Coordinating Center for CALERIE

CALERIE 协调中心

• 批准号: 7168067
• 负责人: JAMES ROCHON
• 金额: $ 6.29万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7168067
• 关键词: adult human (21+); bioenergetics; biomedical facility; body composition; body physical activity; bone density; caloric dietary content; cardiovascular function; clinical research; cooperative study; data collection methodology /evaluation; data management; dietary restriction; disease /disorder prevention /control; disease /disorder proneness /risk; endocrine gland /system; experimental designs; glucose metabolism; immune system; information dissemination; insulin sensitivity /resistance; nutrition of aging; nutrition related tag; patient oriented research; serology /serodiagnosis; statistics /biometry; therapy adverse effect

DESCRIPTION (provided by applicant): The National Institute on Aging (NIA) has funded three sites to conduct studies on the effects of calorie restricted (CR) diets on the aging process. This research program is called the "Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy" (or, CALERIE). It involves exploratory controlled human intervention studies on the effects of CR on physiology, body composition, and risk factors for age-related pathologies. The primary goals of CALERIE are: to gain knowledge about the effects of sustained CR on physiology, metabolism, body composition, risk factors for age-related pathologies and potential adverse effects; and, to gain knowledge of similarities, differences and interactions between CR and physical activity on the above outcomes. Study populations in the CALERIE studies will be non-obese individuals, with a likely age range of 25-60 years. The outcome measures include energy intake and expenditure, physical activity, body composition, endocrine responses, insulin sensitivity/glucose metabolism, cardiovascuIar function, bone density, immune function, quality of life and potential adverse effects of caloric restriction. The Duke Clinical Research Institute proposes to serve as the Coordinating Center for this project. In this role, we will attend to the following functions. (1) Study Coordination and Planning: We will help establish an efficient organizational structure to ensure that all activities advance in a coordinated fashion. (2) Site Management and Monitoring: We will develop a site management and monitoring plan that educates site staff regarding the conduct of clinical studies, provides training on the Protocol, and improves the quality of the data being collected. (3) Data Management Activities: We will apply sophisticated, multi-dimensional system for on-going data collection and generate periodic reports summarizing the execution of the trial. (3) Statistical Analysis: We will provide statistical leadership in the design of these studies; and perform interim and final analyses in an expeditious and timely manner.

描述（由申请人提供）：美国国家老化研究所（NIA）资助了三个地点，以研究限制卡路里（CR）饮食对衰老过程的影响。该研究计划称为“减少能源摄入量的长期影响的全面评估”（或Calerie）。它涉及有关CR对生理学，身体组成和与年龄相关的病理的危险因素的影响的探索性对照人干预研究。 Calerie的主要目标是：了解持续CR对生理学，代谢，身体组成，与年龄相关病理的危险因素的影响以及潜在的不良影响；并且，为了了解相似性，CR与体育活动之间在上述结果上的差异和相互作用。卡尔里研究中的研究人群将是非肥胖个体，年龄范围可能为25-60岁。结果措施包括能量摄入和支出，体育锻炼，身体成分，内分泌反应，胰岛素敏感性/葡萄糖代谢，心脏疾病功能，骨密度，免疫功能，生活质量，生活质量以及热量限制的潜在不良影响。 杜克临床研究所提议作为该项目的协调中心。在这个角色中，我们将关注以下功能。 （1）研究协调和计划：我们将帮助建立有效的组织结构，以确保所有活动都以协调的方式进行。 （2）站点管理和监视：我们将制定一个站点管理和监视计划，该计划对现场人员进行有关临床研究的进行，提供有关协议的培训并提高收集数据的质量。 （3）数据管理活动：我们将应用复杂的多维系统进行持续的数据收集并生成定期报告，总结了试验的执行。 （3）统计分析：我们将在这些研究的设计中提供统计领导；并以迅速，及时的方式进行中期和最终分析。