Neuro-Nutrition as Support for Physiological Function and Cognitive Abilities in Individuals With Down Syndrome, Autism Spectrum Disorder, and Attention-Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in Executive Function (BRIEF Global Executive Composite [GEC] T-score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Structured Diet Only
Participants follow the structured dietary intervention without the T-2 supplement.
干预措施: Structured Dietary Program (Behavioral)
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).
干预措施: T-2 Nutritional Supplement (Dietary Supplement)
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).
干预措施: Structured Dietary Program (Behavioral)
Control
Participants receive no T-2 supplement and no structured dietary program (usual diet).
结局指标
主要结局
Change in Executive Function (BRIEF Global Executive Composite [GEC] T-score)
时间窗: Baseline to 12 months
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.
次要结局
- Change in NEUROPSI Attention and Memory Total Standardized Score(Baseline to 12 months)
研究者
Elizabeth Guadalupe Ibarra Coronado
Associate Research
Grupo de Neuroalimentación