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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)

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.

Panoramica dello studio

Stato

Reclutamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

120

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Dijon, Francia, 21000
        • Reclutamento
        • UMR CSGA
        • Contatto:
        • Investigatore principale:
          • Carole TOURNIER, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Oral processing duration (seconds)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Posterior Functional Unit (PFU)
Lasso di tempo: 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
Lasso di tempo: Baseline (single timepoint only
Total number of teeth in the mouth measured from visual assessment
Baseline (single timepoint only
Dental transition stage
Lasso di tempo: 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)
Lasso di tempo: Baseline (single timepoint only
Maximum strength (kPa) measured with the Iowa Oral Pressure Instrument (IOPI)
Baseline (single timepoint only
Masticatory performance (index)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

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Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 settembre 2025

Completamento primario (Stimato)

1 agosto 2026

Completamento dello studio (Stimato)

1 agosto 2026

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ID RCB : 2025-A00395-44
  • MARELLE Project (Altro numero di sovvenzione/finanziamento: Carnot Qualiment)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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