Evidence map›Paper›PMID 28734043›Full record

Trial reportJournal of the American Geriatrics Society2017

ENabling Reduction of Low-grade Inflammation in SEniors Pilot Study: Concept, Rationale, and Design.

Todd M Manini, Stephen D Anton, Daniel P Beavers, Jane A Cauley, Mark A Espeland, Roger A Fielding, Stephen B Kritchevsky, Christiaan Leeuwenburgh, Kristina H Lewis, Christine Liu and 12 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Geriatrics Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02676466 (The ENRGISE), which is not on this map. Cited by 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
3.0field-weighted citation impact, top 9% 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.

NCT02676466 phase2completednot on this map

The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study

TypeinterventionalSponsorUniversity of FloridaRan2016 to 2018Enrolled289ConditionsInflammationArmsOmega-3 fish oil, Losartan, Corn Oil (Fish oil Placebo), Cellulose Based (Losartan Placebo)
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Effect of Losartan and Fish Oil on Plasma IL-6 and Mobility in Older Persons. The ENRGISE Pilot Randomized Clinical Trial.The journals of gerontology. Series A, Biological sciences and medical sciences · 2019
    Trial
  6. The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.The journals of gerontology. Series A, Biological sciences and medical sciences · 2019
    Trial
  7. Article
  8. Article
  9. Article
  10. The Health, Aging, and Body Composition (Health ABC) Study-Ground-Breaking Science for 25 Years and Counting.The journals of gerontology. Series A, Biological sciences and medical sciences · 2023
    Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Nutrition and Frailty.The journal of nutrition, health & aging · 2018
    Article
  18. Article
  19. Article
  20. Review
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

22 authors at 8 institutions in 1 country.

Todd M ManiniDepartment of Aging and Geriatric Research, University of Florida, Gainesville, Florida.
Stephen D AntonDepartment of Aging and Geriatric Research, University of Florida, Gainesville, Florida.
Daniel P BeaversDepartment of Biostatistical Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.
Jane A CauleyDepartment of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Mark A EspelandDepartment of Biostatistical Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.
Roger A FieldingFriedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts.
Stephen B KritchevskyDepartment of Biostatistical Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.
Christiaan LeeuwenburghDepartment of Aging and Geriatric Research, University of Florida, Gainesville, Florida.
Kristina H LewisDepartment of Biostatistical Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.
Christine LiuFriedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts.
Mary M McDermottDivision of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Michael E MillerDepartment of Biostatistical Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.
Russell P TracyDepartment of Pathology & Laboratory Medicine, Larner College of Medicine, University of Vermont, Burlington, Vermont.
Jeremy D WalstonDivision of Geriatric Medicine and Gerontology, Johns Hopkins University, Baltimore, Maryland.
Barbara RadziszewskaDivision of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, Maryland.
Jane LuDepartment of Aging and Geriatric Research, University of Florida, Gainesville, Florida.
Cindy StoweDepartment of Biostatistical Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.
Samuel WuDepartment of Aging and Geriatric Research, University of Florida, Gainesville, Florida.
Anne B NewmanDepartment of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Walter T AmbrosiusDepartment of Biostatistical Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.
Marco PahorDepartment of Aging and Geriatric Research, University of Florida, Gainesville, Florida.
ENRGISE Pilot study investigators
Wake Forest University · USUniversity of Florida · USTufts University · USUniversity of Pittsburgh · USJohns Hopkins University · USNational Institute on Aging · USNorthwestern University · USUniversity of Vermont · US

Funding

Wake Forest Claude D. Pepper OAIC - RenewalP30AG021332 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Denise Kathryn Houston · 2002 to 2026
$36.4M
VARIABILITY, STABILITY & SMOOTHNESS OF WALKINGP30AG024827 · NIA · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Caterina Rosano · 2004 to 2026
$28.6M
TUFTS--FIELDINGP30AG031679 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI SHALENDER BHASIN · 2008 to 2026
$23.9M
University of Florida Older Americans Independence Center (OAIC)P30AG028740 · NIA · UNIVERSITY OF FLORIDA · PI Peihua Qiu · 2007 to 2026
$22.8M
The ENRGISE StudyU01AG050499 · NIA · UNIVERSITY OF FLORIDA · PI AMBROSIUS, WALTER T, PAHOR, MARCO · 2015 to 2017
$5.5M
Metabolic Costs of Daily Activities in Older AdultsR01AG042525 · NIA · UNIVERSITY OF FLORIDA · PI MANINI, TODD · 2013 to 2017
$1.6M
MtDNA variant modifiers of cardiopulmonary responsiveness to physical activityR01HL121023 · NHLBI · UNIVERSITY OF FLORIDA · PI FRAGOSO, CARLOS A. VAZ, MANINI, TODD · 2014 to 2017
$1.3M
NHLBI NIH HHS R01 HL121023NIA NIH HHS P30 AG021332NIA NIH HHS P30 AG024827NIA NIH HHS P30 AG028740NIA NIH HHS P30 AG031679NIA NIH HHS R01 AG042525NIA NIH HHS U01 AG050499
6 · The paper itself

Abstract

objectivesTo test two interventions to reduce interleukin (IL)-6 levels, an indicator of low-grade chronic inflammation and an independent risk factor for impaired mobility and slow walking speed in older adults.

designThe ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) Pilot Study was a multicenter, double-blind, placebo-controlled randomized pilot trial of two interventions to reduce IL-6 levels.

settingFive university-based research centers.

participantsTarget enrollment was 300 men and women aged 70 and older with an average plasma IL-6 level between 2.5 and 30 pg/mL measured twice at least 1 week apart. Participants had low to moderate physical function, defined as self-reported difficulty walking one-quarter of a mile or climbing a flight of stairs and usual walk speed of less than 1 m/s on a 4-m usual-pace walk.

interventionParticipants were randomized to losartan, omega-3 fish oil (ω-3), combined losartan and ω-3, or placebo. Randomization was stratified depending on eligibility for each group. A titration schedule was implemented to reach a dose that was safe and effective for IL-6 reduction. Maximal doses were 100 mg/d for losartan and 2.8 g/d for ω-3. MEASUREMENTS: IL-6, walking speed over 400 m, physical function (Short Physical Performance Battery), other inflammatory markers, safety, tolerability, frailty domains, and maximal leg strength were measured.

resultsResults from the ENRGISE Pilot Study will provide recruitment yields, feasibility, medication tolerance and adherence, and preliminary data to help justify a sample size for a more definitive randomized trial.

conclusionThe ENRGISE Pilot Study will inform a larger subsequent trial that is expected to have important clinical and public health implications for the growing population of older adults with low-grade chronic inflammation and mobility limitations.

Indexed as

Interleukin-6Mobility LimitationAgedAntihypertensive AgentsDouble-Blind MethodEicosapentaenoic AcidFemaleHumansInflammationLosartanMalePilot ProjectsAntihypertensive AgentsEicosapentaenoic AcidInterleukin-6Losartanchronic inflammationimmune systemmobility disabilityphysical function

Identifiers

PMID28734043
PMCPMC5642998
OpenAlexW2736750924

What OpenQuestion holds

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Registered trials

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.