Chewing, Eating Rate, and Weight Status in Children

NCT07808983 | Recruiting

• 1 other identifier: AU-HEA-VKS-20250811
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Childhood obesity is a multifactorial health condition associated with profound metabolic, psychosocial, and socioeconomic ramifications across the lifespan. Among eating behaviors associated with obesity, limited attention has been given to chewing and food texture as pathways that may influence energy intake and weight regulation. Existing pediatric research remains scarce, methodologically heterogeneous, and often inconclusive. Aims: This study aims to examine associations between oral processing behaviors during a standardized meal, including eating duration, eating rate, Ghrelin levels, and anthropometric measures in healthy children. Methods: Participants responding to public advertisements will be screened for eligibility, including age (6-11 years), health status, absence of food allergies or intolerances, dental or developmental problems, and measured weight and height to achieve a sample of 40 children with obesity and 40 with normal weight. In a randomized crossover design, participants will consume two isocaloric, non-processed test meals differing in food texture (soft vs. hard) during separate laboratory visits. Eating behavior will be objectively assessed using a Universal Eating Monitor with synchronized video analysis to quantify chewing time, number of chews, and eating rate. Salivary ghrelin, subjective satiety (measured using visual analog scales), and total daily energy intake (assessed via 24-hour dietary recall) will be evaluated, along with anthropometric, body composition, strength measures, and sociodemographic and behavioral data. To account for familial and shared environmental influences on eating behavior, at least one parent will undergo a parallel assessment, conducted separately from the participating child. Participants will receive a modest shopping voucher to facilitate retention. Associations between oral processing behaviors, physiological responses, and weight status will be examined using multivariable regression models. Exploratory mediation analyses will be conducted to assess whether ghrelin and satiety responses partially account for the observed associations.

Conditions

Healhty

Keywords

eating behavior; BMI; Children; Satiety; Body composition

Outcome Measures

Primary Outcomes (2)

• Total energy intake during a meal

  Total energy intake at each meal will be calculated by weighing each food item before and after the meal and determining the energy content of the amount consumed.

  During each test meal, from placement of the meal tray on the table until the participant indicates that they have finished eating and leaves the table (approximately 5-20 minutes; assessed once per test meal).

• Eating duration (minutes and seconds)

  Overall time the participant was eating the test meal.

  Measured during each test meal

Secondary Outcomes (5)

• Total daily energy consumed

  During the 24 hours preceding each of the two test-meal visits.

• Satiety assessment

  Subjective hunger and satiety responses will be evaluated before each test meal, immediately after the meal, and during the postprandial period.

• Postprandial Change in Salivary Ghrelin Concentration

  Immediately before and immediately after each of the two test meals.

• Total numbers of bites

  During each test meal, from placement of the meal tray on the table until the participant indicates that they have finished eating and leaves the table (approximately 5-20 minutes; assessed once per test meal).

• Total number of chews

  During each test meal, from placement of the meal tray on the table until the participant indicates that they have finished eating and leaves the table (approximately 5-20 minutes; assessed once per test meal).

Study Arms (2)

Sequence A-B

EXPERIMENTAL

Participants will receive Test Meal A during the first study visit and Test Meal B during the second study visit, following the specified washout period.

Other: Test meal B; Other: Test meal A

Sequence B-A

EXPERIMENTAL

Participants will receive Test Meal B during the first study visit and Test Meal A during the second study visit, following the specified washout period.

Other: Test meal B; Other: Test meal A

Interventions

Test meal A OTHER

A typical Medittarenean breakfast with a soft texture including: Bread, flat omlet, grated carot, sliced cucamber, apple puree and a banana

Sequence A-B; Sequence B-A

Test meal B OTHER

A standardized Mediterranean-style breakfast consisting of bread, a thin omelet, grated carrot, sliced cucumber, apple purée, and a banana.

Sequence A-B; Sequence B-A

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 6-11 years and their parents who are fluent in Hebrew or English.

You may not qualify if:

• Children with dietary restrictions due to medical indications, such as celiac disease, inflammatory bowel disease, or other health conditions that may affect their ability to accept identical test meals included in the research.
• Children who are treated with medications for ADD or ADHD.
• Children with recent tooth loss or an oral injury that interferes with their ability to chew or eat normally at the time of assessment.

Sponsors & Collaborators

• Ariel University: lead

Study Sites (1)

Ariel University

Ariel, 7170741, Israel

RECRUITING

Related Publications (3)

• Pearce AL, Cevallos MC, Romano O, Daoud E, Keller KL. Child meal microstructure and eating behaviors: A systematic review. Appetite. 2022 Jan 1;168:105752. doi: 10.1016/j.appet.2021.105752. Epub 2021 Oct 16.

  PMID: 34662600 BACKGROUND

• Santos REA, Silva HJD, da Silva MG, Barbosa DAM, Silva CMM, Azevedo NC, Pinheiro IL, Lopes PEDS, da Silva Aragao R, Ferraz Pereira KN. Food consumption and masticatory performance of normal weight, overweight and obese children aged 7 to 12 years old. Physiol Behav. 2023 May 15;264:114141. doi: 10.1016/j.physbeh.2023.114141. Epub 2023 Mar 3.

  PMID: 36870382 BACKGROUND

• Crabtree DR, Buosi W, Fyfe CL, Horgan GW, Holst JJ, Johnstone AM; Full4Health-study Group. Salivary ghrelin response to drinks varying in protein content and quantity and association with energy intake and appetite. Physiol Behav. 2021 Dec 1;242:113622. doi: 10.1016/j.physbeh.2021.113622. Epub 2021 Oct 12.

  PMID: 34653498 BACKGROUND

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because the test meals differ in appearance and composition, participants and personnel administering the meals cannot be masked. Outcome assessors will remain unaware of the test-meal allocation. Study visits, samples, and outcome data will be identified using coded labels that do not disclose the meal type, and assessors will not have access to the allocation key until outcome assessment and data entry have been completed.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Nutrition Sciences

Model Details: The study is a crossover trial and all outcomes will be compared between each meal and every other meal. The meal order will be random. Meals will be similar in energy content and differ by the level of chewiness. Each test meal will be served at a different visit to the study laboratory, separated by a week to two weeks from the prior visit. Parents will complete sociodemographic, physical activity, regarding themselves and their children, anthropometrics, salivary Ghrelin and VAS for hunger. Additionally, the child's CEBQ and parent and child food intake over the past 24 hours will be recorded through an in-person interview. Following these assessments, the child and parent will receive their first test meal. The second meeting will be scheduled within two weeks of the first meeting, on a different weekday, to introduce variability in the 24-hour food recall data. The second test meal will be given. All meals will be weighed using UEM and the visit will be audio and video recorded

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)