- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Detailní popis
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
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Carole Tournier, PhD
- Telefonní číslo: 0033380693077
- E-mail: carole.tournier@inrae.fr
Studijní místa
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Dijon, Francie, 21000
- Nábor
- UMR CSGA
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Kontakt:
- Carole Tournier, PhD HDR
- E-mail: carole.tournier@inrae.fr
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Vrchní vyšetřovatel:
- Carole TOURNIER, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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6-7 years
Children aged between 6 and 7 years old included
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8-9 years
Children aged between 8 and 9 years old included
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10-12 years
Children ages between 10 and 12 years old included
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Adults
Adults (25-35 years old)
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Oral processing duration (seconds)
Časové okno: Baseline (single timepoint only)
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Oral processing duration (sec) measured with video recording and automated video analysis
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Baseline (single timepoint only)
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Number of chews (chews/gram)
Časové okno: Baseline (single timepoint only)
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Number of chews measured with video recording and automated video analysis
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Baseline (single timepoint only)
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Oro-sensory exposure time (second/gram)
Časové okno: Baseline (single timepoint only)
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Oro-sensory exposure time (s/g) measured with video recording and automated video analysis
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Baseline (single timepoint only)
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Saliva uptake (%) in food bolus
Časové okno: Baseline (single timepoint only)
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Saliva uptake (%) of bolus collected at swallowing, measured from food and bolus mass (g) and dry matter (g)
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Baseline (single timepoint only)
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Bolus hardness (Newton)
Časové okno: Baseline (single timepoint only)
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Hardness (N) of bolus collected at swallowing obtained from simple compression test with texturometer compression test
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Baseline (single timepoint only)
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Average size of bolus particles (mm)
Časové okno: Baseline (single timepoint only)
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Size of the particles (mm) measured from a scan of the bolus diluted in glycerol and automated image analysis
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Baseline (single timepoint only)
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Number of particles in the food bolus
Časové okno: Baseline (single timepoint only)
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Number of bolus particles measured from a scan of the bolus diluted in glycerol and automated image analysis
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Baseline (single timepoint only)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Posterior Functional Unit (PFU)
Časové okno: Baseline (single timepoint only
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Number of teeth stained after biting down on blue paper (3 times) measured by visual assessment
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Baseline (single timepoint only
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Number of teeth
Časové okno: Baseline (single timepoint only
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Total number of teeth in the mouth measured from visual assessment
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Baseline (single timepoint only
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Dental transition stage
Časové okno: Baseline (single timepoint only)
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Stage of primary dentition (first transitional stage, inter-transitional stage and second transitional stage) assessed from teeth photographs by dental professionals
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Baseline (single timepoint only)
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Tongue strength (kPa)
Časové okno: Baseline (single timepoint only
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Maximum strength (kPa) measured with the Iowa Oral Pressure Instrument (IOPI)
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Baseline (single timepoint only
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Masticatory performance (index)
Časové okno: Baseline (single timepoint only)
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Ability to mix two colored chewing gum after 15 chewing cycles, measured with gum scan and automated image analysis
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Baseline (single timepoint only)
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BMIz
Časové okno: Baseline (single timepoint only)
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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
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Baseline (single timepoint only)
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Food frequency consumption (child report)
Časové okno: Baseline (single timepoint only)
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Child oral self-report of consumption frequency of offered food consumption ('not at all'; 'from time to time'; 'often'; 'very often')
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Baseline (single timepoint only)
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Food frequency consumption (parental report)
Časové okno: Baseline (single timepoint only)
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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')
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Baseline (single timepoint only)
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Food familiarity
Časové okno: Baseline (single timepoint only)
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Oral self-report of the familiarity with the offered food (0 : not familiar/1 : familiar)
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Baseline (single timepoint only)
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Food chewing difficulty
Časové okno: Baseline (single timepoint only)
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Oral self-report whether the offered foods is or not difficult to eat (0 : not difficult/1 : difficult)
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Baseline (single timepoint only)
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Food texture preferences
Časové okno: Baseline (single timepoint only)
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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.
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Baseline (single timepoint only)
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Children chewing abilities
Časové okno: Baseline (single timepoint only)
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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)
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Child Eating Behaviour and Appetitive traits
Časové okno: Baseline (single timepoint only)
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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.
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Baseline (single timepoint only)
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- ID RCB : 2025-A00395-44
- MARELLE Project (Jiné číslo grantu/financování: Carnot Qualiment)
Informace o lécích a zařízeních, studijní dokumenty
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