Chewing, Eating Rate, and Weight Status in Children
ConditionHealhty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorAriel University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy children aged 6-11 years and their parents who are fluent in Hebrew or English.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Test meal B
Other interventionA standardized Mediterranean-style breakfast consisting of bread, a thin omelet, grated carrot, sliced cucumber, apple purée, and a banana.
Test meal A
Other interventionA typical Medittarenean breakfast with a soft texture including: Bread, flat omlet, grated carot, sliced cucamber, apple puree and a banana
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Sequence A-BExperimental treatment 2 interventions
Group B: Sequence B-AExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
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).2
Eating duration (minutes and seconds)
Overall time the participant was eating the test meal.
Time frame
Measured during each test mealSecondary outcomes
1
Total daily energy consumed
otal energy intake during the 24 hours preceding each test meal will be estimated separately using participant- and parent-reported consumption of all foods and beverages. Reported quantities will be converted to energy values (kcal) using a nutritional composition database and summed to calculate total 24-hour energy intake.
Time frame
During the 24 hours preceding each of the two test-meal visits.2
Satiety assessment
Satiety will be assessed using validated Visual Analog Scale (VAS) ratings
Time frame
Subjective hunger and satiety responses will be evaluated before each test meal, immediately after the meal, and during the postprandial period.3
Postprandial Change in Salivary Ghrelin Concentration
Salivary ghrelin concentration will be measured using standardized saliva collection and biochemical analysis procedures. The outcome will be calculated as the change in ghrelin concentration from before to after each test meal and reported in pg/mL.
Time frame
Immediately before and immediately after each of the two test meals.4
Total numbers of bites
The total number of bites taken during each test meal will be determined through standardized review and coding of the video recording. A bite will be defined as an occasion on which food enters the participant's mouth.
Time frame
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).Sponsors and contacts
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Source ClinicalTrials.gov