LAAZ-NPH Clinical Center

LAAZ-NPH 临床中心

基本信息

批准号：
10385934
负责人：
Clifton Bogardus
金额：
$ 109.67万
依托单位：
LSU PENNINGTON BIOMEDICAL RESEARCH CTR
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-12-10 至 2026-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10385934
关键词：
Address African American All of Us Research Program Area Under Curve Arizona Behavior Behavioral Biological Biological Markers Blood Cardiometabolic Disease Catalogs Chronic Disease Clinical Nutrition Clinical Research Collection Complex Cross-Over Studies DASH diet Data Data Set Databases Diet Dietary Assessment Dietary Intervention Dietary intake Disease Domiciles Effectiveness Eligibility Determination Enrollment Environment Fatty acid glycerol esters Feces Food Genetic Glucose Goals Hair Health Health Promotion Health Sciences Health behavior Heterogeneity Hispanic Americans Human Hybrids Individual Inpatients Insulin Resistance Investigation Louisiana Measures Mediterranean Diet Metabolic Metabolic syndrome Metabolism Minority Modernization Molecular National Institute of Diabetes and Digestive and Kidney Diseases Native Americans Observational Study Outpatients Palate Participant Patient Recruitments Pattern Phenotype Photography Physical activity Physiology Plants Plasma Population Population Heterogeneity Positioning Attribute Precision Health Proteins Protocols documentation Randomized Research Research Design Research Personnel Saliva Sampling Site Specific qualifier value Standardization Testing Urine base cardiometabolism clinical center cognitive function design dietary doubly-labeled water ethnic diversity experience feeding glucose monitor gut microbiota health disparity individual response innovation inter-individual variation machine learning algorithm microbiome novel nutrition precision nutrition prediction algorithm primary endpoint prospective randomized trial recruit response retention rate secondary endpoint stable isotope western diet

项目摘要

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.

项目摘要营养是人类健康和疾病的中心。但是，我们目前的“一件尺寸适合所有人”的方法临床营养失败了大部分人群。包括遗传学，代谢，包括个人因素，生理学，微生物组，行为，内置和上下文环境都在于继承的可变性对饮食的反应。令人兴奋的新研究表明，机器学习算法可以整合这个复合物信息并预测某人如何应对给定的饮食。如果得到验证，这种创新的方法将在提供个性化营养处方以促进健康和治疗方面提供了根本性的变化慢性疾病。 “精确健康营养（NPH）的目标，由我们所有人驱动”的联盟是从潜水员人群中产生丰富的数据库，以开发出一种首先的饮食预测算法。这路易斯安那 - 阿里济此的目的是Precision Health Center（LAAZ-NPH），由LSU-Pennington组成 Baton Rouge的生物医学（PBRC），新奥尔良LSU-Health Sciences Center（LSUHSC）和Niddk-- 凤凰城的凤凰临床中心（PIMC）将参加NPH财团作为临床中心招募，入学和留住三个计划的研究模块中的2000多名参与者。在第1个模块中，2,000 来自路易斯安那州的所有研究计划（巴吞鲁日和新奥尔良；各自的600个）和亚利桑那州（Phoenix; 800）将参加为期10天的前瞻性观测研究。完成后 1，300个研究参与者符合指定的资格标准，以注册为受控喂养研究将参与模块2（PBRC，LSUHSC和PIMC；每个100），在模块3中至少100 （仅PBRC和PIMC；每个≥50）。模块2是一项在门诊环境中的受控喂养研究，300 研究参与者虽然模块3是在住院环境中至少100个研究的住院环境中的一项受控喂养研究完成模块1。模块2和3的参与者将使用块随机化跨界研究设计评估对三，14天的等饮食干预措施的个人反应。三种干预饮食（a 地中海和破折号饮食（Medash）的结合；可持续的主要基于植物的柔韧性饮食（FLEX）和高度首选的西方饮食（HPWD）将通过7-21天洗涤时期。我们的主要终点是派生后血浆葡萄糖反应（PPGR）对标准化的混合餐耐受性测试（MMTT）通过曲线下的增量葡萄糖区域测量180分钟（AUC180）。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A 代谢综合征得分。我们拟议中心收集的丰富数据和生物测量集将是用于告知范式转移方法，以便大规模提供个性化的饮食处方以促进一般健康，延迟心脏代谢疾病，并重要地解决健康差异。