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Can a nutritional cocktail boost brainpower in neurodevelopmental disorders?

NCT ID NCT07165509

Disease control Sponsor: Elizabeth Guadalupe Ibarra Coronado 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
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 Results may not be published yet.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

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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study tested whether a special diet plus a nutritional supplement called T-2 could improve thinking skills, sleep, and overall health in 76 people with Down syndrome, autism, or ADHD, aged 2 to 35. Participants followed either the diet alone, the diet plus supplement, or no intervention. The main focus was on changes in executive function (like planning and focus) and memory. The goal is to find a safe, supportive way to help manage symptoms without medication.

What this could mean

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

Active substance
T-2 nutritional supplement and a structured dietary program
What this could lead to
If it works, this could point toward a simple nutritional approach to help manage cognitive and behavioral challenges in these conditions.
What could go wrong
This is a small, completed study with no phase designation, so results may not be generalizable. Dietary interventions can be hard to stick with, and benefits may vary widely.

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

76 people

The number who actually took part.

Started

Mar 2022

Finished

May 2023

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

2 to 35 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: * Age 2-35 years at enrollment. * Clinical diagnosis of Down syndrome (DS), Autism Spectrum Disorder (ASD/TEA), or Attention-Deficit/Hyperactivity Disorder (ADHD/TDAH). For DS, written karyotype confirmation; for ASD/ADHD, clinical criteria (DSM) and standardized scales per protocol (e.g., Conners). * Parent/guardian able to provide written informed consent prior to study procedures. * Willingness to comply with the assigned structured diet and/or supplement regimen and study visits. Exclusion Criteria: * Individuals outside 2-35 years or without DS/ASD/ADHD diagnosis. * Healthy volunteers (no target neurodevelopmental condition). * Inability or unwillingness to adhere to the dietary program and/or supplement (the team may request withdrawal for non-adherence as per protocol). * Lack of informed consent from parent/guardian.

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder autism spectrum disorder Down syndrome

As listed by the trial registrant

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

Attention deficit hyperactivity disorder (ADHD) Autism spectrum disorder Down syndrome

Contacts and locations

Locations

  • Instituto Mexicano de Medicina Integral de Sueño

    Mexico City, 03100, Mexico

More trials for these conditions

Other studies related to the condition(s) this trial covers.