Evidence map›Paper›PMID 39137977›Full record

Trial reportJournal of neurology, neurosurgery, and psychiatry2025

Randomised controlled trial of intermittent calorie restriction in people with multiple sclerosis.

Laura Ghezzi, Valeria Tosti, Lisa Shi, Claudia Cantoni, Robert Mikesell, Samantha Lancia, Yanjiao Zhou, Kathleen Obert, Courtney Dula, Monokesh K Sen and 16 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurology, neurosurgery, and psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03539094 (Randomized Controlled Trial on Intermittent Fasting in Multiple Sclerosis), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03539094 nacompletednot on this map

Randomized Controlled Trial on Intermittent Fasting in Multiple Sclerosis

TypeinterventionalSponsorWashington University School of MedicineRan2018 to 2022Enrolled61ConditionsRelapsing Remitting Multiple SclerosisArmsIntermittent fasting
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Brain Nutrient Sensing: A Unifying Framework.Annual review of physiology · 2026
    Review
  7. Review
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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

26 authors.

Laura Ghezzi *Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milano, Italy.ORCID 0000-0001-8180-9730
Valeria Tosti *Department of Neurology, Washington University School of Medicine, St Louis, Missouri, USA.
Lisa ShiSchool of Medical Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0009-0007-9826-4424
Claudia CantoniDepartment of Translational Neuroscience, Barrow Neurological Institute, Phoenix, Arizona, USA.ORCID 0000-0003-1868-4511
Robert MikesellDepartment of Neurology, Washington University School of Medicine, St Louis, Missouri, USA.ORCID 0000-0002-1648-8288
Samantha LanciaDepartment of Neurology, Section on Statistical Planning and Analysis, UT Southwestern Medical Center, Dallas, Texas, USA.ORCID 0000-0001-8871-7134
Yanjiao ZhouUConn Health, Farmington, Connecticut, USA.ORCID 0000-0001-6528-7039
Kathleen ObertDepartment of Neurology, Washington University School of Medicine, St Louis, Missouri, USA.
Courtney DulaDepartment of Neurology, Washington University School of Medicine, St Louis, Missouri, USA.
Monokesh K SenSchool of Medical Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0003-3988-9196
Anjie GeSchool of Medical Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-1027-2793
Miguel TolentinoDepartment of Neurology, Washington University School of Medicine, St Louis, Missouri, USA.ORCID 0009-0003-2859-9086
Bryan BollmanDepartment of Neurology, Washington University School of Medicine, St Louis, Missouri, USA.ORCID 0000-0001-6757-041X
Anthony S DonSchool of Medical Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0003-1655-1184
Giuseppe MatareseDepartment of Molecular Medicine and Medical Biotechnologies, University of Naples Federico II, Napoli, Campania, Italy.ORCID 0000-0001-9429-0616
Alessandra ColamatteoDepartment of Molecular Medicine and Medical Biotechnologies, University of Naples Federico II, Napoli, Campania, Italy.ORCID 0000-0002-9693-3985
Claudia La RoccaConsiglio Nazionale delle Ricerche (IEOS-CNR), Istituto per l'endocrinologia e l'oncologia Gaetano Salvatore, Naples, Campania, Italy.ORCID 0000-0002-2003-887X
Maria Teresa LeporeConsiglio Nazionale delle Ricerche (IEOS-CNR), Istituto per l'endocrinologia e l'oncologia Gaetano Salvatore, Naples, Campania, Italy.ORCID 0000-0002-4701-6902
Cyrus A RajiDepartment of Neurology, Washington University School of Medicine, St Louis, Missouri, USA.
Farzaneh RahmaniWashington University School of Medicine, Mallinckrodt Institute of Radiology, Saint Louis, Missouri, USA.
Gregory F WuDepartment of Neurology, Washington University School of Medicine, St Louis, Missouri, USA.
Robert T NaismithDepartment of Neurology, Washington University School of Medicine, St Louis, Missouri, USA.ORCID 0000-0003-0520-4283
Luigi FontanaThe University of Sydney, Charles Perkins Centre, Sydney, New South Wales, Australia.ORCID 0000-0001-8500-5537
Anne H CrossDepartment of Neurology, Washington University School of Medicine, St Louis, Missouri, USA.ORCID 0000-0003-0829-7569
Amber Salter *Department of Neurology, Section on Statistical Planning and Analysis, UT Southwestern Medical Center, Dallas, Texas, USA.ORCID 0000-0002-1088-110X
Laura Piccio *Department of Neurology, Washington University School of Medicine, St Louis, Missouri, USA laura.piccio@sydney.edu.au.ORCID 0000-0002-8760-109X

