Baby cereal study: does texture teach tots to chew better?

NCT ID NCT07318506

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Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding different textures to infant rice cereal helps babies aged 6 to 24 months develop better chewing and mouth movements. About 153 healthy infants will be split into groups, each receiving cereal with specific textures suited to their age. Researchers will video-record feeding sessions to count chews and analyze oral motor patterns.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 153 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 6 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Institute of Agrochemistry & Food Technology CSIC

    RECRUITING

    Valencia, 46980, Spain

  • Instituto DYM S.A.

    RECRUITING

    Barcelona, 08037, Spain

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