Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children

Обзор

The purpose of this study is to define the effects of different inclusions in infant cereals on the adaptation of oral motor behavior and skills displayed at a given age.

Вмешательства

• Другое A
  Control: base infant rice-based cereal with no added sugar
• Другое B
  Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 1 for 6-8 months age group; type 4 for 8-12 months age group; type 4 for 12-18 months age group; type 9 for 18-24 months age group.
• Другое C
  Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 2 for 6-8 months age group; type 5 for 8-12 months age group; type 6 for 12-18 months age group; type 10 for 18-24 months age group.
• Другое D
  Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 3 for 6-8 months age group; type 6 for 8-12 months age group; type 8 for 12-18 months age group; type 11 for 18-24 months age group.
• Другое E
  Test product: base infant rice-based cereal with age appropriate inclusions. Inclusion type 7 for 8-12 months and 18-24 months age groups. Not applicable for 6-8 months and 18-24 months age group.

Первичные конечные точки

• Effects of different inclusions in infant cereals on the number of chews according to the age group. [Срок оценки: Immediately after the product intake]

Вторичные конечные точки (10)

• Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group. [Срок оценки: Immediately after the product intake]
• Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group. [Срок оценки: Immediately after the product intake]
• Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group. [Срок оценки: Immediately after the product intake]
• Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group. [Срок оценки: Immediately after the product intake]
• Associations between inclusion properties and oral motor movement according to age group. [Срок оценки: Immediately after the product intake]
• Associations between inclusion properties and oral motor movement according to age group. [Срок оценки: Immediately after the product intake]
• Impact of inclusions on food acceptance during consumption of infant cereals according to age group. [Срок оценки: Immediately after the product intake]
• Impact of inclusions on food acceptance during consumption of infant cereals according to age group. [Срок оценки: Immediately after the product intake]
• Impact of inclusions on food acceptance during consumption of infant cereals according to age group. [Срок оценки: Immediately after the product intake]
• Impact of inclusions on food liking during consumption of infant cereals according to age group. [Срок оценки: Immediately after the product intake]

Критерии участия

Критерии включения

• Children between 6 months (182 days) to 24 months (730 days) of age (from enrollment to last visit):

1.1. \[182-242\]-days of age from V1 to last visit for the 6-8-month-old age group 1.2. \[243-364\]-days of age from V1 to last visit for the 8-12-month-old age group 1.3. \[365-547\]-days of age from V1 to last visit for the 12-18-month-old age group 1.4. \[548-730\]-days of age from V1 to last visit for the 18-24-month-old age group

• Singleton, full-term infants (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
• Healthy children based on medical history as reported by parent(s) / LAR(s).
• Sit upright with or without support (such as, sitting with back against a chair or while being held) as reported by parent(s) / LAR(s)
• Keep head steady when in a supported position
• Have already started complementary feeding as recommended by their health care professional (have started solid food beyond breastmilk or infant formula)
• Written informed consent is obtained from at least one parent(s) / LAR(s).
• Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity.
• Parent(s) / LAR(s) must understand the informed consent and other study documents.
• Parent(s) / LAR(s) are willing and able to fulfill the requirements of the study protocol within the study timeframe.

Критерии исключения

• 1\. Infant's parents or LARs have not reached legal age of majority (18 years) 2. Children with history of oral/facial malformations or surgery (i.e. cleft lip, cleft palate, tongue-tie/ankyloglossia), or history of tube feeding for any reason.

3\. Children with any chronic illness, congenital malformations (e.g., esophageal or intestinal atresia), surgical sequela (e.g., short bowel syndrome), gastroesophageal reflux disease, behavioral disorders, neurodevelopmental delay or illness that impacts feeding. \[children with an acute illness, such as a cold, gastroenteritis etc. can be included but can only attend the visits once they have recovered\].

4\. Children with feeding or swallowing difficulties/disorders, history of choking, or at high risk of choking.

5\. Child or sibling(s) who has known or suspected food allergy or intolerance, such as cows' milk protein allergy, celiac disease, lactose intolerance, soy allergy, fish allergy, or any other suspected or confirmed food allergies or intolerance.

6\. Children with undernutrition as determined by age-group weight threshold (based on parental reports): weight at \[6-8\[month < 6 kg; weight at \[8-12\[months: < 6.5 kg; weight at \[12-18\[months: < 7.5 kg; weight at \[18-24\] months: < 8.5 kg.

7\. Child is currently participating in or has participated in another intervention clinical study that impacts study outcomes within 4 weeks prior to enrolment or has participated in another age group of this study.

8\. Family or hierarchical relationships with the research team members.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Испания · 2 центра

• Instituto DYM S.A. — Barcelona
• Institute of Agrochemistry & Food Technology CSIC — Valencia

Идентификаторы

NCT: NCT07318506 · 2506INF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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