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Neuro-Nutrition as Support for Physiological Function and Cognitive Abilities in Individuals With Down Syndrome, Autism Spectrum Disorder, and Attention-Deficit/Hyperactivity Disorder
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.
Age
2 - 35 years
Sex
ALL
Healthy Volunteers
No
Instituto Mexicano de Medicina Integral de Sueño
Mexico City, Mexico
Start Date
March 26, 2022
Primary Completion Date
December 31, 2022
Completion Date
May 1, 2023
Last Updated
September 10, 2025
76
ACTUAL participants
T-2 Nutritional Supplement
DIETARY_SUPPLEMENT
Structured Dietary Program
BEHAVIORAL
Lead Sponsor
Elizabeth Guadalupe Ibarra Coronado
Collaborators
NCT06290258
NCT05750095
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05874466