Food Form & Energy Intake

NCT05258097 | Unknown

• 1 other identifier: Apple Study
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 2

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (3)

• Energy compensation by food form

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

  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

  Baseline

• Sex differences

  Differences in COMPx by child sex

  Baseline

Study Arms (2)

Boys

Child sex based on parent report on a screening questionnaire

Girls

Child sex based on parent report on a screening questionnaire

Eligibility Criteria

• Age: 54 Months - 83 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children ages 4.5-6 years and their parents from Centre County, Pennsylvania and surrounding areas

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• Social Sciences Research Institute at Penn State University: collaborator
• Clinical and Translational Sciences Institute at Penn State University: collaborator
• Clinical Research Center at Penn State University: collaborator

Study Sites (2)

Metabolic Kitchen and Children's Eating Behavior Lab

University Park, Pennsylvania, 16802, United States

Location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

• Johnson SL, Birch LL. Parents' and children's adiposity and eating style. Pediatrics. 1994 Nov;94(5):653-61.

  PMID: 7936891 BACKGROUND

• 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.

  PMID: 3789709 BACKGROUND

• 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.

  PMID: 19110020 BACKGROUND

Related Links

• Registered Report that details the methods of this study

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: November 2, 2021
• Primary Completion: November 2, 2024
• Study Completion: November 2, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (2)