HealhtyCHEW-KIDSNCT07808983
Chewing, Eating Rate, and Weight Status in Children
A study testing Test meal B and Test meal A in people with Healhty, run by Ariel University at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Healhty
- What is being tested?
- Test meal B and Test meal A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 6-11 years and their parents who are fluent in Hebrew or English.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Ariel University
Ariel, 7170741
Vered Kaufman-Shriqui, PhD, +972587751199, veredks@ariel.ac.il
Tzach Gil, MSc, +972542181440, tzachgil2907@gmail.com
About this study
Official title: The Association of Chewing and Eating Rate With Weight Status Among Children Aged 6-11 Years
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.
Read the detailed description
Objectives Primary Objective: To examine whether there is an association between the eating duration of a standard meal and weight status (as BMI Z-score) among children aged 6-11.
Secondary Objectives:
- To determine whether there is an association between the number of chews of a standard meal and the weight status of children aged 6-11.
- To examine whether there is an association between chewing rate (total weight of food consumed/total eating time) during a standard meal and daily energy intake among children.
- To examine whether there is an association between chewing rate during a standard meal and body composition among children.
- To examine whether there is an association between the eating duration of a standard meal and the reported satiety level of children aged 6-11.
- To examine whether there is an association between the eating duration of a standard meal and total daily energy intake.
- To assess whether the associations between chewing behaviors, eating characteristics, and dietary intake differ between boys and girls.
- To assess the relationship between chewing-related behaviors and salivary ghrelin responses before and after meal consumption.
Study Design and Methodology Study Design: This doctoral project is a randomized, crossover, laboratory-based experimental study conducted among healthy children aged 6-11 years. Participants will attend multiple assessment sessions during which they will consume standardized isocaloric test meals differing only in food texture and chewability characteristics. The crossover design enables within-subject comparison of oral processing responses under different meal conditions while reducing inter-individual variability. All experimental sessions will be conducted under standardized laboratory conditions.
Study Population: The study will include approximately 70 children aged 6-11 years, including those with normal weight and those with obesity, according to World Health Organization BMI-for-age z-score criteria. Children with medical conditions or dietary restrictions that may affect eating behavior, appetite regulation, or food consumption will be excluded. The selected age range represents a critical developmental stage during which eating patterns, satiety regulation, and obesity-related behaviors may still be influenced through behavioral and nutritional interventions.
Primary Outcomes: Primary oral processing variables will include: Chewing duration; Number of chews; Eating duration; Eating rate; Amount of food consumed.
Secondary Outcomes:
- Satiety Assessment: Subjective hunger and satiety responses will be evaluated using validated Visual Analog Scale (VAS) ratings before the meal, immediately after the meal, and during the postprandial period.
Hormonal Assessment: Salivary ghrelin concentrations will be measured before and after test meals using standardized saliva collection and biochemical analysis procedures. Ghrelin was selected due to its established role in appetite regulation and meal-related hunger signaling.
Methods Study Procedure: Participants will consume standardized test meals developed to differ in texture and chewability while maintaining comparable caloric and macronutrient composition. Meals will include foods categorized according to oral processing difficulty and chewing demands. During meal consumption, oral processing behaviors will be objectively assessed using synchronized behavioral and physiological measurement systems. 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.
Meal consumption will be recorded using panoramic video cameras, and chewing-related behaviors will be coded by independent evaluators. In addition, meals will be administered using the Universal Eating Monitor (UEM), a concealed scale-based system that continuously records food intake throughout the meal and enables high-resolution assessment of eating microstructure.
Anthropometric and Body Composition Assessment: Children and parents will undergo standardized measurements of: Weight and height; BMI-for-age z-score/Parental BMI; Body composition using InBody 770; Upper-body muscle strength using JAMAR dynamometry.
Dietary and Behavioral Questionnaires: Additional assessments will include: 24-hour dietary recalls; Physical activity questionnaires; Sociodemographic questionnaire; Children's Eating Behavior Questionnaire (CEBQ) (children only); AUT-EAT questionnaire (to assess eating behaviors and challenges specifically in children on the Autism Spectrum) (children only); parental eating behaviors questionnaire. Parents weight, height and eating behaviors will be recorded during one meal session.
Statistical Analysis: Statistical analyses will be conducted using IBM SPSS Statistics, version 31.0. Descriptive statistics will summarize participant characteristics overall and by weight-status group. Continuous variables will be assessed for normality and presented as means ± SD or medians and interquartile ranges, as appropriate; categorical variables will be presented as frequencies and percentages. Group comparisons will be performed using t tests, Mann-Whitney U tests, chi-square tests, or Fisher's exact tests, as appropriate.
Given the randomized crossover design, primary analyses will use linear mixed-effects models to account for repeated measurements within participants across meal conditions. Models will include participant as a random effect and meal texture, weight status or BMI-for-age z-score, visit order, and relevant covariates, including age, sex, and socioeconomic characteristics, as fixed effects. Interaction terms will be used to examine whether responses to soft versus hard meals differ by weight status or sex.
