Journal
JOURNALS OF GERONTOLOGY SERIES A-BIOLOGICAL SCIENCES AND MEDICAL SCIENCES
Volume 66, Issue 1, Pages 97-108Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/gerona/glq168
Keywords
Aging; Caloric restriction; Resting metabolic rate; Markers of inflammation; Randomized controlled trial
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Funding
- National Institute on Aging, National Institutes of Health [U01AG022132, U01AG020478, U01AG020487, U01AG020480]
- NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES [P30DK072476] Funding Source: NIH RePORTER
- NATIONAL INSTITUTE ON AGING [U01AG022132, U01AG020478, U01AG020480, U01AG020487] Funding Source: NIH RePORTER
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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/m(2)) 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.
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