to consume apple slices, apple sauce, and apple juice as well as at least 4 of the 5 ad libitum meal test foods according to parental report on a screening questionnaire
- Parent or legal guardian primarily in charge of feeding child able to attend all 5 visits
Who cannot join
- Children with medical condition affecting appetite or ability to follow study protocol, including but not limited to autism, ADHD, or developmental delays
- Children taking medications (prescription or over-the-counter) that may affect appetite or ability to follow study protocols
- Children younger than 4.5 years or older than 6 years
- Children with major disability or disease state
- Children with food allergies of any kind or severity
- Children who do not like/are not willing to consume all three of the following: apple slices, apple sauce, and apple juice
- Children who do not like/are not willing to consume at least four of the five test meal foods
- Parent or legal guardian primarily in charge of feeding the child not able to attend all 5 study visits
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Metabolic Kitchen and Children's Eating Behavior Lab
University Park, Pennsylvania, 16802
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Examining the Effects of Food Form and Individual Differences on Children's Self-regulation of Energy Intake
This study primarily aims to examine how food presented in various forms (i.e., solid, semi-solid, and liquid) affects children's ability to self-regulate energy intake at a subsequent meal. Additionally, this study aims to examine how several child-level individual differences are associated with differences in various aspects of children's appetite self-regulation. The investigators will recruit 78 children between the ages of 4.5-6 years in order to test the primary hypothesis that energy presented in a liquid form will elicit poorer self-regulation than solid and semi-solid food forms.
Read the detailed description
A detailed registered report of the following methods can be found at: http://journal.frontiersin.org/article/10.3389/fnut.2022.791718/full?\&utm_source=Email_to_authors_\&utm_medium=Email\&utm_content=T1_11.5e1_author\&utm_campaign=Email_publication\&field=\&journalName=Frontiers_in_Nutrition\&id=791718
Overview This study aims to examine how various factors, including food form and child-level individual differences, affect appetite self-regulation. The primary aim of this study is to examine how apples presented in solid, semi-solid, and liquid forms (apple slices, apple sauce, apple juice, respectively) differentially affect children's ability to compensate for this energy at a subsequent ad libitum test meal.
In order to test this hypothesis, a within-subjects, crossover design with repeated measures will be used to test 78, 4.5-6.0 year-old children' energy compensation using a standard preloading paradigm (Johnson \& Birch 1994; Birch \& Deysher 1986). Children and their parents will visit the Metabolic Kitchen and Children's Eating Behavior Lab at Penn State once a week over an approximate 5-week period, for a total of five, one and a half hour sessions. On each test session, children will be served one of five preload conditions: apple slices, apple sauce, regular apple juice, apple juice sweetened with non-nutritive sweetener (NNS), or no preload. The same standardized test meal of foods commonly accepted in this age group (described below) will then be served ∼20 min after the start of preload consumption. Families will attend either lunch or dinner meals based on availability, but meal times will be kept consistent within families. Children will be fasted for 3 h upon arrival to each visit.
Energy compensation Energy compensation will be examined by comparing meal intake following each preload condition. Apple slices, apple sauce, and regular apple juice will be matched for energy content, weight, and energy density. The NNS preload will be matched for weight with the other preloads. Apple slices (133 g) will be served to children without the skin. Apple sauce will be prepared using 133 g peeled, sliced apples heated for 20 min at 350 degrees Fahrenheit. Once cooked, the apples will be puréed and any water lost during heating will be added back to ensure consistent weight between preload conditions. Apple juice (133 g) will be 120.4 g of Mott's 100% Apple Juice (Mott's, Mott's Inc., Plano, TX) and 12.6 g water to match the weight and energy density of the apple slices and apple sauce. Lastly, NNS apple juice (133 g) will be prepared with 66.5 g Mott's Light Apple Juice (Mott's, Mott's Inc., Plano, TX) and 66.5 g Old Orchard Healthy Balance Diet Apple Juice Cocktail (Old Orchard Brands LLC, Lassonde Industries Inc., Sparta, MI).
