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临床试验/NCT05258097
NCT05258097Enrolling By Invitation不适用

Examining the Effects of Food Form and Individual Differences on Children's Self-regulation of Energy Intake

Penn State University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
78
试验地点
2
主要终点
Energy compensation by food form

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
54 Months 至 83 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Energy compensation by food form

时间窗: Baseline

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

Sex differences

时间窗: Baseline

Differences in COMPx by child sex

Energy compensation (COMPx) for two juice preloads

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Loralee Keller

Associate Professor

Penn State University

研究点 (2)

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