- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
상세 설명
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
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Carole Tournier, PhD
- 전화번호: 0033380693077
- 이메일: carole.tournier@inrae.fr
연구 장소
-
-
-
Dijon, 프랑스, 21000
- 모병
- UMR CSGA
-
연락하다:
- Carole Tournier, PhD HDR
- 이메일: carole.tournier@inrae.fr
-
수석 연구원:
- Carole TOURNIER, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Oral processing duration (seconds)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Posterior Functional Unit (PFU)
기간: 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
기간: Baseline (single timepoint only
|
Total number of teeth in the mouth measured from visual assessment
|
Baseline (single timepoint only
|
|
Dental transition stage
기간: 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)
기간: Baseline (single timepoint only
|
Maximum strength (kPa) measured with the Iowa Oral Pressure Instrument (IOPI)
|
Baseline (single timepoint only
|
|
Masticatory performance (index)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- ID RCB : 2025-A00395-44
- MARELLE Project (기타 보조금/기금 번호: Carnot Qualiment)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .