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. ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01AG022132-02S1
Application #
6797663
Study Section
Special Emphasis Panel (ZAG1)
Program Officer
Romashkan, Sergei
Project Start
2002-09-30
Project End
2009-08-31
Budget Start
2003-09-15
Budget End
2004-08-31
Support Year
2
Fiscal Year
2003
Total Cost
$154,000
Indirect Cost
Name
Duke University
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Redman, Leanne M; Smith, Steven R; Burton, Jeffrey H et al. (2018) Metabolic Slowing and Reduced Oxidative Damage with Sustained Caloric Restriction Support the Rate of Living and Oxidative Damage Theories of Aging. Cell Metab 27:805-815.e4
Das, Sai Krupa; Roberts, Susan B; Bhapkar, Manjushri V et al. (2017) Body-composition changes in the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE)-2 study: a 2-y randomized controlled trial of calorie restriction in nonobese humans. Am J Clin Nutr 105:913-927
Most, Jasper; Tosti, Valeria; Redman, Leanne M et al. (2017) Calorie restriction in humans: An update. Ageing Res Rev 39:36-45
Racette, Susan B; Rochon, James; Uhrich, Mary L et al. (2017) Effects of Two Years of Calorie Restriction on Aerobic Capacity and Muscle Strength. Med Sci Sports Exerc 49:2240-2249
Villareal, Dennis T; Fontana, Luigi; Das, Sai Krupa et al. (2016) Effect of Two-Year Caloric Restriction on Bone Metabolism and Bone Mineral Density in Non-Obese Younger Adults: A Randomized Clinical Trial. J Bone Miner Res 31:40-51
Rochon, James; Bhapkar, Manjushri; Pieper, Carl F et al. (2016) Application of the Marginal Structural Model to Account for Suboptimal Adherence in a Randomized Controlled Trial. Contemp Clin Trials Commun 4:222-228
Meydani, Simin N; Das, Sai K; Pieper, Carl F et al. (2016) Long-term moderate calorie restriction inhibits inflammation without impairing cell-mediated immunity: a randomized controlled trial in non-obese humans. Aging (Albany NY) 8:1416-31
Romashkan, Sergei V; Das, Sai Krupa; Villareal, Dennis T et al. (2016) Safety of two-year caloric restriction in non-obese healthy individuals. Oncotarget 7:19124-33
Martin, Corby K; Bhapkar, Manju; Pittas, Anastassios G et al. (2016) Effect of Calorie Restriction on Mood, Quality of Life, Sleep, and Sexual Function in Healthy Nonobese Adults: The CALERIE 2 Randomized Clinical Trial. JAMA Intern Med 176:743-52
McGarrah, Robert W; Craig, Damian M; Haynes, Carol et al. (2016) High-density lipoprotein subclass measurements improve mortality risk prediction, discrimination and reclassification in a cardiac catheterization cohort. Atherosclerosis 246:229-35

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