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

Elizabeth Guadalupe Ibarra Coronado76 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Down Syndrome

Interventions

T-2 Nutritional SupplementDIETARY_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."

Structured Dietary ProgramBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline to 12 months

Secondary Outcomes

Change in NEUROPSI Attention and Memory Total Standardized Score

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.