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Evolution of Food Oral Processing Behaviours, Food Bolus Formation and Texture Preferences Between 6 to 12 Years Old and Adult Age (MARELLE)

1 de junio de 2026 actualizado por: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Rôle de la Texture Des Aliments et du Comportement Masticatoire Dans Les propriétés du Bol Alimentaire et la Perception Sensorielle Chez Les Enfants d'âge Scolaire (6 à 12 Ans) en Comparaison à un Groupe Adulte

This cross sectional study investigates how the oral physiological changes during the period of dental transition (6-12 years old) influence on texture preferences, food oral processing behaviour and food bolus properties, for different foods varying in texture and in comparison to the adult population.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

Rationale:

Eating behaviour develops during childhood, shaping dietary habits that, in the long term, contribute to growth and health. The development of masticatory function during this period plays an important role in food preferences for different textures and in consumption during meals. Furthermore, chewing transforms food into a bolus for swallowing, and the physical properties of this bolus play a role in digestion and nutrient release. To date, very little data exists on bolus formation in children. The period from 6 to 12 years of age is an important period of maturation of masticatory function, during which the 20 primary teeth are gradually replaced by 28 permanent teeth. The impact of this dental transition on children's eating behavior and nutrition is currently poorly understood.

Objective:

The purposes of this study will to determine (1) how food texture preference, oral processing behaviour and food bolus properties evolve in children during the dental transition period and in comparison to adults (2) how these variables are associated with each other (3) how they are predicted from individual oral physiology (dentition, tongue strength, masticatory performance), food familiarity and parent-reported appetitive traits parameters.

Study design :

Ninety children (n=30 per theoretical stage of mixed dentition (first transitional stage: 6-8 years, inter-transitional stage: 8-10 years, and second transitional stage: 10-12 years)) and 30 adults (25-35 years) will be recruited . Their dentition and oral abilities (tongue strength and masticatory performance) will be characterized. Their oral processing behaviour (duration, number of chews and Oro-sensory exposure time) while consuming different foods (standard pieces of carrot, rice, cheese and biscuit) will be studied using video recordings. Food boluses will then be collected at the time of corresponding to swallowing (swallowing threshold) and characterized for their particles size and number, saliva uptake, and hardness. Texture preferences of all participants, as well as familiarity with the studied foods and the children's appetitive traits will be characterized using questionnaires.

Study population: Healthy children aged 6-8 (n=30), 8-9 (n=30), 10-12 (n=30) years old and 30 adults aged 25-35 years old. Exclusion criteria : dental and orthodontic treatment ongoing

Tipo de estudio

De observación

Inscripción (Estimado)

120

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Francia
      • Dijon, Francia, 21000
        • Reclutamiento
        • UMR CSGA
        • Contacto:
        • Investigador principal:
          • Carole TOURNIER, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Healthy children aged 6-8 (n=30), 8-9 (n=30), 10-12 (n=30) years old and 30 adults aged 25-35 years old.

Descripción

Inclusion Criteria:

  • Being aged between 6 and 12 years old included or between 25 and 35 years old Being consumers of carrot, comté cheese, rice and biscuit

Exclusion Criteria:

  • No French social security coverage
  • Ongoing orthodontic and/or dental treatment
  • Oral motor difficulties
  • Food allergies
  • Diabetes

