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Could a diet tweak ease autism symptoms? a trial puts three diets to the test

NCT ID NCT07797725

Disease control Sponsor: All India Institute of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether adding a special diet to standard care helps children aged 3 to 8 with autism spectrum disorder. Researchers compare three diets: a low glycemic index diet, a modified Atkins diet, and a gluten-free casein-free diet. The goal is to see if any diet reduces autism severity, measured by a standard scoring tool, after six months. Children continue their usual behavioral, speech, and occupational therapy throughout the study.

What this could mean

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

Active substance
Three dietary interventions: low glycemic index diet, modified Atkins diet, and gluten-free casein-free diet, each added to standard care
What this could lead to
If one diet works better, it could offer a practical, less restrictive dietary option to ease core autism symptoms in children.
What could go wrong
The trial is early and relatively small, and dietary changes can be hard to maintain. Results may not apply to all children with autism.

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

About 123 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

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

3 to 8 years

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: Children aged 3 to 8 years diagnosed with ASD according to DSM -V criteria Exclusion Criteria: 1. ASD in remission : DSM V criteria fulfilled only historically and/or current CARS-2 score \<30 2. Genetic/acquired metabolic disorders including fatty acid oxidation defects, pyruvate carboxylase deficiency, porphyria, diabetes mellitus, dyslipidemia 3. Presence of kidney stones 4. Children with failure to thrive/underweight/stunting, poor oral intake 5. Gastroesophageal reflux 6. Chronic systemic illness: renal/cardiac/hepatic/lung disease, chronic metabolic acidosis, malabsorption 7. Changes in antipsychotic medications over the last 1 month 8. Associated epilepsy 9. Pre-existing food fads 10. Food allergies: to gluten and/or casein, celiac disease 11. Those who have been on Ketogenic diet/ Modified Atkins diet/ Low Glycemic Index Diet / Gluten free and/or Casein free diet in the last 6 months 12. Refusal of consent

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorder

How to take part

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  1. The places running it

    1 site. 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.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • All India Institute of Medical Sciences, New Delhi

    New Delhi, New Delhi, 110029, India

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