Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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.

Studieoversigt

Status

Rekruttering

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Anslået)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Dijon, Frankrig, 21000
        • Rekruttering
        • UMR CSGA
        • Kontakt:
        • Ledende efterforsker:
          • Carole TOURNIER, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oral processing duration (seconds)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Posterior Functional Unit (PFU)
Tidsramme: 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
Tidsramme: Baseline (single timepoint only
Total number of teeth in the mouth measured from visual assessment
Baseline (single timepoint only
Dental transition stage
Tidsramme: 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)
Tidsramme: Baseline (single timepoint only
Maximum strength (kPa) measured with the Iowa Oral Pressure Instrument (IOPI)
Baseline (single timepoint only
Masticatory performance (index)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. september 2025

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ID RCB : 2025-A00395-44
  • MARELLE Project (Andet bevillings-/finansieringsnummer: Carnot Qualiment)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner