Could a mediterranean diet ease picky eating in autism?

NCT ID NCT04652388

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
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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Status unknown
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First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Many children with autism are picky eaters, often refusing fruits, vegetables, and proteins, which can lead to poor nutrition and obesity. This trial tests whether nutritional counseling focused on the Mediterranean diet can help these children become less selective and adopt healthier eating habits. The study enrolls children aged 2 to 5 years with an autism diagnosis and food selectivity. Researchers will measure changes in food preferences, diet quality, and eating patterns over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nutritional counseling focused on the Mediterranean diet
What this could lead to
If it works, this could offer a practical, non-drug way to help children with autism eat a wider variety of foods and improve their overall nutrition.
What could go wrong
This is a small, early-stage trial with only 60 children, so results may not apply to all kids with autism. Dietary changes can be hard to sustain, and the study does not measure long-term effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

60 people

The number who actually took part.

Started

Sep 2020

Finished

Sep 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

24 to 60 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * diagnosis of autism spectrum disorders * presence of food selectivity Exclusion Criteria: * Age at enrollment \<24 or\> 60 months. * Concomitant presence of other chronic diseases * epilepsy, * neurological syndromes, * immunodeficiencies, * diabetes, * congenital heart disease, * autoimmune diseases, * inborn errors of metabolism, * tuberculosis, * cystic fibrosis, * chronic respiratory tract diseases, * inflammatory bowel disease, * celiac disease, * eosinophilic pathologies of the gastrointestinal tract, * functional gastrointestinal disorders, * obesity, * tumors, * malnutrition * Major malformations or previous surgery of the gastrointestinal / urinary / respiratory tract.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Naples Federico II

    Naples, Naples, 80131, Italy

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