Neuro-Nutrition to Support Physiological Function and Cognitive Skills in People With Down Syndro… (NCT07165509) | Clinical Trial Compass
CompletedNot Applicable
Neuro-Nutrition to Support Physiological Function and Cognitive Skills in People With Down Syndrome, Autism Spectrum Disorder, and ADHD
Mexico76 participantsStarted 2022-03-26
Plain-language 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.
Who can participate
Age range2 Years – 35 Years
SexALL
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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.
What they're measuring
1
Change in Executive Function (BRIEF Global Executive Composite [GEC] T-score)