Neuro-Nutrition to Support Physiological Function and Cognitive Skills in People With Down Syndrome, Autism Spectrum Disorder, and ADHD
NCT ID: NCT07165509
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2022-03-26
2023-05-01
Brief Summary
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Detailed Description
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The trial sought to determine whether such dietary and supplementation strategies could enhance functional performance and quality of life in these populations.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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T-2 Supplement + Structured Diet
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).
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."
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."
Structured Diet Only
Participants follow the structured dietary intervention without the T-2 supplement.
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."
Control
Participants receive no T-2 supplement and no structured dietary program (usual diet).
No interventions assigned to this group
Interventions
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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."
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."
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
2 Years
35 Years
ALL
No
Sponsors
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Universidad Nacional Autonoma de Mexico
OTHER
Elizabeth Guadalupe Ibarra Coronado
NETWORK
Responsible Party
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Elizabeth Guadalupe Ibarra Coronado
Associate Research
Locations
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Instituto Mexicano de Medicina Integral de Sueño
Mexico City, , Mexico
Countries
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References
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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.
MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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157118
Identifier Type: OTHER
Identifier Source: secondary_id
CEI-000002-43
Identifier Type: -
Identifier Source: org_study_id
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