TY - JOUR
T1 - The CALERIE Study
T2 - Design and methods of an innovative 25% caloric restriction intervention
AU - Rickman, Amy D.
AU - Williamson, Donald A.
AU - Martin, Corby K.
AU - Gilhooly, Cheryl H.
AU - Stein, Richard I.
AU - Bales, Connie W.
AU - Roberts, Susan
AU - Das, Sai Krupa
N1 - Funding Information:
Funding support: This research was supported by grants 5U01AG022132-06 , 5U01AG020478-06 , 5U01AG020487-07 and 5U01AG020480-06 from the National Institute on Aging and K23 DK068052 (NIDDK ) of the U.S. National Institutes of Health .
PY - 2011/11
Y1 - 2011/11
N2 - Animal studies have shown that life span is extended by caloric restriction (CR). This manuscript describes the design and methodology of an innovative CR intervention, which is the treatment arm of the CALERIE Study. This study is a multi-center, randomized controlled trial examining the effects of 2years of CR on biomarkers of longevity among non-obese (BMI≥22kg/m 2 and <28kg/m 2) adults. CALERIE is the first investigation of the effects of long-term CR on the aging process in non-obese humans. 220 healthy volunteers across 3 sites were recruited beginning in May 2007. Participants were randomized in a 2:1 ratio between the CR or control group (i.e., ad libitum diet). An intensive intervention was designed to assist participants in adhering to the 25% CR prescription for a two-year duration. The intervention was designed to optimize the likelihood that 25% CR would be achieved through a variety of nutritional and behavioral strategies, several of which are innovative methods for achieving CR. The intervention includes the following components: an intensive, "mixed" format schedule of group/individual sessions, meal provision phase with exposure to various diets, Personal Digital Assistants to monitor caloric intake, unique portion estimation training, tailored treatment using a computer tracking system, toolbox strategies and algorithms, as well as comprehensive coverage of nutrition and behavioral topics in order to assist participants in meeting their CR goal. This manuscript provides an overview of the CR intensive intervention and may be of assistance for other researchers and clinicians in designing future trials.
AB - Animal studies have shown that life span is extended by caloric restriction (CR). This manuscript describes the design and methodology of an innovative CR intervention, which is the treatment arm of the CALERIE Study. This study is a multi-center, randomized controlled trial examining the effects of 2years of CR on biomarkers of longevity among non-obese (BMI≥22kg/m 2 and <28kg/m 2) adults. CALERIE is the first investigation of the effects of long-term CR on the aging process in non-obese humans. 220 healthy volunteers across 3 sites were recruited beginning in May 2007. Participants were randomized in a 2:1 ratio between the CR or control group (i.e., ad libitum diet). An intensive intervention was designed to assist participants in adhering to the 25% CR prescription for a two-year duration. The intervention was designed to optimize the likelihood that 25% CR would be achieved through a variety of nutritional and behavioral strategies, several of which are innovative methods for achieving CR. The intervention includes the following components: an intensive, "mixed" format schedule of group/individual sessions, meal provision phase with exposure to various diets, Personal Digital Assistants to monitor caloric intake, unique portion estimation training, tailored treatment using a computer tracking system, toolbox strategies and algorithms, as well as comprehensive coverage of nutrition and behavioral topics in order to assist participants in meeting their CR goal. This manuscript provides an overview of the CR intensive intervention and may be of assistance for other researchers and clinicians in designing future trials.
KW - Aging
KW - Caloric restriction
KW - Intervention
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=80053384386&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2011.07.002
DO - 10.1016/j.cct.2011.07.002
M3 - Article
C2 - 21767664
AN - SCOPUS:80053384386
SN - 1551-7144
VL - 32
SP - 874
EP - 881
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 6
ER -