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

Elizabeth Guadalupe Ibarra Coronado

Status

Completed

Conditions

Autism Spectrum Disorder

Down Syndrome

Attention Deficit Hyperactivity Disorder (ADHD)

Treatments

Behavioral: Structured Dietary Program

Dietary Supplement: T-2 Nutritional Supplement

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT07165509

CEI-000002-43

157118 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

76 patients

Sex

All

Ages

2 to 35 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

76 participants in 3 patient groups

T-2 Supplement + Structured Diet

Experimental group

Description:

Participants receive the T-2 nutritional supplement (23 g twice daily) plus a structured dietary program. Arms run in parallel within each diagnostic cohort (Down syndrome, ASD, ADHD).

Treatment:

Dietary Supplement: T-2 Nutritional Supplement

Behavioral: Structured Dietary Program

Structured Diet Only

Active Comparator group

Description:

Participants follow the structured dietary intervention without the T-2 supplement.

Treatment:

Behavioral: Structured Dietary Program

Control

No Intervention group

Description: