Design and conduct of the CALERIE study: comprehensive assessment of the long-term effects of reducing intake of energy
James Rochon, Connie W Bales, Eric Ravussin, Leanne M Redman, John O Holloszy, Susan B Racette, Susan B Roberts, Sai Krupa Das, Sergei Romashkan, Katherine M Galan, Evan C Hadley, William E Kraus, CALERIE Study Group, Eric Ravussin, Catherine Champagne, Alok Gupta, Corby Martin, Leanne Redman, Steven Smith, Donald Williamson, Corby Martin, Michelle Begnaud, Barbara Cerniauskas, Allison Davis, Jeanne Gabrielle, Heather Walden, Natalie Currier, Mandy Shipp, Sarah Masters, Melody McNicoll, Shelly Prince, Courtney Brock, Renee Puyau, Conrad Earnest, Jennifer Rood, Tiffany Stewart, Lillian Levitan, Crystal Traylor, Susan Thomas, Valerie Toups, Karen Jones, Stephanie Tatum, Celeste Waguespack, Kimberly Crotwell, Lisa Dalfrey, Amy Braymer, Rhonda Hilliard, Onolee Thomas, Jennifer Arceneaux, Stacie LaPrarie, Allison Strate, Susan Mancuso, Christy Beard, Alicia Hymel, Desti Shepard, John Correa, Denise Jarreau, Brenda Dahmer, Grace Bella, Elizabeth Soroe, Bridget Conner, Paige McCown, Stephanie Anaya, Melissa Lupo, Susan B Roberts, Sai Krupa Das, Simin Meydani, Roger Fielding, Isaac Greenberg, Anastassios Pittas, Edward Saltzman, Tammy Scott, Cheryl Gilhooly, Kimberly Gerber, Isaac Greenberg, Anastassios Pittas, Edward Saltzman, Tammy Scott, Cheryl Gilhooly, Kimberly Gerber, Isaac Greenberg, Marjory Kaplan, Christy Karabetian, Russell Kennedy, Lisa Robinson, Verona Bembridge, Maria Berlis, Scarlett Buer, Robert Carabello, Cherie Campbell, Lauren Collins, Marybeth Doherty, Alicia Freed, Chervonte Hernandez, Gyna Jean-Baptiste, Mary Krasinski, Marie Lim-Lucas, Ekaterina Maslova, Barbara Maxwell, Jean McShea, Ann Muchowski, Margaret Mulkerrin, Kerry Murphy, Carol Nelsen, Megan O'Neill, Helen Rasmussen, Brenda Roche, Eneida Roman, Gregory Sproull, Marie St Victor, Susan Storer, Katherine Strissel, Stephanie Valliere, Margaret Vilme, Justin Wheeler, Jill Wiley, Fania Yangarber, John O Holloszy, Luigi Fontana, Sam Klein, Charles Lambert, B Selma Mohammed, Susan Racette, Dennis Villareal, Rick Stein, Karen Cotton, Margaret Hof, Cherie Massmann, Kathleen Obert, Marni Pearlman, Tina M Reising, Laura Weber, Mary Uhrich, Morgan Schram, Mel Meyer, Chelsea Carlen, Lisa Kee, Barbara Larson, Mary McFerson, Rebecca Sabatino, Bridgett Toennies, James Rochon, Connie W Bales, Carl F Pieper, William Kraus, Katherine M Galan, Richard Adrian, Eleanor Law Allen, William Blasko, Manjushri Bhapkar, Nikka Brown, Maria Butts, Elaina K Cossin, Jennifer Curry, Jamie Daniel, Kathleen S Diemer, Lee Greiner, Darryl Johnson, Cassandra Jones, Lauren Lindblad, Luanne McAdams, Marty Mansfield, Senthil Murugesan, Lucy Piner, Christopher Plummer, Mike Revoir, Pamela Smith, Monica Spaulding, James Topping, William W Wong, Lucinda L Clarke, Chun W Liu, J Kennard Fraley, Ann V Schwartz, John Shepherd, Lisa Palermo, Susan Ewing, Michaela Rahorst, Caroline Navy, Michael Lewis, Russell P Tracy, Rebekah Boyle, Elaine Cornell, Patrick Daunais, Dean Draayer, Melissa Floersch, Nicole Gagne, Florence Keating, Angela Patnoad, Marcia Schmidt, Marcia Gavin, Frida Wiener, Ashley Hughes, Laura Benken, Amy Otto, Jeffrey Halter, David M Buchner, Patricia Elmer, Mark Espeland, Steven B Heymsfield, Xavier Pi-Sunyer, Thomas Prohaska, Sue Shapses, John Speakman, Richard Weindruch, Evan C Hadley, Judy Hannah, Sergei Romashkan, Mary Evans, James