Estimation of Plasma Concentration of L-Carnosine and its Correlation with Core Symptoms of Autism Spectrum Disorder Children: A Pilot Clinical Trial.

IF 3.3 Q2 BIOCHEMISTRY & MOLECULAR BIOLOGY Frontiers in bioscience (Landmark edition) Pub Date : 2024-10-23 DOI:10.31083/j.fbl2910365
Debi Ann Abraham, Udayakumar Narasimhan, Vijayakumar Thangavel Mahalingam, Manikandan Krishnan, Rajanandh Muhasaparur Ganesan, Khang Wen Goh, Ching Siang Tan, Long Chiau Ming, Chrismawan Ardianto
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Abstract

Background: Literature indicates that L-carnosine may be deficient in autism spectrum disorder (ASD) children. The aim of the present study was to estimate the level of L-carnosine in plasma and correlate it with the Autism Treatment Evaluation Checklist (ATEC) and Childhood Autism Rating Scale 2nd Edition, Standard Version (CARS2-ST) scores. To measure L-carnosine level, a bio-analytical method was developed using reverse phase high- liquid chromatography and validated as per International Conference on Harmonization guidelines.

Method: Children were supplemented with L-carnosine (10-15 mg/kg) along with standard care therapies for 2 months. Before and after supplementation, scores on the ATEC, CARS2-ST, BEARS sleep screening tool, 6-item Gastrointestinal Severity Index, and Parental Stress Scale were evaluated, and L-carnosine was measured at the end of the trial.

Results: The calibration curve was linear in the range of 100-600 ng/mL (R2 = 0.998). The level of L-carnosine quantified was 33.7 ± 0.2 ng/mL. There was no significant difference found in any of the outcome measures (p > 0.05).

Conclusions: Despite the fact that L-carnosine is detectable in the blood, it was found to be ineffective in the management of ASD in children.

Clinical trial registration: The study was registered in the Clinical Trial Registry-India, registration number: CTRI/2019/07/020102.

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估算左旋肉碱的血浆浓度及其与自闭症谱系障碍儿童核心症状的相关性:试点临床试验
背景:文献表明,自闭症谱系障碍(ASD)儿童可能缺乏左旋肉碱。本研究旨在估算血浆中左旋肉碱的水平,并将其与自闭症治疗评估核对表(ATEC)和儿童自闭症评定量表第二版标准版(CARS2-ST)的评分相关联。为了测量左旋肉碱的水平,我们采用反相高液相色谱法开发了一种生物分析方法,并根据国际协调会议的指导方针进行了验证:儿童在接受标准护理疗法的同时补充左旋肉碱(10-15 毫克/千克),为期 2 个月。在补充前和补充后,评估了ATEC、CARS2-ST、BEARS睡眠筛查工具、6项胃肠道严重程度指数和家长压力量表的得分,并在试验结束时测量了左旋肉碱:结果:校准曲线在 100-600 纳克/毫升范围内呈线性关系(R2 = 0.998)。左旋肉碱的定量水平为 33.7 ± 0.2 纳克/毫升。任何结果指标均无明显差异(P > 0.05):结论:尽管血液中可检测到左旋肉碱,但它对治疗儿童自闭症无效:该研究已在印度临床试验注册中心注册,注册号为ctri/2019/07/0201:CTRI/2019/07/020102.
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