How adding different ingredients to infant cereal changes babies' mouth and eating movements

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

See if giving 6–24 month-old babies cereals with different added ingredients changes how they move and use their mouths when eating.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 153 (estimated)
• Ages: 6 Months to 6 Months
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (Industry-sponsored)
• Locations: 2 sites (Barcelona and 1 other locations)
• Trial ID: NCT07318506 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls healthy infants in four age cohorts between 6 and 24 months and gives them one of several infant cereals that differ by the included ingredients. Researchers will observe and compare oral-motor patterns and feeding skills at enrollment and at a final visit timed for each age group. The primary focus is on how the different cereal inclusions influence the adaptation of mouth movements and swallowing behaviors appropriate to the child's age. Results will be compared across the intervention groups to identify patterns linked to specific cereal formulations.

Who should consider this trial

Good fit: Healthy, full-term singleton infants aged 6 to 24 months who were born ≥37 weeks with birth weight 2.5–4.5 kg, have already started complementary feeding, can sit upright and keep their head steady, and meet the study's age-specific visit windows.

Not a fit: Preterm infants, children with low birth weight, diagnosed feeding or oral-motor disorders, those who have not started complementary foods, or children outside the 6–24 month age range are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the findings could inform formulation of infant cereals that better support age-appropriate feeding skills and safer, smoother transitions to solid foods.

How similar studies have performed: Prior research indicates that food texture and composition can influence infants' oral-motor development, so this work builds on existing evidence rather than being entirely novel.

Eligibility criteria

Inclusion Criteria:

1. 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
2. Singleton, full-term infants (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
3. Healthy children based on medical history as reported by parent(s) / LAR(s).
4. 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)
5. Keep head steady when in a supported position
6. Have already started complementary feeding as recommended by their health care professional (have started solid food beyond breastmilk or infant formula)
7. Written informed consent is obtained from at least one parent(s) / LAR(s).
8. Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity.
9. Parent(s) / LAR(s) must understand the informed consent and other study documents.
10. Parent(s) / LAR(s) are willing and able to fulfill the requirements of the study protocol within the study timeframe.

Exclusion Criteria:

* 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.

Where this trial is running

Barcelona and 1 other locations

• Instituto DYM S.A. — Barcelona, Spain (Recruiting)
• Institute of Agrochemistry & Food Technology CSIC — Valencia, Spain (Recruiting)

Study contacts

• Study coordinator: Julia Mauger

Conditions Healthy; Infant and Young Child Feeding