Primary behavioral outcomes, including eating duration, chewing duration, number of chews, eating rate, and food consumed, will be analyzed in relation to BMI-for-age z-score, body composition, satiety ratings, ghrelin responses, and total daily energy intake. Satiety and salivary ghrelin changes will be examined using repeated-measures models and pre-to-post meal change scores. Parent-child associations in eating behaviors and anthropometric measures will be explored using correlation and regression analyses.
Exploratory mediation analyses will assess whether satiety and ghrelin responses partially explain associations between oral processing behaviors and weight-related outcomes. Model assumptions will be evaluated, and sensitivity analyses will be conducted for missing or extreme values. Statistical significance will be set at p < 0.05, with effect sizes and 95% confidence intervals reported alongside p values.
- Conditions
- Healhty
- Being tested
- Test meal B, Test meal A
- Keywords
- eating behavior, BMI, Children, Satiety, Body composition
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test meal BOther
A standardized Mediterranean-style breakfast consisting of bread, a thin omelet, grated carrot, sliced cucumber, apple purée, and a banana.
Test meal AOther
A typical Medittarenean breakfast with a soft texture including: Bread, flat omlet, grated carot, sliced cucamber, apple puree and a banana
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Test meal B; Other: Test meal A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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: Measured during each test meal
Secondary outcomes (5)
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.
Measured: During the 24 hours preceding each of the two test-meal visits.
Satiety assessment
Satiety will be assessed using validated Visual Analog Scale (VAS) ratings
Measured: 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
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.
Measured: Immediately before and immediately after each of the two test meals.
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.
Measured: 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
The total number of chewing cycles performed during each test meal will be determined through standardized review and coding of the video recording. A chewing cycle will be defined as one complete jaw-closing movement associated with food mastication.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealhtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vered Kaufman Shriqui, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808983
- Sponsor's protocol ID
- AU-HEA-VKS-20250811
- Acronym
- CHEW-KIDS
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the parental consent, participant assent, and ethics approval do not authorize sharing participant-level data outside the research team. Furthermore, the study involves minors and includes sensitive health, dietary, and video-derived data, creating a residual risk of participant identification even after de-identification. Study findings will be reported only in aggregate form.
Publications
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.
PubMed 34662600Santos 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.
PubMed 36870382Crabtree 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.
PubMed 34653498
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Chewing and Eating Rate With Weight Status Among Children Aged 6-11 Years
- ClinicalTrials.gov ID
- NCT07808983
- Acronym / sponsor ID
- CHEW-KIDS / AU-HEA-VKS-20250811
- Conditions
- Healhty
- Keywords
- eating behavior, BMI, Children, Satiety, Body composition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives Primary Objective: To examine whether there is an association between the eating duration of a standard meal and weight status (as BMI Z-score) among children aged 6-11.
Secondary Objectives:
- To determine whether there is an association between the number of chews of a standard meal and the weight status of children aged 6-11.
- To examine whether there is an association between chewing rate (total weight of food consumed/total eating time) during a standard meal and daily energy intake among children.
- To examine whether there is an association between chewing rate during a standard meal and body composition among children.
- To examine whether there is an association between the eating duration of a standard meal and the reported satiety level of children aged 6-11.
- To examine whether there is an association between the eating duration of a standard meal and total daily energy intake.
- To assess whether the associations between chewing behaviors, eating characteristics, and dietary intake differ between boys and girls.
- To assess the relationship between chewing-related behaviors and salivary ghrelin responses before and after meal consumption.
Study Design and Methodology Study Design: This doctoral project is a randomized, crossover, laboratory-based experimental study conducted among healthy children aged 6-11 years. Participants will attend multiple assessment sessions during which they will consume standardized isocaloric test meals differing only in food texture and chewability characteristics. The crossover design enables within-subject comparison of oral processing responses under different meal conditions while reducing inter-individual variability. All experimental sessions will be conducted under standardized laboratory conditions.
Study Population: The study will include approximately 70 children aged 6-11 years, including those with normal weight and those with obesity, according to World Health Organization BMI-for-age z-score criteria. Children with medical conditions or dietary restrictions that may affect eating behavior, appetite regulation, or food consumption will be excluded. The selected age range represents a critical developmental stage during which eating patterns, satiety regulation, and obesity-related behaviors may still be influenced through behavioral and nutritional interventions.
Primary Outcomes: Primary oral processing variables will include: Chewing duration; Number of chews; Eating duration; Eating rate; Amount of food consumed.
Secondary Outcomes:
- Satiety Assessment: Subjective hunger and satiety responses will be evaluated using validated Visual Analog Scale (VAS) ratings before the meal, immediately after the meal, and during the postprandial period.
