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

NCT07165509 | Completed

• 2 other identifiers: CEI-000002-43157118
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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, 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

Down Syndrome; Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Trisomy 21; ASD; ADHD; Neuro-nutrition; Structured diet; Dietary supplement; BRIEF; NEUROPSI Attention and Memory; Polysomnography; Sleep efficiency index; Apnea-hypopnea index; LDL cholesterol; C-reactive protein

Outcome Measures

Primary Outcomes (1)

• Change in Executive Function (BRIEF Global Executive Composite [GEC] T-score)

  Parent/caregiver-rated BRIEF; Global Executive Composite (GEC) T-score (normative mean 50, SD 10). Change is calculated as follow-up minus baseline; unit: T-score.

  Baseline to 12 months

Secondary Outcomes (1)

• Change in NEUROPSI Attention and Memory Total Standardized Score

  Baseline to 12 months

Other Outcomes (5)

• Sleep Efficiency Index (%) by Overnight Polysomnography

  Baseline to 12 months

• Apnea-Hypopnea Index (events/hour) by Polysomnography

  Baseline to 12 months

• LDL Cholesterol (mg/dL)

  Baseline to 12 months

Study Arms (3)

T-2 Supplement + Structured Diet

EXPERIMENTAL

Participants receive the T-2 nutritional supplement (23 g twice daily) plus a structured dietary program. Arms run in parallel within each diagnostic cohort (Down syndrome, ASD, ADHD).

Dietary Supplement: T-2 Nutritional Supplement; Behavioral: Structured Dietary Program

Structured Diet Only

ACTIVE COMPARATOR

Participants follow the structured dietary intervention without the T-2 supplement.

Behavioral: Structured Dietary Program

Control

NO INTERVENTION

Participants receive no T-2 supplement and no structured dietary program (usual diet).

Interventions

T-2 Nutritional Supplement DIETARY_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."

Also known as: Complemento Alimenticio T-2, T-2

T-2 Supplement + Structured Diet

Structured Dietary Program BEHAVIORAL

Rigorous, structured dietary intervention applied according to the study protocol. Used in the arms "T-2 Supplement + Structured Diet" and "Structured Diet Only."

Also known as: Structured Diet, Neuro-Nutrition Diet Program

Structured Diet Only; T-2 Supplement + Structured Diet

Eligibility Criteria

• Age: 2 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elizabeth Guadalupe Ibarra Coronado: lead
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Instituto Mexicano de Medicina Integral de Sueño

Mexico City, 03100, Mexico

Location

Related Publications (11)

• Gioia GA, Isquith PK, Retzlaff PD, Espy KA. Confirmatory factor analysis of the Behavior Rating Inventory of Executive Function (BRIEF) in a clinical sample. Child Neuropsychol. 2002 Dec;8(4):249-57. doi: 10.1076/chin.8.4.249.13513.

  PMID: 12759822 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

• First MB, Pincus HA. The DSM-IV Text Revision: rationale and potential impact on clinical practice. Psychiatr Serv. 2002 Mar;53(3):288-92. doi: 10.1176/appi.ps.53.3.288.

  PMID: 11875221 BACKGROUND

• Ostrosky-Solis F, Ardila A, Rosselli M. NEUROPSI: a brief neuropsychological test battery in Spanish with norms by age and educational level. J Int Neuropsychol Soc. 1999 Jul;5(5):413-33. doi: 10.1017/s1355617799555045.

  PMID: 10439587 BACKGROUND

• Allik H, Larsson JO, Smedje H. Sleep patterns of school-age children with Asperger syndrome or high-functioning autism. J Autism Dev Disord. 2006 Jul;36(5):585-95. doi: 10.1007/s10803-006-0099-9.

  PMID: 16617404 BACKGROUND

• Hering E, Epstein R, Elroy S, Iancu DR, Zelnik N. Sleep patterns in autistic children. J Autism Dev Disord. 1999 Apr;29(2):143-7. doi: 10.1023/a:1023092627223.

  PMID: 10382134 BACKGROUND

• Accardo JA, Marcus CL, Leonard MB, Shults J, Meltzer LJ, Elia J. Associations between psychiatric comorbidities and sleep disturbances in children with attention-deficit/hyperactivity disorder. J Dev Behav Pediatr. 2012 Feb;33(2):97-105. doi: 10.1097/DBP.0b013e31823f6853.

  PMID: 22261833 BACKGROUND

• Cotton S, Richdale A. Brief report: parental descriptions of sleep problems in children with autism, Down syndrome, and Prader-Willi syndrome. Res Dev Disabil. 2006 Mar-Apr;27(2):151-61. doi: 10.1016/j.ridd.2004.12.003. Epub 2005 Jun 21.

  PMID: 15975763 BACKGROUND

• Bittles AH, Glasson EJ. Clinical, social, and ethical implications of changing life expectancy in Down syndrome. Dev Med Child Neurol. 2004 Apr;46(4):282-6. doi: 10.1017/s0012162204000441. No abstract available.

  PMID: 15077706 BACKGROUND

• Billstedt E, Gillberg IC, Gillberg C. Autism after adolescence: population-based 13- to 22-year follow-up study of 120 individuals with autism diagnosed in childhood. J Autism Dev Disord. 2005 Jun;35(3):351-60. doi: 10.1007/s10803-005-3302-5.

  PMID: 16119476 BACKGROUND

• Bieberich AA, Morgan SB. Brief report: affective expression in children with autism or Down syndrome. J Autism Dev Disord. 1998 Aug;28(4):333-8. doi: 10.1023/a:1026016804357. No abstract available.

  PMID: 9711490 BACKGROUND

MeSH Terms

Conditions

Down Syndrome; Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Research

Model Details: Three-arm parallel study. Within each diagnostic cohort (Down syndrome, autism spectrum disorder, and ADHD), participants were assigned to one of three groups followed concurrently: (1) T-2 nutritional supplement (23 g twice daily) plus a structured dietary program; (2) structured diet only; or (3) no supplement and no structured diet (control). Age range 2-35 years; no crossover.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: March 26, 2022
• Primary Completion: December 31, 2022
• Study Completion: May 1, 2023
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)