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| ID | Type | Description | Link |
|---|---|---|---|
| 157118 | Other Identifier | CONACYT (Mexico) |
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| Name | Class |
|---|---|
| Universidad Nacional Autonoma de Mexico | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Structured Diet Only | Active Comparator | Participants follow the structured dietary intervention without the T-2 supplement. |
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| Control | No Intervention | Participants receive no T-2 supplement and no structured dietary program (usual diet). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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." |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NEUROPSI Attention and Memory Total Standardized Score | NEUROPSI Attention and Memory battery; standardized total score covering verbal/visual short- and long-term memory, episodic memory, attention/concentration, and motor skills; unit: standardized score/percentile per test manual. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency Index (%) by Overnight Polysomnography | Overnight polysomnography (≥8 h) recording EEG, EOG, EMG, airflow, respiratory effort, oximetry, etc. Sleep Efficiency Index defined as total sleep time divided by time in bed/recording × 100; unit: percent. | Baseline to 12 months |
| Apnea-Hypopnea Index (events/hour) by Polysomnography |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Mexicano de Medicina Integral de Sueño | Mexico City | 03100 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12759822 | Background | 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. | |
| 14258950 | Background | MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available. |
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Individual participant data will not be shared because the informed consent approved by the research ethics committee did not authorize secondary sharing or posting of participant-level data. The dataset includes minors and sensitive health information; sharing would require re-consent and/or new ethics approval, which is not feasible for this completed study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Dec 1, 2021 |
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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.
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| 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." |
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Number of respiratory alterations during sleep divided by total sleep time; unit: events/hour. |
| Baseline to 12 months |
| LDL Cholesterol (mg/dL) | Fasting serum low-density lipoprotein cholesterol from standard blood chemistry panel; unit: mg/dL. | Baseline to 12 months |
| C-Reactive Protein (mg/L) | Serum C-reactive protein as a marker of systemic inflammation; unit: mg/L. | Baseline to 12 months |
| Conners Parent Rating Scale-Revised: Hyperactivity Index T-score | 80-item parent-rated scale; Hyperactivity Index T-score per test manual; unit: T-score. | Baseline to 12 months |
| 11875221 | 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. |
| 10439587 | 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. |
| 16617404 | 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. |
| 10382134 | 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. |
| 22261833 | 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. |
| 15975763 | 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. |
| 15077706 | 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. |
| 16119476 | 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. |
| 9711490 | 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. |
| Sep 3, 2025 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D000067877 | Autism Spectrum Disorder |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
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