HealthyICONICNCT07318506
Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children
A study testing A, B and C in people with Healthy and Infant and Young Child Feeding, run by Société des Produits Nestlé (SPN) at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Infant and Young Child Feeding
- What is being tested?
- A, B and C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Nov 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Instituto DYM S.A.
Barcelona, 08037
ESTEFANIA CLAVERO, 34 616433004, ESTEFANIA.CLAVERO@INSTITUTODYM.ES
Laura Laguna Cruañes, DR.
- Recruiting
Institute of Agrochemistry & Food Technology CSIC
Valencia, 46980
Laura Laguna, Dr., laura.laguna@iata.csic.es
Laura Laguna, Dr.
About this study
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.
- Conditions
- Healthy, Infant and Young Child Feeding
- Being tested
- A, B, C, D, E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOther
Control: base infant rice-based cereal with no added sugar
BOther
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.
COther
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.
DOther
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.
EOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A, B, E, C, D | Other | Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| B, C, A, D, E | Other | Cross-over sequence starting by test product B. Test product E is not applicable for 6-8 months and 18-24 months age group. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| C, D, B, E, A | Other | Cross-over sequence.Test product E is not applicable for 6-8 months and 18-24 months age group. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| D, E, C, A, B | Other | Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| E, A, D, B, C | Other | Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| D, C, E, B, A | Other | Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| E, D, A, C, B | Other | Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| A, E, B, D, C | Other | Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| B, A, C, E, D | Other | Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
| C, B, D, A, E | Other | Cross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. Receives: Other: A; Other: B; Other: C; Other: D; Other: E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the product intake
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: Immediately after the product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start5 Nov 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318506
- Sponsor's protocol ID
- 2506INF
- Acronym
- ICONIC
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children
- ClinicalTrials.gov ID
- NCT07318506
- Acronym / sponsor ID
- ICONIC / 2506INF
- Conditions
- Healthy, Infant and Young Child Feeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| A, B, E, C, D | Other | Other: A, Other: B, Other: C, Other: D, Other: ECross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. |
| B, C, A, D, E | Other | Other: A, Other: B, Other: C, Other: D, Other: ECross-over sequence starting by test product B. Test product E is not applicable for 6-8 months and 18-24 months age group. |
| C, D, B, E, A | Other | Other: A, Other: B, Other: C, Other: D, Other: ECross-over sequence.Test product E is not applicable for 6-8 months and 18-24 months age group. |
| D, E, C, A, B | Other | Other: A, Other: B, Other: C, Other: D, Other: ECross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. |
| E, A, D, B, C | Other | Other: A, Other: B, Other: C, Other: D, Other: ECross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. |
| D, C, E, B, A | Other | Other: A, Other: B, Other: C, Other: D, Other: ECross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. |
| E, D, A, C, B | Other | Other: A, Other: B, Other: C, Other: D, Other: ECross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. |
| A, E, B, D, C | Other | Other: A, Other: B, Other: C, Other: D, Other: ECross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. |
| B, A, C, E, D | Other | Other: A, Other: B, Other: C, Other: D, Other: ECross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. |
| C, B, D, A, E | Other | Other: A, Other: B, Other: C, Other: D, Other: ECross-over sequence. Test product E is not applicable for 6-8 months and 18-24 months age group. |
Who may qualify
- Ages
- 6 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AControl: base infant rice-based cereal with no added sugar | Other | A, B, E, C, D, A, E, B, D, C, B, A, C, E, D, B, C, A, D, E, C, B, D, A, E, C, D, B, E, A, D, C, E, B, A, D, E, C, A, B, E, A, D, B, C, E, D, A, C, B |
| BTest 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 | A, B, E, C, D, A, E, B, D, C, B, A, C, E, D, B, C, A, D, E, C, B, D, A, E, C, D, B, E, A, D, C, E, B, A, D, E, C, A, B, E, A, D, B, C, E, D, A, C, B |
| CTest 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 | A, B, E, C, D, A, E, B, D, C, B, A, C, E, D, B, C, A, D, E, C, B, D, A, E, C, D, B, E, A, D, C, E, B, A, D, E, C, A, B, E, A, D, B, C, E, D, A, C, B |
| DTest 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 | A, B, E, C, D, A, E, B, D, C, B, A, C, E, D, B, C, A, D, E, C, B, D, A, E, C, D, B, E, A, D, C, E, B, A, D, E, C, A, B, E, A, D, B, C, E, D, A, C, B |
| ETest 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, B, E, C, D, A, E, B, D, C, B, A, C, E, D, B, C, A, D, E, C, B, D, A, E, C, D, B, E, A, D, C, E, B, A, D, E, C, A, B, E, A, D, B, C, E, D, A, C, B |
Primary outcome
Effects of different inclusions in infant cereals on the number of chews according to the age group.
Time frame: Immediately after the product intake
Define the change in number of chews observed during consumption of infant cereals with or without different inclusions based on manual video coding
10 secondary outcomes
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.
Time frame: Immediately after the product intake
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.
Time frame: Immediately after the product intake
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.
Time frame: Immediately after the product intake
Impact of different inclusions on oral motor movement during consumption of infant cereals according to age group.
Time frame: Immediately after the product intake
Associations between inclusion properties and oral motor movement according to age group.
Time frame: Immediately after the product intake
Associations between inclusion properties and oral motor movement according to age group.
Time frame: Immediately after the product intake
Impact of inclusions on food acceptance during consumption of infant cereals according to age group.
Time frame: Immediately after the product intake
Impact of inclusions on food acceptance during consumption of infant cereals according to age group.
Time frame: Immediately after the product intake
Impact of inclusions on food acceptance during consumption of infant cereals according to age group.
Time frame: Immediately after the product intake
Impact of inclusions on food liking during consumption of infant cereals according to age group.
Time frame: Immediately after the product intake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A, B and C in people with Healthy and Infant and Young Child Feeding, run by Société des Produits Nestlé (SPN) at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Mauger (+41792019835, JULIA.MAUGER@RDLS.NESTLE.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of different inclusions in infant cereals on the number of chews according to the age group. (time frame: Immediately after the product intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.