Funding

Smartphone-Based "Burst" Cognitive AssessmentsP01AG003991 · NIA · WASHINGTON UNIVERSITY · PI JOHN MORRIS · 1985 to 2026
$69.5M
The natural history of AB accumulation in preclinical ADP01AG026276 · NIA · WASHINGTON UNIVERSITY · PI MORRIS, JOHN · 2005 to 2025
$49.5M
The Neighborhoods Study: Contextual Disadvantage and Alzheimer’s Disease and Related Dementias (ADRD)R01AG070883 · NIA · UNIVERSITY OF WISCONSIN-MADISON · PI AMY J. KIND · 2021 to 2026
$42.1M
Washington University Nutrition Obesity Research CenterP30DK056341 · NIDDK · WASHINGTON UNIVERSITY · PI Dominic N Reeds · 1999 to 2026
$30.2M
Longitudinal validation of retinal biomarkers against cerebral imaging in preclinical Alzheimer's diseaseR01AG079241 · NIA · UNIVERSITY OF RHODE ISLAND · PI Jessica Alber · 2022 to 2026
$10.4M
Neuroinflammation and Alzheimer's Disease Imaging Biomarkers in Midlife ObesityRF1AG072637 · NIA · WASHINGTON UNIVERSITY · PI RAJI, CYRUS A · 2021 to 2021
$2.3M
NIA NIH HHS P01 AG003991NIA NIH HHS P01 AG026276NIA NIH HHS R01 AG070883NIA NIH HHS R01 AG079241NIA NIH HHS RF1 AG072637NIDDK NIH HHS P30 DK056341
6 · The paper itself

Abstract

backgroundCalorie restriction (CR) ameliorates preclinical models of multiple sclerosis (MS) via multiple mechanisms. These include decreased leptin, a proinflammatory adipokine, but mechanistic studies in humans are lacking. Tests of daily and intermittent CR (iCR) in people with MS (pwMS) showed improvements in fatigue and well-being measures. This trial studied the effects of 12-week iCR on metabolic, immunological, and clinical outcomes in pwMS.

methodRelapsing-remitting MS participants were randomised to iCR or a control group. Study visits were conducted at baseline, 6 and 12 weeks. The primary outcome was reduction in serum leptin levels at 12 weeks. Feasibility and safety were assessed by diet adherence and adverse events (AEs). Secondary outcomes included changes in anthropometric and body composition measures, metabolic and immunologic profiling, and clinical measures. Mixed effects linear regression models were used to evaluate outcome differences between and within groups over time.

resultsForty-two pwMS were randomised, 34 completed the study (17/group). Leptin serum levels at 12 weeks were significantly lower in the iCR versus the control group (mean decrease -6.98 µg/dL, 95% CI: -28.02 to 14.06; p=0.03). Adherence to iCR was 99.5% and 97.2% at 6 and 12 weeks, respectively, and no serious AEs were reported. An increase in blood CD45RO

conclusionsiCR has the potential to benefit metabolic and immunologic profiles and is safe and feasible in pwMS. TRIAL REGISTRATION NUMBER: NCT03539094 .

Indexed as

Caloric RestrictionMultiple Sclerosis, Relapsing-RemittingAdultBody CompositionFemaleHumansLeptinMaleMiddle AgedTreatment OutcomeLeptinMULTIPLE SCLEROSISNEUROIMMUNOLOGY

Identifiers

PMID39137977
PMCPMC11877063

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.