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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in United States

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.

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 groups in NCT05258097
Study groupRoleWhat they receive
BoysChild sex based on parent report on a screening questionnaire
GirlsChild 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.

  1. Energy compensation by food form

    Meal intake in kilocalories following each of the three caloric preloads (apple slices, apple sauce, apple juice)

    Measured: Baseline

  2. 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

  3. 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.

  1. First posted28 Feb 2022
  2. Study start2 Nov 2021
  3. Primary completion2 Nov 2024 (estimated)
  4. Study completion2 Nov 2024 (estimated)

Resources

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)
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 7936891
  • Birch 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 3789709
  • Flood-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

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.

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