Preload ingestion time will be controlled and preload volume will be masked in each of the conditions. Preloads will be disguised under an apple-themed box to reduce perceptions of volume. Audio recordings of a story were developed to control ingestion rate. These stories will be played for the children during preload consumption and mention a key word ("apple") 16 times, once every 45 seconds. When the key word is mentioned, children are to reach into the box and pull out a soufflé cup containing one pre-portioned amount of the preload.
Approximately 20 minutes after the start of the preload, children will be served an ad libitum test meal of : macaroni and cheese (Kraft, Kraft Heinz Co., Chicago, IL), frozen broccoli florets (Birds Eye, Conagra Brands, Chicago, IL), red grapes (Wegmans, Wegmans Food Markets, Rochester, NY), baby carrots (Wegmans, Wegmans Food Markets, Rochester, NY), graham crackers (Nabisco Original, Nabisco, East Hanover, NJ), and water.
Aims and Hypotheses:
Aim 1 of this study is to examine the effect of food form on children's subsequent energy intake. The investigators hypothesize that energy intake at the ad libitum test meal will be greatest following the liquid (apple juice) preload, indicating the lowest satiety and poorest appetite self-regulation during this preload condition compared to apple sauce and apple slices matched for energy content. Conversely, we expect meal energy intake to be lowest following the solid (apple slice) preload, indicating greatest satiety and appetite self-regulation on this condition compared to apple juice and apple sauce conditions. We hypothesize that meal intake following apple sauce will be greater than that following the apple slices but lower than that following apple juice, based on previous findings in adults (Flood-Obbagy \& Rolls 2009).
Aim 2 of this study is to examine energy compensation by comparing meal intakes following the apple juice preload and the NNS apple juice preload. Energy compensation will be quantified by calculating COMPx (Johnson \& Birch 1994). We hypothesize that children, on average, will demonstrate good COMPx but that there will be wide variability in this measure.
Aim 3 of this study is to examine sex differences in children's COMPx. We hypothesize that boys will demonstrate better COMPx than girls.
Secondary aims of this study are to examine other measures of appetite self-regulation (eating in the absence of hunger and food-specific delay of gratification) and how they may be associated with energy compensation for food form and COMPx. Additionally, exploratory analyses will examine how these measures of appetite self-regulation relate to child-level individual differences of sex, body composition assessed via dual X-ray absorptiometry, anthropometrics, previous exposure to NNS, respiratory sinus arrhythmia, social desirability, and portion size discrimination.
- Conditions
- Appetite Self-regulation, Pediatric Obesity
- Keywords
- appetite self-regulation, pediatric obesity, COMPx, energy compensation, preload, food form, eating in the absence of hunger, eating behavior
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Boys | Child sex based on parent report on a screening questionnaire | |
| Girls | Child sex based on parent report on a screening questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy compensation by food form
Meal intake in kilocalories following each of the three caloric preloads (apple slices, apple sauce, apple juice)
Measured: Baseline
Energy compensation (COMPx) for two juice preloads
COMPx for the two juice preloads using the following equation: ((Meal kcal following NNS juice - Meal kcal following regular juice) / (Regular juice kcal - NNS juice kcal)) x100
Measured: Baseline
Sex differences
Differences in COMPx by child sex
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start2 Nov 2021
- Primary completion2 Nov 2024 (estimated)
- Study completion2 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Appetite Self-regulationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Social Sciences Research Institute at Penn State University, Clinical and Translational Sciences Institute at Penn State University, Clinical Research Center at Penn State University
- Responsible party
- Principal investigator, Kathleen Loralee Keller, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258097
- Sponsor's protocol ID
- Apple Study
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available by request upon study completion
Publications
Johnson SL, Birch LL. Parents' and children's adiposity and eating style. Pediatrics. 1994 Nov;94(5):653-61.
PubMed 7936891Birch LL, Deysher M. Caloric compensation and sensory specific satiety: evidence for self regulation of food intake by young children. Appetite. 1986 Dec;7(4):323-31. doi: 10.1016/s0195-6663(86)80001-0.
PubMed 3789709Flood-Obbagy JE, Rolls BJ. The effect of fruit in different forms on energy intake and satiety at a meal. Appetite. 2009 Apr;52(2):416-22. doi: 10.1016/j.appet.2008.12.001. Epub 2008 Dec 6.
PubMed 19110020
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Food Form and Individual Differences on Children's Self-regulation of Energy Intake
- ClinicalTrials.gov ID
- NCT05258097
- Acronym / sponsor ID
- Apple Study
- Conditions
- Appetite Self-regulation, Pediatric Obesity
- Keywords
- appetite self-regulation, pediatric obesity, COMPx, energy compensation, preload, food form, eating in the absence of hunger, eating behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Social Sciences Research Institute at Penn State University, Clinical and Translational Sciences Institute at Penn State University, Clinical Research Center at Penn State University
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 2 Nov 2024 (estimated)
- Study completion
- 2 Nov 2024 (estimated)
- First posted
- 28 Feb 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.
This study primarily aims to examine how food presented in various forms (i.e., solid, semi-solid, and liquid) affects children's ability to self-regulate energy intake at a subsequent meal. Additionally, this study aims to examine how several child-level individual differences are associated with differences in various aspects of children's appetite self-regulation. The investigators will recruit 78 children between the ages of 4.5-6 years in order to test the primary hypothesis that energy presented in a liquid form will elicit poorer self-regulation than solid and semi-solid food forms.
Detailed description
A detailed registered report of the following methods can be found at: http://journal.frontiersin.org/article/10.3389/fnut.2022.791718/full?\&utm_source=Email_to_authors_\&utm_medium=Email\&utm_content=T1_11.5e1_author\&utm_campaign=Email_publication\&field=\&journalName=Frontiers_in_Nutrition\&id=791718
Overview This study aims to examine how various factors, including food form and child-level individual differences, affect appetite self-regulation. The primary aim of this study is to examine how apples presented in solid, semi-solid, and liquid forms (apple slices, apple sauce, apple juice, respectively) differentially affect children's ability to compensate for this energy at a subsequent ad libitum test meal.
In order to test this hypothesis, a within-subjects, crossover design with repeated measures will be used to test 78, 4.5-6.0 year-old children' energy compensation using a standard preloading paradigm (Johnson \& Birch 1994; Birch \& Deysher 1986). Children and their parents will visit the Metabolic Kitchen and Children's Eating Behavior Lab at Penn State once a week over an approximate 5-week period, for a total of five, one and a half hour sessions. On each test session, children will be served one of five preload conditions: apple slices, apple sauce, regular apple juice, apple juice sweetened with non-nutritive sweetener (NNS), or no preload. The same standardized test meal of foods commonly accepted in this age group (described below) will then be served ∼20 min after the start of preload consumption. Families will attend either lunch or dinner meals based on availability, but meal times will be kept consistent within families. Children will be fasted for 3 h upon arrival to each visit.
Energy compensation Energy compensation will be examined by comparing meal intake following each preload condition. Apple slices, apple sauce, and regular apple juice will be matched for energy content, weight, and energy density. The NNS preload will be matched for weight with the other preloads. Apple slices (133 g) will be served to children without the skin. Apple sauce will be prepared using 133 g peeled, sliced apples heated for 20 min at 350 degrees Fahrenheit. Once cooked, the apples will be puréed and any water lost during heating will be added back to ensure consistent weight between preload conditions. Apple juice (133 g) will be 120.4 g of Mott's 100% Apple Juice (Mott's, Mott's Inc., Plano, TX) and 12.6 g water to match the weight and energy density of the apple slices and apple sauce. Lastly, NNS apple juice (133 g) will be prepared with 66.5 g Mott's Light Apple Juice (Mott's, Mott's Inc., Plano, TX) and 66.5 g Old Orchard Healthy Balance Diet Apple Juice Cocktail (Old Orchard Brands LLC, Lassonde Industries Inc., Sparta, MI).
Preload ingestion time will be controlled and preload volume will be masked in each of the conditions. Preloads will be disguised under an apple-themed box to reduce perceptions of volume. Audio recordings of a story were developed to control ingestion rate. These stories will be played for the children during preload consumption and mention a key word ("apple") 16 times, once every 45 seconds. When the key word is mentioned, children are to reach into the box and pull out a soufflé cup containing one pre-portioned amount of the preload.
