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Completed

NCT Number: NCT07165509

Neuro-Nutrition to Support Physiological Function and Cognitive Skills in People With Down Syndrome, Autism Spectrum Disorder, and ADHD

This study aimed to evaluate the impact of a specialized nutritional intervention on physiological performance, sleep quality, and cognitive abilities in individuals with neurodevelopmental disorders, specifically Down syndrome, autism spectrum disorders (ASD), and attention deficit disorder (ADD/ADHD). The intervention consisted of a modified diet protocol combined with an investigational nutritional formulation administered over a fixed intervention period. Outcomes included cognitive performance measures, sleep parameters, and selected physiological biomarkers.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations

Age range

2 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Mexicano de Medicina Integral de Sueño

Mexico City, 03100, Mexico

About this study

The Neuroalimentación protocol integrates dietary modification and targeted nutritional supplementation to support metabolic, cognitive, and physiological functions in populations with neurodevelopmental conditions. This interventional study was conducted as a longitudinal, prospective trial including participants diagnosed with Down syndrome, autism spectrum disorders, or ADHD. Participants received the intervention for a defined period, during which outcomes related to cognitive performance, physiological markers, and sleep quality were evaluated using standardized neuropsychological tests, polysomnography, and laboratory analyses.

The trial sought to determine whether such dietary and supplementation strategies could enhance functional performance and quality of life in these populations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T-2 Nutritional Supplement

Dietary Supplement

Nutritional supplement labeled "T-2"; dose 23 g twice daily, as specified in the protocol. Used only in the arm "T-2 Supplement + Structured Diet."

Other names: Complemento Alimenticio T-2, T-2

Structured Dietary Program

Behavioral

Rigorous, structured dietary intervention applied according to the study protocol. Used in the arms "T-2 Supplement + Structured Diet" and "Structured Diet Only."

Other names: Structured Diet, Neuro-Nutrition Diet Program

Primary outcomes

  1. Change in Executive Function (BRIEF Global Executive Composite [GEC] T-score)

    Time frame: Baseline to 12 months

    Parent/caregiver-rated BRIEF; Global Executive Composite (GEC) T-score (normative mean 50, SD 10). Change is calculated as follow-up minus baseline; unit: T-score.

Secondary outcomes

  1. Change in NEUROPSI Attention and Memory Total Standardized Score

    Time frame: Baseline to 12 months

    NEUROPSI Attention and Memory battery; standardized total score covering verbal/visual short- and long-term memory, episodic memory, attention/concentration, and motor skills; unit: standardized score/percentile per test manual.

Other outcomes

  1. Sleep Efficiency Index (%) by Overnight Polysomnography

    Time frame: Baseline to 12 months

    Overnight polysomnography (≥8 h) recording EEG, EOG, EMG, airflow, respiratory effort, oximetry, etc. Sleep Efficiency Index defined as total sleep time divided by time in bed/recording × 100; unit: percent.

  2. Apnea-Hypopnea Index (events/hour) by Polysomnography

    Time frame: Baseline to 12 months

    Number of respiratory alterations during sleep divided by total sleep time; unit: events/hour.

  3. LDL Cholesterol (mg/dL)

    Time frame: Baseline to 12 months

    Fasting serum low-density lipoprotein cholesterol from standard blood chemistry panel; unit: mg/dL.

  4. C-Reactive Protein (mg/L)

    Time frame: Baseline to 12 months

    Serum C-reactive protein as a marker of systemic inflammation; unit: mg/L.

  5. Conners Parent Rating Scale-Revised: Hyperactivity Index T-score

    Time frame: Baseline to 12 months

    80-item parent-rated scale; Hyperactivity Index T-score per test manual; unit: T-score.

Sponsors and collaborators

Lead sponsor

Elizabeth Guadalupe Ibarra Coronado

Network

Collaborators

  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

Neuro-Nutrition as Support for Physiological Function and Cognitive Abilities in Individuals With Down Syndrome, Autism Spectrum Disorder, and Attention-Deficit/Hyperactivity Disorder

Acronym: NEURODIET-DSAA

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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