- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07631195
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
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Carole Tournier, PhD
- Número de telefone: 0033380693077
- E-mail: carole.tournier@inrae.fr
Locais de estudo
-
-
-
Dijon, França, 21000
- Recrutamento
- UMR CSGA
-
Contato:
- Carole Tournier, PhD HDR
- E-mail: carole.tournier@inrae.fr
-
Investigador principal:
- Carole TOURNIER, PhD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / 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)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Oral processing duration (seconds)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Posterior Functional Unit (PFU)
Prazo: 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
Prazo: Baseline (single timepoint only
|
Total number of teeth in the mouth measured from visual assessment
|
Baseline (single timepoint only
|
|
Dental transition stage
Prazo: 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)
Prazo: Baseline (single timepoint only
|
Maximum strength (kPa) measured with the Iowa Oral Pressure Instrument (IOPI)
|
Baseline (single timepoint only
|
|
Masticatory performance (index)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Publicações e links úteis
Publicações Gerais
- Linas N, Peyron MA, Cousson PY, Decerle N, Hennequin M, Eschevins C, Nicolas E, Collado V. Comprehensive Dental Treatment under General Anesthesia Improves Mastication Capability in Children with Early Childhood Caries-A One-Year Follow-Up Study. Int J Environ Res Public Health. 2022 Dec 30;20(1):677. doi: 10.3390/ijerph20010677.
- Barrera LM, Buschang PH, Throckmorton GS, Roldan SI. Mixed longitudinal evaluation of masticatory performance in children 6 to 17 years of age. Am J Orthod Dentofacial Orthop. 2011 May;139(5):e427-34. doi: 10.1016/j.ajodo.2009.08.031.
- Tournier C, Forde CG. Food oral processing and eating behavior from infancy to childhood: evidence on the role of food texture in the development of healthy eating behavior. Crit Rev Food Sci Nutr. 2024 Sep;64(26):9554-9567. doi: 10.1080/10408398.2023.2214227. Epub 2023 Jun 2.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- ID RCB : 2025-A00395-44
- MARELLE Project (Número de outro subsídio/financiamento: Carnot Qualiment)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .