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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Infant and Young Child Feeding
• Intervention / Treatment: Other: A; Other: B; Other: C; Other: D; Other: E

• Study Type: Interventional
• Enrollment (Estimated): 153
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia Mauger; Phone Number: +41792019835; Email: JULIA.MAUGER@RDLS.NESTLE.COM

Study Locations

• Spain
  • Barcelona, Spain, 08037
    • Recruiting
    • Instituto DYM S.A.
    • Contact: ESTEFANIA CLAVERO; Phone Number: 34 616433004; Email: ESTEFANIA.CLAVERO@INSTITUTODYM.ES
    • Principal Investigator: Laura Laguna Cruañes, DR.
  • Valencia, Spain, 46980
    • Recruiting
    • Institute of Agrochemistry & Food Technology CSIC
    • Contact: Laura Laguna, Dr.; Email: laura.laguna@iata.csic.es
    • Principal Investigator: Laura Laguna, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A, B, E, C, D; Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.	Other: A; Control: base infant rice-based cereal with no added sugar; Other: 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.; Other: 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.; Other: 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.; Other: 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.
Other: B, C, A, D, E; Cross-over sequence starting by test product B. Test product E is not applicable for 6-8 months and 18-24 months age group.	Other: A; Control: base infant rice-based cereal with no added sugar; Other: 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.; Other: 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.; Other: 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.; Other: 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.
Other: C, D, B, E, A; Cross-over sequence.Test product E is not applicable for 6-8 months and 18-24 months age group.	Other: A; Control: base infant rice-based cereal with no added sugar; Other: 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.; Other: 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.; Other: 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.; Other: 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.
Other: D, E, C, A, B; Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.	Other: A; Control: base infant rice-based cereal with no added sugar; Other: 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.; Other: 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.; Other: 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.; Other: 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.
Other: E, A, D, B, C; Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.	Other: A; Control: base infant rice-based cereal with no added sugar; Other: 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.; Other: 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.; Other: 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.; Other: 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.
Other: D, C, E, B, A; Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.	Other: A; Control: base infant rice-based cereal with no added sugar; Other: 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.; Other: 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.; Other: 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.; Other: 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.
Other: E, D, A, C, B; Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.	Other: A; Control: base infant rice-based cereal with no added sugar; Other: 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.; Other: 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.; Other: 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.; Other: 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.
Other: A, E, B, D, C; Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.	Other: A; Control: base infant rice-based cereal with no added sugar; Other: 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.; Other: 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.; Other: 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.; Other: 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.
Other: B, A, C, E, D; Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.	Other: A; Control: base infant rice-based cereal with no added sugar; Other: 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.; Other: 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.; Other: 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.; Other: 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.
Other: C, B, D, A, E; Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group.	Other: A; Control: base infant rice-based cereal with no added sugar; Other: 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.; Other: 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.; Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of different inclusions in infant cereals on the number of chews according to the age group.	Define the change in number of chews observed during consumption of infant cereals with or without different inclusions based on manual video coding	Immediately after the product intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.	Comparer chewing duration extracted from video manual coding and the Baby FaceReader automatically calculated metrics between products with different textures for each age group.	Immediately after the product intake
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.	Comparer chewing rate extracted from video manual coding and the Baby FaceReader automatically calculated metrics between products with different textures for each age group.	Immediately after the product intake
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.	Comparer the observation of tongue lateral movements extracted from video manual coding and the BabyFaceReader automatically calculated metrics between products with different textures for each age group, using a 3 points categorical scale.	Immediately after the product intake
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.	Comparer the observation of rotary chewing motions extracted from video manual coding and the Baby FaceReader automatically calculated metrics between products with different textures for each age group, using a 3 points categorical scale.	Immediately after the product intake
Associations between inclusion properties and oral motor movement according to age group.	Identify specific correlation between product texture sensorial caracteristics data and number of chews for each age group, using Partial Least Squares Regression.	Immediately after the product intake
Associations between inclusion properties and oral motor movement according to age group.	Identify specific correlation between product texture mechanical caracteristics data and number of chews for each age group, using Partial Least Squares Regression.	Immediately after the product intake
Impact of inclusions on food acceptance during consumption of infant cereals according to age group.	Comparer between product textures and according to the age group time to consume 5 spoons	Immediately after the product intake
Impact of inclusions on food acceptance during consumption of infant cereals according to age group.	Comparer between product textures and according to the age group time to consume each individual spoon	Immediately after the product intake
Impact of inclusions on food acceptance during consumption of infant cereals according to age group.	Comparer between product textures and according to the age group occurrence of positive and negative behaviors per session	Immediately after the product intake
Impact of inclusions on food liking during consumption of infant cereals according to age group.	Comparer parents reported liking between product textures for each age group based on the score of liker scale responses (dislike extremely score to like extremely score).	Immediately after the product intake

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fumigant 93
• Other Study ID Numbers: 2506INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No