Rochon, Connie W Bales, Eric Ravussin, Leanne M Redman, John O Holloszy, Susan B Racette, Susan B Roberts, Sai Krupa Das, Sergei Romashkan, Katherine M Galan, Evan C Hadley, William E Kraus, CALERIE Study Group, Eric Ravussin, Catherine Champagne, Alok Gupta, Corby Martin, Leanne Redman, Steven Smith, Donald Williamson, Corby Martin, Michelle Begnaud, Barbara Cerniauskas, Allison Davis, Jeanne Gabrielle, Heather Walden, Natalie Currier, Mandy Shipp, Sarah Masters, Melody McNicoll, Shelly Prince, Courtney Brock, Renee Puyau, Conrad Earnest, Jennifer Rood, Tiffany Stewart, Lillian Levitan, Crystal Traylor, Susan Thomas, Valerie Toups, Karen Jones, Stephanie Tatum, Celeste Waguespack, Kimberly Crotwell, Lisa Dalfrey, Amy Braymer, Rhonda Hilliard, Onolee Thomas, Jennifer Arceneaux, Stacie LaPrarie, Allison Strate, Susan Mancuso, Christy Beard, Alicia Hymel, Desti Shepard, John Correa, Denise Jarreau, Brenda Dahmer, Grace Bella, Elizabeth Soroe, Bridget Conner, Paige McCown, Stephanie Anaya, Melissa Lupo, Susan B Roberts, Sai Krupa Das, Simin Meydani, Roger Fielding, Isaac Greenberg, Anastassios Pittas, Edward Saltzman, Tammy Scott, Cheryl Gilhooly, Kimberly Gerber, Isaac Greenberg, Anastassios Pittas, Edward Saltzman, Tammy Scott, Cheryl Gilhooly, Kimberly Gerber, Isaac Greenberg, Marjory Kaplan, Christy Karabetian, Russell Kennedy, Lisa Robinson, Verona Bembridge, Maria Berlis, Scarlett Buer, Robert Carabello, Cherie Campbell, Lauren Collins, Marybeth Doherty, Alicia Freed, Chervonte Hernandez, Gyna Jean-Baptiste, Mary Krasinski, Marie Lim-Lucas, Ekaterina Maslova, Barbara Maxwell, Jean McShea, Ann Muchowski, Margaret Mulkerrin, Kerry Murphy, Carol Nelsen, Megan O'Neill, Helen Rasmussen, Brenda Roche, Eneida Roman, Gregory Sproull, Marie St Victor, Susan Storer, Katherine Strissel, Stephanie Valliere, Margaret Vilme, Justin Wheeler, Jill Wiley, Fania Yangarber, John O Holloszy, Luigi Fontana, Sam Klein, Charles Lambert, B Selma Mohammed, Susan Racette, Dennis Villareal, Rick Stein, Karen Cotton, Margaret Hof, Cherie Massmann, Kathleen Obert, Marni Pearlman, Tina M Reising, Laura Weber, Mary Uhrich, Morgan Schram, Mel Meyer, Chelsea Carlen, Lisa Kee, Barbara Larson, Mary McFerson, Rebecca Sabatino, Bridgett Toennies, James Rochon, Connie W Bales, Carl F Pieper, William Kraus, Katherine M Galan, Richard Adrian, Eleanor Law Allen, William Blasko, Manjushri Bhapkar, Nikka Brown, Maria Butts, Elaina K Cossin, Jennifer Curry, Jamie Daniel, Kathleen S Diemer, Lee Greiner, Darryl Johnson, Cassandra Jones, Lauren Lindblad, Luanne McAdams, Marty Mansfield, Senthil Murugesan, Lucy Piner, Christopher Plummer, Mike Revoir, Pamela Smith, Monica Spaulding, James Topping, William W Wong, Lucinda L Clarke, Chun W Liu, J Kennard Fraley, Ann V Schwartz, John Shepherd, Lisa Palermo, Susan Ewing, Michaela Rahorst, Caroline Navy, Michael Lewis, Russell P Tracy, Rebekah Boyle, Elaine Cornell, Patrick Daunais, Dean Draayer, Melissa Floersch, Nicole Gagne, Florence Keating, Angela Patnoad, Marcia Schmidt, Marcia Gavin, Frida Wiener, Ashley Hughes, Laura Benken, Amy Otto, Jeffrey Halter, David M Buchner, Patricia Elmer, Mark Espeland, Steven B Heymsfield, Xavier Pi-Sunyer, Thomas Prohaska, Sue Shapses, John Speakman, Richard Weindruch, Evan C Hadley, Judy Hannah, Sergei Romashkan, Mary Evans
Abstract
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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Source: PubMed