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

Journal Article (Journal Article;Multicenter Study)

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 RESULTS: Three participants were withdrawn from the CR intervention because of the safety concerns.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

Full Text

Duke Authors

Cited Authors

  • Romashkan, SV; Das, SK; Villareal, DT; Ravussin, E; Redman, LM; Rochon, J; Bhapkar, M; Kraus, WE; CALERIE Study Group,

Published Date

  • April 12, 2016

Published In

Volume / Issue

  • 7 / 15

Start / End Page

  • 19124 - 19133

PubMed ID

  • 26992237

Pubmed Central ID

  • PMC4991370

Electronic International Standard Serial Number (EISSN)

  • 1949-2553

Digital Object Identifier (DOI)

  • 10.18632/oncotarget.8093


  • eng

Conference Location

  • United States