Status:
COMPLETED
Neuro-Nutrition to Support Physiological Function and Cognitive Skills in People With Down Syndrome, Autism Spectrum Disorder, and ADHD
Lead Sponsor:
Elizabeth Guadalupe Ibarra Coronado
Collaborating Sponsors:
Universidad Nacional Autonoma de Mexico
Conditions:
Down Syndrome
Autism Spectrum Disorder
Eligibility:
All Genders
2-35 years
Phase:
NA
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,...
Detailed Description
The Neuroalimentación protocol integrates dietary modification and targeted nutritional supplementation to support metabolic, cognitive, and physiological functions in populations with neurodevelopmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT07165509
Start Date
March 26 2022
End Date
May 1 2023
Last Update
September 10 2025
Active Locations (1)
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1
Instituto Mexicano de Medicina Integral de Sueño
Mexico City, Mexico, 03100