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Neuro-Nutrition to Support Physiological Function and Cognitive Skills in People With Down Syndrome, Autism Spectrum Disorder, and ADHD

NCT07165509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

T-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."

BEHAVIORAL

Structured 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 & Collaborators

  • Universidad Nacional Autonoma de Mexico

    collaborator OTHER

  • Elizabeth Guadalupe Ibarra Coronado

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-26
Primary Completion
2022-12-31
Completion
2023-05-01

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07165509 on ClinicalTrials.gov