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Safety of two-year caloric restriction in non-obese healthy individuals
BACKGROUND: The extent to which sustained caloric restriction (CR) in healthy non-obese adults is safe has not been previously investigated. OBJECTIVE: Assess the safety and tolerability of sustained two-year CR intervention in healthy, non-obese adults. DESIGN: A multi-center, randomized controlled...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Impact Journals LLC
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4991370/ https://www.ncbi.nlm.nih.gov/pubmed/26992237 http://dx.doi.org/10.18632/oncotarget.8093 |
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author | Romashkan, Sergei V. Das, Sai Krupa Villareal, Dennis T. Ravussin, Eric Redman, Leanne M. Rochon, James Bhapkar, Manjushri Kraus, William E. |
author_facet | Romashkan, Sergei V. Das, Sai Krupa Villareal, Dennis T. Ravussin, Eric Redman, Leanne M. Rochon, James Bhapkar, Manjushri Kraus, William E. |
author_sort | Romashkan, Sergei V. |
collection | PubMed |
description | BACKGROUND: The extent to which sustained caloric restriction (CR) in healthy non-obese adults is safe has not been previously investigated. OBJECTIVE: Assess the safety and tolerability of sustained two-year CR intervention in healthy, non-obese adults. DESIGN: A multi-center, randomized controlled trial. Participants were randomized using a 2:1 allocation in favor of 25% CR vs. Ad-Libitum intake (AL). Adverse and serious adverse events (AE, SAE), safety laboratory tests, and other safety parameters were closely monitored. RESULTS: Three participants were withdrawn from the CR intervention because of the safety concerns. No deaths and one SAE was reported by participants in the CR group. Although the difference in AE between AL and CR groups was not significant, within the CR group, the incidence of nervous system (p = 0.02), musculoskeletal (p = 0.02) and reproductive system (p = 0.002) disorders was significantly higher in the normal-weight than in the overweight participants. At months 12 and 24, bone mineral densities at the lumbar spine, total hip, and femoral neck of participants in the CR group were significantly lower than in those in the AL group. CONCLUSIONS: Two-years of CR at levels achieved in CALERIE was safe and well tolerated. Close monitoring for excessive bone loss and anemia is important. |
format | Online Article Text |
id | pubmed-4991370 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Impact Journals LLC |
record_format | MEDLINE/PubMed |
spelling | pubmed-49913702016-09-01 Safety of two-year caloric restriction in non-obese healthy individuals Romashkan, Sergei V. Das, Sai Krupa Villareal, Dennis T. Ravussin, Eric Redman, Leanne M. Rochon, James Bhapkar, Manjushri Kraus, William E. Oncotarget Research Paper: Gerotarget (Focus on Aging) BACKGROUND: The extent to which sustained caloric restriction (CR) in healthy non-obese adults is safe has not been previously investigated. OBJECTIVE: Assess the safety and tolerability of sustained two-year CR intervention in healthy, non-obese adults. DESIGN: A multi-center, randomized controlled trial. Participants were randomized using a 2:1 allocation in favor of 25% CR vs. Ad-Libitum intake (AL). Adverse and serious adverse events (AE, SAE), safety laboratory tests, and other safety parameters were closely monitored. RESULTS: Three participants were withdrawn from the CR intervention because of the safety concerns. No deaths and one SAE was reported by participants in the CR group. Although the difference in AE between AL and CR groups was not significant, within the CR group, the incidence of nervous system (p = 0.02), musculoskeletal (p = 0.02) and reproductive system (p = 0.002) disorders was significantly higher in the normal-weight than in the overweight participants. At months 12 and 24, bone mineral densities at the lumbar spine, total hip, and femoral neck of participants in the CR group were significantly lower than in those in the AL group. CONCLUSIONS: Two-years of CR at levels achieved in CALERIE was safe and well tolerated. Close monitoring for excessive bone loss and anemia is important. Impact Journals LLC 2016-03-15 /pmc/articles/PMC4991370/ /pubmed/26992237 http://dx.doi.org/10.18632/oncotarget.8093 Text en Copyright: © 2016 Romashkan et al. http://creativecommons.org/licenses/by/2.5/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Paper: Gerotarget (Focus on Aging) Romashkan, Sergei V. Das, Sai Krupa Villareal, Dennis T. Ravussin, Eric Redman, Leanne M. Rochon, James Bhapkar, Manjushri Kraus, William E. Safety of two-year caloric restriction in non-obese healthy individuals |
title | Safety of two-year caloric restriction in non-obese healthy individuals |
title_full | Safety of two-year caloric restriction in non-obese healthy individuals |
title_fullStr | Safety of two-year caloric restriction in non-obese healthy individuals |
title_full_unstemmed | Safety of two-year caloric restriction in non-obese healthy individuals |
title_short | Safety of two-year caloric restriction in non-obese healthy individuals |
title_sort | safety of two-year caloric restriction in non-obese healthy individuals |
topic | Research Paper: Gerotarget (Focus on Aging) |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4991370/ https://www.ncbi.nlm.nih.gov/pubmed/26992237 http://dx.doi.org/10.18632/oncotarget.8093 |
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