Institute of Biomedical Technologies-National Research Council, Via Fratelli Cervi, 93 20090, Segrate, MI, Italy.
IRCCS Mondino Foundation, Neuropsychology/Alzheimer's Disease Assessment Unit, Via Mondino 2, 27100, Pavia, Italy.
BMC Geriatr. 2020 Jul 23;20(1):253. doi: 10.1186/s12877-020-01652-2.
Epidemiological evidence suggests that healthy diet is associated with a slowdown of cognitive decline leading to dementia, but the underlying mechanisms are still partially unexplored. Diet is the main determinant of gut microbiota composition, which in turn impacts on brain structures and functions, however to date no studies on this topic are available. The goal of the present paper is to describe the design and methodology of the NutBrain Study aimed at investigating the association of dietary habits with cognitive function and their role in modulating the gut microbiota composition, and brain measures as well.
METHODS/DESIGN: This is a population-based cohort study of community-dwelling adults aged 65 years or more living in Northern Milan, Italy. At the point of presentation people are screened for cognitive functions. Socio-demographic characteristics along with lifestyles and dietary habits, medical history, drugs, functional status, and anthropometric measurements are also recorded. Individuals suspected to have cognitive impairment at the screening phase undergo a clinical evaluation including a neurological examination and a Magnetic Resonance Imaging (MRI) scanning (both structural and functional). Stool and blood samples for the gut microbiota analysis and for the evaluation of putative biological markers are also collected. For each subject with a confirmed diagnosis of Mild Cognitive Impairment (MCI), two cognitively intact controls of the same sex and age are visited. We intend to enrol at least 683 individuals for the screening phase and 240 persons for the clinical assessment.
The NutBrain is an innovative study that incorporates modern and advanced technologies (i.e. microbiome and neuroimaging) into traditional epidemiologic design. The study represents a unique opportunity to address key questions about the role of modifiable risk factors on cognitive impairment, with a particular focus on dietary habits and their association with gut microbiota and markers of the brain-aging process. These findings will help to encourage and plan lifestyle interventions, for both prevention and treatment, aiming at promoting healthy cognitive ageing.
Trial registration number NCT04461951 , date of registration July 7, 2020 (retrospectively registered, ClinicalTrials.gov ).
流行病学证据表明，健康的饮食与认知能力下降的减缓有关，从而降低痴呆的风险，但其中的潜在机制仍部分未知。饮食是肠道微生物群组成的主要决定因素，而肠道微生物群又反过来影响大脑结构和功能，但迄今为止，关于这一主题的研究尚未开展。本文的目的是描述 NutBrain 研究的设计和方法，该研究旨在调查饮食习惯与认知功能的关系，以及它们在调节肠道微生物群组成和大脑测量方面的作用。
方法/设计：这是一项基于人群的队列研究，研究对象为居住在意大利米兰北部的 65 岁及以上的社区居民。在出现时，人们会对认知功能进行筛查。还记录了社会人口特征、生活方式和饮食习惯、病史、药物、功能状态和人体测量数据。在筛查阶段被怀疑有认知障碍的个体接受临床评估，包括神经检查和磁共振成像（MRI）扫描（结构和功能）。还采集粪便和血液样本，用于肠道微生物群分析和评估潜在的生物标志物。对于每一位确诊为轻度认知障碍（MCI）的患者，都会对两名相同性别和年龄的认知正常的对照者进行访问。我们计划在筛查阶段招募至少 683 名参与者，在临床评估阶段招募 240 名参与者。
NutBrain 是一项创新性研究，它将现代和先进的技术（即微生物组和神经影像学）纳入传统的流行病学设计中。该研究为解决与认知障碍相关的可改变风险因素的作用这一关键问题提供了独特的机会，特别是关注饮食习惯及其与肠道微生物群和大脑老化过程标志物的关联。这些发现将有助于鼓励和规划生活方式干预措施，以预防和治疗为目的，促进健康的认知老化。
试验注册号 NCT04461951，注册日期 2020 年 7 月 7 日（回溯注册，ClinicalTrials.gov）。
