Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder, Down Syndrome
Conditions
Keywords
Trisomy 21, ASD, ADHD, Neuro-nutrition, Structured diet, Dietary supplement, BRIEF, NEUROPSI Attention and Memory, Polysomnography, Sleep efficiency index, Apnea-hypopnea index, LDL cholesterol, C-reactive protein
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTT-2 Nutritional 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.
BEHAVIORALStructured Dietary Program
Rigorous, structured dietary intervention applied according to the study protocol. Used in the arms T-2 Supplement + Structured Diet and Structured Diet Only.
Sponsors
Universidad Nacional Autonoma de Mexico
Elizabeth Guadalupe Ibarra Coronado
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Three-arm parallel study. Within each diagnostic cohort (Down syndrome, autism spectrum disorder, and ADHD), participants were assigned to one of three groups followed concurrently: (1) T-2 nutritional supplement (23 g twice daily) plus a structured dietary program; (2) structured diet only; or (3) no supplement and no structured diet (control). Age range 2-35 years; no crossover.
Eligibility
Sex/Gender
ALL
Age
2 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Executive Function (BRIEF Global Executive Composite [GEC] T-score) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in NEUROPSI Attention and Memory Total Standardized Score | 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
| Measure | Time frame | Description |
|---|---|---|
| LDL Cholesterol (mg/dL) | Baseline to 12 months | Fasting serum low-density lipoprotein cholesterol from standard blood chemistry panel; unit: mg/dL. |
| Sleep Efficiency Index (%) by Overnight Polysomnography | 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. |
| Conners Parent Rating Scale-Revised: Hyperactivity Index T-score | Baseline to 12 months | 80-item parent-rated scale; Hyperactivity Index T-score per test manual; unit: T-score. |
| C-Reactive Protein (mg/L) | Baseline to 12 months | Serum C-reactive protein as a marker of systemic inflammation; unit: mg/L. |
| Apnea-Hypopnea Index (events/hour) by Polysomnography | Baseline to 12 months | Number of respiratory alterations during sleep divided by total sleep time; unit: events/hour. |
Countries
Mexico
Outcome results
None listed