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
6-7 years
Children aged between 6 and 7 years old included
8-9 years
Children aged between 8 and 9 years old included
10-12 years
Children ages between 10 and 12 years old included
Adults
Adults (25-35 years old)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Oral processing duration (seconds)
Periodo de tiempo: Baseline (single timepoint only)
Oral processing duration (sec) measured with video recording and automated video analysis
Baseline (single timepoint only)
Number of chews (chews/gram)
Periodo de tiempo: Baseline (single timepoint only)
Number of chews measured with video recording and automated video analysis
Baseline (single timepoint only)
Oro-sensory exposure time (second/gram)
Periodo de tiempo: Baseline (single timepoint only)
Oro-sensory exposure time (s/g) measured with video recording and automated video analysis
Baseline (single timepoint only)
Saliva uptake (%) in food bolus
Periodo de tiempo: Baseline (single timepoint only)
Saliva uptake (%) of bolus collected at swallowing, measured from food and bolus mass (g) and dry matter (g)
Baseline (single timepoint only)
Bolus hardness (Newton)
Periodo de tiempo: Baseline (single timepoint only)
Hardness (N) of bolus collected at swallowing obtained from simple compression test with texturometer compression test
Baseline (single timepoint only)
Average size of bolus particles (mm)
Periodo de tiempo: Baseline (single timepoint only)
Size of the particles (mm) measured from a scan of the bolus diluted in glycerol and automated image analysis
Baseline (single timepoint only)
Number of particles in the food bolus
Periodo de tiempo: Baseline (single timepoint only)
Number of bolus particles measured from a scan of the bolus diluted in glycerol and automated image analysis
Baseline (single timepoint only)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Posterior Functional Unit (PFU)
Periodo de tiempo: Baseline (single timepoint only
Number of teeth stained after biting down on blue paper (3 times) measured by visual assessment
Baseline (single timepoint only
Number of teeth
Periodo de tiempo: Baseline (single timepoint only
Total number of teeth in the mouth measured from visual assessment
Baseline (single timepoint only
Dental transition stage
Periodo de tiempo: Baseline (single timepoint only)
Stage of primary dentition (first transitional stage, inter-transitional stage and second transitional stage) assessed from teeth photographs by dental professionals
Baseline (single timepoint only)
Tongue strength (kPa)
Periodo de tiempo: Baseline (single timepoint only
Maximum strength (kPa) measured with the Iowa Oral Pressure Instrument (IOPI)
Baseline (single timepoint only
Masticatory performance (index)
Periodo de tiempo: Baseline (single timepoint only)
Ability to mix two colored chewing gum after 15 chewing cycles, measured with gum scan and automated image analysis
Baseline (single timepoint only)
BMIz
Periodo de tiempo: Baseline (single timepoint only)
BMI z-scores (BMIz) obtained from body weight (kg; measured using a weighing scale) and height (cm; measured using a stadiometer) transformed into corrected for age and sex according to the WHO child growth reference for school-aged children and adolescents
Baseline (single timepoint only)
Food frequency consumption (child report)
Periodo de tiempo: Baseline (single timepoint only)
Child oral self-report of consumption frequency of offered food consumption ('not at all'; 'from time to time'; 'often'; 'very often')
Baseline (single timepoint only)
Food frequency consumption (parental report)
Periodo de tiempo: Baseline (single timepoint only)
Parent report on the consumption frequency by the child for the offered food. Report collected in questionnaire ('never'; 'less than once a month'; 'two to three times a month'; 'once a week'; 'two to four times a week'; 'once a day'; and 'two or more times a day')
Baseline (single timepoint only)
Food familiarity
Periodo de tiempo: Baseline (single timepoint only)
Oral self-report of the familiarity with the offered food (0 : not familiar/1 : familiar)
Baseline (single timepoint only)
Food chewing difficulty
Periodo de tiempo: Baseline (single timepoint only)
Oral self-report whether the offered foods is or not difficult to eat (0 : not difficult/1 : difficult)
Baseline (single timepoint only)
Food texture preferences
Periodo de tiempo: Baseline (single timepoint only)
Self-report on a food texture preference questionnaire. The questionnaire is composed of 17 pairs of soft/smooth and hard/particulate foods. For each pair, the participant chose the preferred one (forced-choice). Soft/Smooth versions will have a value of 1 and hard/particulate version a value of 2. Cumulation of the values provides a Texture preference index. Higher score means higher preference for textured foods.
Baseline (single timepoint only)
Children chewing abilities
Periodo de tiempo: Baseline (single timepoint only)

Parent-reports of their child chewing abilities using a questionnaire (Schwartz et al., 2021).

The questionnaire is composed of 5 questions. Parents answer by one of the 'yes', 'no' and 'I don't know'. Questions are grouped in two dimensions

: 'difficulty of coping with hard/difficult textures' (higher score means lower difficulty) 'extend to which children chew their food before swallowing' (the higher the score, the better the child chews the food before swallowing)
Baseline (single timepoint only)
Child Eating Behaviour and Appetitive traits
Periodo de tiempo: Baseline (single timepoint only)
Parent-reports on the Child Eating Behaviour Questionnaire (CEBQ) will be used to characterize the appetitive traits of the participants (Wardle et al., 2001). The questionnaire is composed of 35 items. Parent answers to each item using 5- point Likert scale ranging from never (1) to always (5) (never, rarely, sometimes, often, always. The items are then grouped to define 8 dimensions: 'food responsiveness', 'enjoyment of food', 'emotional over-eating', 'desire to drink', 'satiety responsiveness', 'slowness in eating', 'emotional undereating' and 'food fussiness'. Higher scores mean higher behaviours.
Baseline (single timepoint only)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de septiembre de 2025

Finalización primaria (Estimado)

1 de agosto de 2026

Finalización del estudio (Estimado)

1 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

1 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2026

Publicado por primera vez (Actual)

5 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • ID RCB : 2025-A00395-44
  • MARELLE Project (Otro número de subvención/financiamiento: Carnot Qualiment)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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