LAAZ-NPH Clinical Center

项目摘要 营养是人类健康和疾病的中心。然而，我们目前“一刀切”的做法， 临床营养在很大一部分人口中是失败的。个体因素包括遗传、新陈代谢、 生理学、微生物组、行为、内建环境和背景环境都是生物学中固有的变异性的基础。 对饮食的反应。令人兴奋的新研究表明，机器学习算法可以将这种复杂的 并预测人们对特定饮食的反应。如果得到验证，这种创新方法将 在提供个性化营养处方方面提供根本性的改变，以促进健康和治疗 慢性病“营养精准健康（NPH），由我们所有人提供动力”联盟的目标是 从不同的人群中生成丰富的数据库，以开发首个同类饮食预测算法。的 路易斯安那-亚利桑那州营养精准健康中心（LAAZ-NPH）的目标，由路易斯安那州立大学彭宁顿分校组成 巴吞鲁日的生物医学中心（PBRC）、新奥尔良的路易斯安那州立大学健康科学中心（LSUHSC）和NIDDK- 凤凰城的凤凰城临床中心（PIMC）将作为临床中心参加NPH联盟， 招募，登记和保留超过2000名参与者在三个计划的研究模块。在模块1中，2，000 来自路易斯安那州（巴吞鲁日和新奥尔良;各600人）和亚利桑那州的“我们所有人”研究项目 （Phoenix; 800）将入组一项为期10天的前瞻性观察性研究。完成后 模块1，300名符合入组控制喂养的特定合格标准的研究受试者 研究，将参加模块2（PBRC、LSUHSC和PIMC;各100人）和至少100人参加模块3 (PBRC和仅PIMC;各≥50）。模块2是在门诊环境中进行的控制喂养研究， 研究参与者，而模块3是在住院环境中进行的控制喂养研究，至少有100名研究参与者 完成模块1的参与者。模块2和3将采用区组随机化交叉研究设计 评估个体对三次14天等热量饮食干预的反应。三种干预饮食（a 地中海和DASH饮食（MEDASH）的组合;可持续的主要植物性饮食 弹性饮食（FLEX）和高度首选西方饮食（HPWD）将通过7-21天的洗脱期分开 时期我们的主要终点是对标准化混合葡萄糖的餐后血糖反应（PPGR） 通过180分钟内葡萄糖曲线下面积增量测量的进餐耐量试验（MMTT） （AUC 180）。次要终点是心脏代谢健康的生物标志物，包括胰岛素抵抗和 代谢综合征评分。我们拟建的中心收集的丰富数据和生物标本将 用于通知范式转变方法，使大规模提供个性化的饮食 处方，以促进一般健康，延缓心脏代谢疾病，并重要地解决健康 差距。

PROJECT SUMMARY Nutrition is at the epicenter of human health and disease. However, our current “one size fits all” approach to clinical nutrition is failing a large segment of the population. Individual factors including genetics, metabolism, physiology, microbiome, behavior, the built in and contextual environment all underlie the inherent variability in response to diets. Exciting new research shows that machine learning algorithms can integrate this complex information and predict how someone responds to a given diet. If validated, this innovative approach will provide a radical change in the delivery of personalized nutrition prescriptions to promote health and treat chronic diseases. The goal of the “Nutrition for Precision Health (NPH), powered by All of Us” consortium is to generate a rich database from a diverse population to develop a first-of-its-kind diet prediction algorithm. The aim of the Louisiana-Arizona Nutrition for Precision Health Center (LAAZ-NPH), consisting of LSU-Pennington Biomedical (PBRC) in Baton Rouge, LSU-Health Sciences Center (LSUHSC) in New Orleans, and the NIDDK- Phoenix Clinical Center (PIMC) in Phoenix, is to participate in the NPH consortium as a clinical center to recruit, enroll and retain more than 2000 participants in the three planned study modules. In Module 1, 2,000 from the All of Us Research Program in Louisiana (Baton Rouge and New Orleans; 600 each) and Arizona (Phoenix; 800) will be enrolled in a 10-day prospective, observational study. Following the completion of Module 1, 300 study participants who meet specified eligibility criteria for enrollment to the controlled feeding studies, will participate in Module 2 (PBRC, LSUHSC and PIMC; 100 each) and at least 100 in Module 3 (PBRC and PIMC only; ≥50 each). Module 2 is a controlled feeding study in an outpatient setting with 300 study participants while Module 3 is a controlled feeding study in an inpatient setting with at least 100 study participants that completed Module 1. Modules 2 and 3 will use a block randomization cross-over study design to evaluate the individual response to three, 14-day isocaloric diet interventions. The three intervention diets (a combination of the Mediterranean and DASH diet (MEDASH); a sustainable predominantly plant-based Flexitarian diet (FLEX) and a Highly Preferred Western Diet (HPWD) will be separated by a 7-21 day wash out periods. Our primary endpoint is the post-prandial plasma glucose response (PPGR) to a standardized mixed meal tolerance test (MMTT) as measured by the incremental glucose area under the curve over 180 min (AUC180). Secondary endpoints are biomarkers of cardiometabolic health including insulin resistance and a metabolic syndrome score. The rich set of data and biospecimens collected by our proposed center will be used to inform paradigm shifting approaches that enable large-scale delivery of personalized dietary prescriptions to promote general health, delay cardiometabolic diseases, and importantly address health disparities.