R Jayashree, G Gayathri, N Udayakumar, A Kalpana C
Department of Clinical Nutrition, Sri Ramachandra Faculty of Allied Health sciences, Sri Ramachandra Institute Higher Education and Research, Chennai, India.
Department of Paediatrics, Sri Ramachandra Institute Higher Education and Research, Chennai, India.
MethodsX. 2025 Apr 3;14:103300. doi: 10.1016/j.mex.2025.103300. eCollection 2025 Jun.
Emerging evidence highlights the role of essential amino acids in brain function and behavior modulation, with deficiencies observed in children with autism. Amino acid supplementation appears to be effective in the autism management. This study aims to assess the effect of plant based amino acid intervention on plasma amino acid profile and behavior aspects in children with autism spectrum disorder.
•The study involves parallel, randomized controlled trial that will include 68 children (age 3-6 years) with mild to moderate ASD. Children will be randomly assigned (1:1) to intervention group receiving nutritional intervention or a control group continuing standard care.•The intervention will be carried out over 16 weeks, with a dosage based on the child's weight and dietary needs.•Primary outcomes include changes in plasma amino acid concentrations Secondary outcomes include changes in Childhood Autism Rating Scale (CARS) and Autism Treatment Evaluation Checklist (ATEC) scores which would be measured pre- and post-intervention.
Plasma amino acid levels and behavioral assessments will be compared between the groups to determine the effectiveness of the nutritional intervention in improving symptoms.
This trial seeks to establish a sustainable, non-pharmacological approach to managing autism symptoms. Findings would contribute to autism dietary management strategies and the role of essential amino acids in neurodevelopmental health.
新出现的证据凸显了必需氨基酸在脑功能和行为调节中的作用，自闭症儿童中存在氨基酸缺乏的情况。补充氨基酸似乎对自闭症的管理有效。本研究旨在评估植物性氨基酸干预对自闭症谱系障碍儿童血浆氨基酸谱和行为方面的影响。
• 本研究为平行随机对照试验，将纳入68名3至6岁的轻度至中度自闭症谱系障碍儿童。儿童将被随机分配（1:1）至接受营养干预的干预组或继续接受标准护理的对照组。
• 干预将持续16周，剂量根据儿童体重和饮食需求确定。
• 主要结局包括血浆氨基酸浓度的变化。次要结局包括儿童自闭症评定量表（CARS）和自闭症治疗评估清单（ATEC）得分的变化，这些将在干预前后进行测量。
将比较两组之间的血浆氨基酸水平和行为评估，以确定营养干预改善症状的有效性。
本试验旨在建立一种可持续的、非药物性的自闭症症状管理方法。研究结果将有助于自闭症饮食管理策略以及必需氨基酸在神经发育健康中的作用。
