TY - JOUR
T1 - Design and conduct of the CALERIE study
T2 - Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy
AU - Rochon, James
AU - Bales, Connie W.
AU - Ravussin, Eric
AU - Redman, Leanne M.
AU - Holloszy, John O.
AU - Racette, Susan B.
AU - Roberts, Susan B.
AU - Das, Sai Krupa
AU - Romashkan, Sergei
AU - Galan, Katherine M.
AU - Hadley, Evan C.
AU - Kraus, William E.
N1 - Funding Information:
The study is funded by the National Institute on Aging of the U.S. National Institutes of Health, and the full organizational structure is depicted in Figure 1. There are three clinical sites located at the Pennington Biomedical Research Center, Washington University Medical Center, and Tufts University. The Duke Clinical Research Institute serves as the coordinating center (CC). A steering committee is the main governing body and consists of the principal investigators of the clinical sites and the coordinating center as well as the National Institute on Aging project scientist. Other committees include a planning committee, quality control committee, intervention design and delivery
PY - 2011/1
Y1 - 2011/1
N2 - Background: In a robust and consistent manner, sustained caloric restriction (CR) has been shown to retard the aging process in a variety of animal species. Nonhuman primate studies suggest that CR may have similar effects in longer-lived species. The CALERIE (Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy) research program is the first systematic investigation of CR in nonobese human beings. In the phase 2 study, it is hypothesized that 2 years of sustained CR, involving a 25% reduction of ad libitum energy intake, results in beneficial effects similar to those observed in animal studies. This article presents the design and implementation of this study. Methods: The study is a multicenter, parallel-group, randomized controlled trial. A sample of 225 participants (22.0 ≤ body mass index [BMI] < 28.0 kg/m2) is being enrolled with 2:1 allocation to CR. Results: An intensive dietary and behavioral intervention was developed to achieve 25% CR and sustain it over the 2 years. Adherence is monitored using a doubly labeled water technique. Primary outcomes are resting metabolic rate and core temperature, and are assessed at baseline and at 6-month intervals. Secondary outcomes address oxyradical formation, cardiovascular risk markers, insulin sensitivity and secretion, immune function, neuroendocrine function, quality of life and cognitive function. Biologic materials are stored in a central repository. Conclusions: An intricate protocol has been developed to conduct this study. Procedures have been implemented to safeguard the integrity of the data and the conclusions drawn. The results will provide insight into the detrimental changes associated with the human aging process and how CR mitigates these effects.
AB - Background: In a robust and consistent manner, sustained caloric restriction (CR) has been shown to retard the aging process in a variety of animal species. Nonhuman primate studies suggest that CR may have similar effects in longer-lived species. The CALERIE (Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy) research program is the first systematic investigation of CR in nonobese human beings. In the phase 2 study, it is hypothesized that 2 years of sustained CR, involving a 25% reduction of ad libitum energy intake, results in beneficial effects similar to those observed in animal studies. This article presents the design and implementation of this study. Methods: The study is a multicenter, parallel-group, randomized controlled trial. A sample of 225 participants (22.0 ≤ body mass index [BMI] < 28.0 kg/m2) is being enrolled with 2:1 allocation to CR. Results: An intensive dietary and behavioral intervention was developed to achieve 25% CR and sustain it over the 2 years. Adherence is monitored using a doubly labeled water technique. Primary outcomes are resting metabolic rate and core temperature, and are assessed at baseline and at 6-month intervals. Secondary outcomes address oxyradical formation, cardiovascular risk markers, insulin sensitivity and secretion, immune function, neuroendocrine function, quality of life and cognitive function. Biologic materials are stored in a central repository. Conclusions: An intricate protocol has been developed to conduct this study. Procedures have been implemented to safeguard the integrity of the data and the conclusions drawn. The results will provide insight into the detrimental changes associated with the human aging process and how CR mitigates these effects.
KW - Aging
KW - Caloric restriction
KW - Markers of inflammation
KW - Randomized controlled trial
KW - Resting metabolic rate
UR - http://www.scopus.com/inward/record.url?scp=79951631209&partnerID=8YFLogxK
U2 - 10.1093/gerona/glq168
DO - 10.1093/gerona/glq168
M3 - Article
C2 - 20923909
AN - SCOPUS:79951631209
VL - 66 A
SP - 97
EP - 108
JO - Journals of Gerontology - Series A Biological Sciences and Medical Sciences
JF - Journals of Gerontology - Series A Biological Sciences and Medical Sciences
SN - 1079-5006
IS - 1
ER -