CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
T-2 Nutritional Supplement +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07165509
NCT07165509N/ACompleted
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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

Elizabeth Guadalupe Ibarra Coronado·interventional·Posted Sep 10, 2025·Updated Sep 10, 2025

In Brief

A clinical study evaluating T-2 Nutritional Supplement and Structured Dietary Program for Down Syndrome and 2 related conditions. Completed, enrolled 76 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDown Syndrome, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder (ADHD)
CountriesMexico
CollaboratorsUniversidad Nacional Autonoma de Mexico

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 10, 2025
Enrollment StartMar 26, 2022
Primary CompletionDec 31, 2022
Study CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10 months ago

Interventions

T-2 Nutritional Supplementdietary

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."