Evidence map›Paper›PMID 26992237›Full record

Trial reportOncotarget2016

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

Sergei V Romashkan, Sai Krupa Das, Dennis T Villareal, Eric Ravussin, Leanne M Redman, James Rochon, Manjushri Bhapkar, William E Kraus, CALERIE Study Group

Open access · diamondAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Oncotarget, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
3.7field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 54 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Sergei V RomashkanNational Institute on Aging, Bethesda, MD, USA.
Sai Krupa DasJean Mayer US Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.
Dennis T VillarealWashington University School of Medicine, St Louis, MO, USA.
Eric RavussinPennington Biomedical Research Center, Baton Rouge, LA, USA.
Leanne M RedmanPennington Biomedical Research Center, Baton Rouge, LA, USA.
James RochonRho Federal Systems, Chapel Hill, NC, USA.
Manjushri BhapkarDuke Clinical Research Institute and Duke University School of Medicine, Durham, NC, USA.
William E KrausDuke Clinical Research Institute and Duke University School of Medicine, Durham, NC, USA.
CALERIE Study Group
Duke University · USPennington Biomedical Research Center · USTufts University · USNational Institute on Aging · US

Funding

Coordinating Center for CALERIEU01AG022132 · NIA · DUKE UNIVERSITY · PI KRAUS, WILLIAM E · 2002 to 2013
$24.9M
Metabolic Adaptations to Two Year Caloric RestrictionU01AG020478 · NIA · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI RAVUSSIN, ERIC · 2002 to 2008
$13.4M
Caloric Restriction and Aging in HumansU01AG020487 · NIA · WASHINGTON UNIVERSITY · PI HOLLOSZY, JOHN O. · 2001 to 2009
$8.9M
Dietary Energy Restriction and Metabolic Aging in HumansU01AG020480 · NIA · TUFTS UNIVERSITY BOSTON · PI ROBERTS, SUSAN B · 2002 to 2008
$8.2M
Biomarkers of Caloric Restriction in Humans: the CALERIE BiorepositoryU24AG047121 · NIA · DUKE UNIVERSITY · PI KRAUS, WILLIAM E, PIEPER, CARL F · 2015 to 2019
$3.2M
NIA NIH HHS U01 AG020478NIA NIH HHS U01 AG020480NIA NIH HHS U01 AG020487NIA NIH HHS U01 AG022132NIA NIH HHS U24 AG047121
6 · The paper itself

Abstract

backgroundThe extent to which sustained caloric restriction (CR) in healthy non-obese adults is safe has not been previously investigated.

objectiveAssess the safety and tolerability of sustained two-year CR intervention in healthy, non-obese adults.

designA 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.

resultsThree 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.

conclusionsTwo-years of CR at levels achieved in CALERIE was safe and well tolerated. Close monitoring for excessive bone loss and anemia is important.

Indexed as

Body CompositionBody WeightBone DensityAdultAnemiaCaloric RestrictionFemaleHumansMaleMiddle AgedMonitoring, PhysiologicRisk AssessmentRisk FactorsYoung Adultcalorie restrictiondietary energy restrictionGerotargethumanssafety

Identifiers

PMID26992237
PMCPMC4991370
OpenAlexW2305504094

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.