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富含色素玉米提取物或玉米淀粉的合生元补充剂对未服用过药物的注意力缺陷多动障碍儿童的行为、认知和神经生理影响:一项随机、双盲、对照临床试验。

Behavioural, cognitive, and neurophysiological effects of a synbiotic supplementation enriched with pigmented corn extract or cornstarch in drug-naïve children with attention-deficit hyperactivity disorder: A randomised, double-blind, comparison-controlled clinical trial.

作者信息

Trezzi Sara, Scaccabarozzi Gaia, Nossa Roberta, Piazza Caterina, Bianchi Alessandro Rodolfo, Rosi Eleonora, Tizzoni Federica, Mauri Maddalena, Camillo Laura, Baragetti Andrea, Molteni Massimo, Campanella Vania, Mauro Luca, Cremonesi Paola, Severgnini Marco, Monroy Mariela Mejia, Castiglioni Bianca, Sparvoli Francesca, Pisano Simone, Pozzi Marco, Crippa Alessandro, Nobile Maria

机构信息

Child Psychopathology Unit, Scientific Institute, IRCSS Eugenio Medea, Via Don Luigi Monza 20, Bosisio Parini, LC, Italy.

Bioengineering Lab, Scientific Institute, IRCSS Eugenio Medea, Bosisio Parini, LC, Italy.

出版信息

Clin Nutr ESPEN. 2025 Feb;65:408-417. doi: 10.1016/j.clnesp.2024.12.016. Epub 2024 Dec 20.

DOI:10.1016/j.clnesp.2024.12.016
PMID:39710171
Abstract

BACKGROUND & AIMS: Considerable interest has been recently given to the potential role of the gut-brain axis (GBA) -a two-way communication network between the gut microbiota and the central nervous system- in the pathogenesis of attention-deficit hyperactivity disorder (ADHD), suggesting the potential usefulness of probiotic and synbiotic supplementations. In light of the limited available evidence, synbiotic efficacy in ADHD children not taking medications should be clarified. This study aimed to investigate the efficacy of a synbiotic dietary supplementation on fatty acids levels as well as on microbiota composition, behaviour, cognition, and brain function in children with ADHD.

METHODS

A total of 41 drug-naïve school-aged children diagnosed with ADHD were enrolled in a 3-month randomised, double-blind, comparison-controlled clinical trial, receiving either a synbiotic mix (COMP group) or the same synbiotic mix enriched with an additional extract from pigmented corn (EXP group). Changes in levels of some specific short-chain and branched-chain fatty acids were considered as primary outcomes. Secondary outcome measures included gut microbiota profiling, Child Behaviour Checklist, Conners Parent Rating Scale-revised, computerised cognitive tasks, and haemodynamic response to a Go-NoGo task measured by fNIRS.

RESULTS

No superiority of the EXP synbiotic mix was observed. Analysis of fatty acids did not reveal any significant difference between groups. Children in the COMP group reported a slightly greater improvement than those in the EXP group in focused attention and in the haemodynamic response to a cognitive task.

CONCLUSIONS

This study shows that pigmented corn extract does not enhance the effects of the synbiotic supplementation in ADHD children in terms of fatty acid production, microbiota composition, clinical, cognitive and neurophysiological measures. However, a synbiotic mix of probiotics plus prebiotic acacia fibre and cornstarch could have some promising effects on ADHD symptoms, which warrants further research. Future studies should also continue to explore the potential of fNIRS for monitoring the effects of interventions that target the GBA.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT06005506.

摘要

背景与目的

肠道-脑轴(GBA)是肠道微生物群与中枢神经系统之间的双向通信网络,其在注意力缺陷多动障碍(ADHD)发病机制中的潜在作用最近受到了广泛关注,这表明益生菌和合生元补充剂可能具有一定作用。鉴于现有证据有限,应明确未服用药物的ADHD儿童中合生元的疗效。本研究旨在探讨合生元膳食补充剂对ADHD儿童脂肪酸水平、微生物群组成、行为、认知和脑功能的影响。

方法

共有41名未服用药物的学龄期ADHD儿童参加了一项为期3个月的随机、双盲、对照临床试验,他们被随机分为两组,分别接受合生元混合物(COMP组)或添加了有色玉米额外提取物的相同合生元混合物(EXP组)。一些特定短链和支链脂肪酸水平的变化被视为主要结局指标。次要结局指标包括肠道微生物群分析、儿童行为检查表、修订后的康纳斯父母评定量表、计算机化认知任务,以及通过功能近红外光谱(fNIRS)测量的对Go-NoGo任务的血流动力学反应。

结果

未观察到EXP合生元混合物具有优势。脂肪酸分析未发现两组之间有任何显著差异。COMP组儿童在注意力集中和对认知任务的血流动力学反应方面的改善略大于EXP组儿童。

结论

本研究表明,就脂肪酸产生、微生物群组成、临床、认知和神经生理学指标而言,有色玉米提取物并不能增强合生元补充剂对ADHD儿童的疗效。然而,益生菌加益生元阿拉伯胶纤维和玉米淀粉的合生元混合物可能对ADHD症状有一些有前景的影响,这值得进一步研究。未来的研究还应继续探索fNIRS在监测针对GBA的干预措施效果方面的潜力。

试验注册

ClinicalTrials.gov:NCT06005506。

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