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Safety of two-year caloric restriction in non-obese healthy individuals.

Publication ,  Journal Article
Romashkan, SV; Das, SK; Villareal, DT; Ravussin, E; Redman, LM; Rochon, J; Bhapkar, M; Kraus, WE; CALERIE Study Group,
Published in: Oncotarget
April 12, 2016

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 RESULTS: Three participants were withdrawn from the CR intervention because of the safety concerns.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.

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Published In

Oncotarget

DOI

EISSN

1949-2553

Publication Date

April 12, 2016

Volume

7

Issue

15

Start / End Page

19124 / 19133

Location

United States

Related Subject Headings

  • Young Adult
  • Risk Factors
  • Risk Assessment
  • Monitoring, Physiologic
  • Middle Aged
  • Male
  • Humans
  • Female
  • Caloric Restriction
  • Bone Density
 

Citation

APA
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Romashkan, S. V., Das, S. K., Villareal, D. T., Ravussin, E., Redman, L. M., Rochon, J., … CALERIE Study Group, . (2016). Safety of two-year caloric restriction in non-obese healthy individuals. Oncotarget, 7(15), 19124–19133. https://doi.org/10.18632/oncotarget.8093
Romashkan, Sergei V., Sai Krupa Das, Dennis T. Villareal, Eric Ravussin, Leanne M. Redman, James Rochon, Manjushri Bhapkar, William E. Kraus, and William E. CALERIE Study Group. “Safety of two-year caloric restriction in non-obese healthy individuals.Oncotarget 7, no. 15 (April 12, 2016): 19124–33. https://doi.org/10.18632/oncotarget.8093.
Romashkan SV, Das SK, Villareal DT, Ravussin E, Redman LM, Rochon J, et al. Safety of two-year caloric restriction in non-obese healthy individuals. Oncotarget. 2016 Apr 12;7(15):19124–33.
Romashkan, Sergei V., et al. “Safety of two-year caloric restriction in non-obese healthy individuals.Oncotarget, vol. 7, no. 15, Apr. 2016, pp. 19124–33. Pubmed, doi:10.18632/oncotarget.8093.
Romashkan SV, Das SK, Villareal DT, Ravussin E, Redman LM, Rochon J, Bhapkar M, Kraus WE, CALERIE Study Group. Safety of two-year caloric restriction in non-obese healthy individuals. Oncotarget. 2016 Apr 12;7(15):19124–19133.

Published In

Oncotarget

DOI

EISSN

1949-2553

Publication Date

April 12, 2016

Volume

7

Issue

15

Start / End Page

19124 / 19133

Location

United States

Related Subject Headings

  • Young Adult
  • Risk Factors
  • Risk Assessment
  • Monitoring, Physiologic
  • Middle Aged
  • Male
  • Humans
  • Female
  • Caloric Restriction
  • Bone Density