Approximately 20 minutes after the start of the preload, children will be served an ad libitum test meal of : macaroni and cheese (Kraft, Kraft Heinz Co., Chicago, IL), frozen broccoli florets (Birds Eye, Conagra Brands, Chicago, IL), red grapes (Wegmans, Wegmans Food Markets, Rochester, NY), baby carrots (Wegmans, Wegmans Food Markets, Rochester, NY), graham crackers (Nabisco Original, Nabisco, East Hanover, NJ), and water.
Aims and Hypotheses:
Aim 1 of this study is to examine the effect of food form on children's subsequent energy intake. The investigators hypothesize that energy intake at the ad libitum test meal will be greatest following the liquid (apple juice) preload, indicating the lowest satiety and poorest appetite self-regulation during this preload condition compared to apple sauce and apple slices matched for energy content. Conversely, we expect meal energy intake to be lowest following the solid (apple slice) preload, indicating greatest satiety and appetite self-regulation on this condition compared to apple juice and apple sauce conditions. We hypothesize that meal intake following apple sauce will be greater than that following the apple slices but lower than that following apple juice, based on previous findings in adults (Flood-Obbagy \& Rolls 2009).
Aim 2 of this study is to examine energy compensation by comparing meal intakes following the apple juice preload and the NNS apple juice preload. Energy compensation will be quantified by calculating COMPx (Johnson \& Birch 1994). We hypothesize that children, on average, will demonstrate good COMPx but that there will be wide variability in this measure.
Aim 3 of this study is to examine sex differences in children's COMPx. We hypothesize that boys will demonstrate better COMPx than girls.
Secondary aims of this study are to examine other measures of appetite self-regulation (eating in the absence of hunger and food-specific delay of gratification) and how they may be associated with energy compensation for food form and COMPx. Additionally, exploratory analyses will examine how these measures of appetite self-regulation relate to child-level individual differences of sex, body composition assessed via dual X-ray absorptiometry, anthropometrics, previous exposure to NNS, respiratory sinus arrhythmia, social desirability, and portion size discrimination.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boys | – | –Child sex based on parent report on a screening questionnaire |
| Girls | – | –Child sex based on parent report on a screening questionnaire |
Who may qualify
- Ages
- 54 to 83 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children ages 4.5-6 years and their parents from Centre County, Pennsylvania and surrounding areas
Key inclusion criteria (7 listed)
- Children between the ages of 4.5-6 years-old
- Physically healthy (no major disabilities or disease states)
- Free of any known food allergies
- Free of any medical conditions that affect appetite or ability to follow study protocol
- Not taking medications that affect appetite or ability to follow study protocol
Key exclusion criteria (8 listed)
- Children with medical condition affecting appetite or ability to follow study protocol, including but not limited to autism, ADHD, or developmental delays
- Children taking medications (prescription or over-the-counter) that may affect appetite or ability to follow study protocols
- Children younger than 4.5 years or older than 6 years
- Children with major disability or disease state
- Children with food allergies of any kind or severity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Energy compensation by food form
Time frame: Baseline
Meal intake in kilocalories following each of the three caloric preloads (apple slices, apple sauce, apple juice)
Energy compensation (COMPx) for two juice preloads
Time frame: Baseline
COMPx for the two juice preloads using the following equation: ((Meal kcal following NNS juice - Meal kcal following regular juice) / (Regular juice kcal - NNS juice kcal)) x100
Sex differences
Time frame: Baseline
Differences in COMPx by child sex
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 7936891Johnson SL, Birch LL. Parents' and children's adiposity and eating style. Pediatrics. 1994 Nov;94(5):653-61.
- Background: PubMed 3789709Birch LL, Deysher M. Caloric compensation and sensory specific satiety: evidence for self regulation of food intake by young children. Appetite. 1986 Dec;7(4):323-31. doi: 10.1016/s0195-6663(86)80001-0.
- Background: PubMed 19110020Flood-Obbagy JE, Rolls BJ. The effect of fruit in different forms on energy intake and satiety at a meal. Appetite. 2009 Apr;52(2):416-22. doi: 10.1016/j.appet.2008.12.001. Epub 2008 Dec 6.
- Registered Report that details the methods of this studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be available by request upon study completion
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appetite Self-regulation and Pediatric Obesity, run by Penn State University at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Energy compensation by food form (time frame: Baseline). 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 NCT05258097, which also lists 3 linked publications.
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 31 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.