Hormonal Assessment: Salivary ghrelin concentrations will be measured before and after test meals using standardized saliva collection and biochemical analysis procedures. Ghrelin was selected due to its established role in appetite regulation and meal-related hunger signaling.
Methods Study Procedure: Participants will consume standardized test meals developed to differ in texture and chewability while maintaining comparable caloric and macronutrient composition. Meals will include foods categorized according to oral processing difficulty and chewing demands. During meal consumption, oral processing behaviors will be objectively assessed using synchronized behavioral and physiological measurement systems. 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.
Meal consumption will be recorded using panoramic video cameras, and chewing-related behaviors will be coded by independent evaluators. In addition, meals will be administered using the Universal Eating Monitor (UEM), a concealed scale-based system that continuously records food intake throughout the meal and enables high-resolution assessment of eating microstructure.
Anthropometric and Body Composition Assessment: Children and parents will undergo standardized measurements of: Weight and height; BMI-for-age z-score/Parental BMI; Body composition using InBody 770; Upper-body muscle strength using JAMAR dynamometry.
Dietary and Behavioral Questionnaires: Additional assessments will include: 24-hour dietary recalls; Physical activity questionnaires; Sociodemographic questionnaire; Children's Eating Behavior Questionnaire (CEBQ) (children only); AUT-EAT questionnaire (to assess eating behaviors and challenges specifically in children on the Autism Spectrum) (children only); parental eating behaviors questionnaire. Parents weight, height and eating behaviors will be recorded during one meal session.
Statistical Analysis: Statistical analyses will be conducted using IBM SPSS Statistics, version 31.0. Descriptive statistics will summarize participant characteristics overall and by weight-status group. Continuous variables will be assessed for normality and presented as means ± SD or medians and interquartile ranges, as appropriate; categorical variables will be presented as frequencies and percentages. Group comparisons will be performed using t tests, Mann-Whitney U tests, chi-square tests, or Fisher's exact tests, as appropriate.
Given the randomized crossover design, primary analyses will use linear mixed-effects models to account for repeated measurements within participants across meal conditions. Models will include participant as a random effect and meal texture, weight status or BMI-for-age z-score, visit order, and relevant covariates, including age, sex, and socioeconomic characteristics, as fixed effects. Interaction terms will be used to examine whether responses to soft versus hard meals differ by weight status or sex.
Primary behavioral outcomes, including eating duration, chewing duration, number of chews, eating rate, and food consumed, will be analyzed in relation to BMI-for-age z-score, body composition, satiety ratings, ghrelin responses, and total daily energy intake. Satiety and salivary ghrelin changes will be examined using repeated-measures models and pre-to-post meal change scores. Parent-child associations in eating behaviors and anthropometric measures will be explored using correlation and regression analyses.
Exploratory mediation analyses will assess whether satiety and ghrelin responses partially explain associations between oral processing behaviors and weight-related outcomes. Model assumptions will be evaluated, and sensitivity analyses will be conducted for missing or extreme values. Statistical significance will be set at p < 0.05, with effect sizes and 95% confidence intervals reported alongside p values.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Sequence A-B | Experimental | Other: Test meal B, Other: Test meal AParticipants will receive Test Meal A during the first study visit and Test Meal B during the second study visit, following the specified washout period. |
| Sequence B-A | Experimental | Other: Test meal B, Other: Test meal AParticipants will receive Test Meal B during the first study visit and Test Meal A during the second study visit, following the specified washout period. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children aged 6-11 years and their parents who are fluent in Hebrew or English.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test meal BA standardized Mediterranean-style breakfast consisting of bread, a thin omelet, grated carrot, sliced cucumber, apple purée, and a banana. | Other | Sequence A-B, Sequence B-A |
| Test meal AA typical Medittarenean breakfast with a soft texture including: Bread, flat omlet, grated carot, sliced cucamber, apple puree and a banana | Other | Sequence A-B, Sequence B-A |
Primary outcome
Total energy intake during a meal
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).
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.
Eating duration (minutes and seconds)
Time frame: Measured during each test meal
Overall time the participant was eating the test meal.
5 secondary outcomes
Total daily energy consumed
Time frame: During the 24 hours preceding each of the two test-meal visits.
Satiety assessment
Time frame: 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
Time frame: Immediately before and immediately after each of the two test meals.
Total numbers of bites
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).
Total number of chews
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 34662600Pearce 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.
- Background: PubMed 36870382Santos 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.
- Background: PubMed 34653498Crabtree 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the parental consent, participant assent, and ethics approval do not authorize sharing participant-level data outside the research team. Furthermore, the study involves minors and includes sensitive health, dietary, and video-derived data, creating a residual risk of participant identification even after de-identification. Study findings will be reported only in aggregate form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal B and Test meal A in people with Healhty, run by Ariel University at 1 site in Israel.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total energy intake during a meal (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).). The study lists 2 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 NCT07808983, 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 9 Sep 2026.