Evidence map›Paper›PMID 35418509›Full record

Trial reportJournal of neurology, neurosurgery, and psychiatry2022

Phase II study of ketogenic diets in relapsing multiple sclerosis: safety, tolerability and potential clinical benefits.

J Nicholas Brenton, Diana Lehner-Gulotta, Emma Woolbright, Brenda Banwell, A G Christina Bergqvist, Shanshan Chen, Rachael Coleman, Mark Conaway, Myla D Goldman

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of neurology, neurosurgery, and psychiatry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 69 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 3 pooled it
9.6field-weighted citation impact, top 1% 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.

NCT03718247 completednot on this map

The Effect of the Ketogenic Diet on Patients With Relapsing Remitting Multiple Sclerosis

TypeobservationalSponsorUniversity of VirginiaRan2018 to 2021Enrolled45ConditionsRelapsing Remitting Multiple SclerosisArmsModified Atkins diet
NCT06510712 unknown statusnot on this mapstarted 2024, after this paper: background citation

Nutritional Risk and Health Research for Hospitalized Patients With Neurology Disorders in China

TypeobservationalSponsorXuanwu Hospital, BeijingRan2024 to 2026Enrolled10,000ConditionsNeurological Disorder
NCT06715436 narecruitingnot on this mapstarted 2024, after this paper: background citation

The Effects of Ketogenic Diet Therapy Versus the Mediterranean Diet on Quality of Life in a Group of Patients With Multiple Sclerosis - the KETOMED-MS Study

TypeinterventionalSponsorIRCCS National Neurological Institute "C. Mondino" FoundationRan2024 to 2025Enrolled111ConditionsMultiple Sclerosis, Relapsing-RemittingArmsMediterranean Diet, Ketogenic Diet, Control group
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 3 syntheses or guidelines pooled it, 91 citations in OpenAlex.

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  7. Association of serum homocysteine, folate, and vitamin BMultiple sclerosis and related disorders · 2023
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9 more citing papers are in PubMed but not listed here.

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 3 institutions in 1 country.

J Nicholas BrentonDepartment of Neurology, Division of Child Neurology, University of Virginia, Charlottesville, Virginia, USA jnb8h@virginia.edu.ORCID 0000-0001-9432-1347
Diana Lehner-GulottaDepartment of Neurology, Division of Child Neurology, University of Virginia, Charlottesville, Virginia, USA.
Emma WoolbrightDivision of Child Neurology, Children's Hospital of Philadelphia, Departments of Neurology and Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Brenda BanwellDepartment of Neurology, Universitygi of Virginia, Charlottesville, Virginia, USA.
A G Christina BergqvistDepartment of Neurology, Universitygi of Virginia, Charlottesville, Virginia, USA.
Shanshan ChenDepartment of Public Health Sciences, University of Virginia, Charlottesville, Virginia, USA.
Rachael ColemanDivision of Child Neurology, Children's Hospital of Philadelphia, Departments of Neurology and Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Mark ConawayDepartment of Biostatistics, Virginia Commonwealth University, Richmond, Virginia, USA.
Myla D GoldmanDepartment of Neurology, Virginia Commonwealth University, Richmond, Virginia, USA.
University of Virginia · USChildren's Hospital of Philadelphia · USVirginia Commonwealth University · US

Funding

The integrated Translational Health Research Institute of Virginia (iTHRIV): Using Data to Improve HealthUL1TR003015 · NCATS · UNIVERSITY OF VIRGINIA · PI BROWN, DONALD E, JOHNSTON, KAREN C. · 2019 to 2023
$20.3M
Institutional Career Development CoreKL2TR003016 · NCATS · UNIVERSITY OF VIRGINIA · PI PAPIN, JASON, WORRALL, BRADFORD B · 2019 to 2023
$3.9M
Interdisciplinary Training in Systems & Biomolecular Data ScienceT32GM145443 · NIGMS · UNIVERSITY OF VIRGINIA · PI Kevin A Janes, Jason Papin · 2022 to 2026
$1.5M
Obesity as a Driver of Inflammation and Brain Volume Loss in Pediatric Multiple SclerosisK23NS116225 · NINDS · UNIVERSITY OF VIRGINIA · PI BRENTON, JAMES NICHOLAS · 2021 to 2025
$962k
NCATS NIH HHS KL2 TR003016NCATS NIH HHS UL1 TR003015NIGMS NIH HHS T32 GM145443NINDS NIH HHS K23 NS116225
6 · The paper itself

Abstract

backgroundDietary changes impact human physiology and immune function and have potential as therapeutic strategies.

objectiveAssess the tolerability of a ketogenic diet (KD) in patients with relapsing multiple sclerosis (MS) and define the impact on laboratory and clinical outcome metrics.

methodsSixty-five subjects with relapsing MS enrolled into a 6-month prospective, intention-to-treat KD intervention. Adherence was monitored with daily urine ketone testing. At baseline, fatigue, depression and quality of life (QoL) scores were obtained in addition to fasting adipokines and MS-related clinical outcome metrics. Baseline metrics were repeated at 3 and/or 6 months on-diet.

resultsEighty-three percent of participants adhered to the KD for the study duration. Subjects exhibited significant reductions in fat mass and showed a nearly 50% decline in self-reported fatigue and depression scores. MS QoL physical health (67±16 vs 79±12, p<0.001) and mental health (71±17 vs 82±11, p<0.001) composite scores increased on-diet. Significant improvements were noted in Expanded Disability Status Scale scores (2.3±0.9 vs 1.9±1.1, p<0.001), 6-minute walk (1631±302 vs 1733±330 ft, p<0.001) and Nine-Hole Peg Test (21.5±3.6 vs 20.3±3.7 s, p<0.001). Serum leptin was lower (25.5±15.7 vs 14.0±11.7 ng/mL, p<0.001) and adiponectin was higher (11.4±7.8 vs 13.5±8.4 µg/mL, p=0.002) on the KD.

conclusionKDs are safe and tolerable over a 6-month study period and yield improvements in body composition, fatigue, depression, QoL, neurological disability and adipose-related inflammation in persons living with relapsing MS. TRIAL REGISTRATION INFORMATION: Registered on ClinicalTrials.gov under registration number NCT03718247, posted on 24 October 2018. First patient enrolment date: 1 November 2018. Link: https://clinicaltrials.gov/ct2/show/NCT03718247?term=NCT03718247&draw=2&rank=1.

Indexed as

Diet, KetogenicMultiple SclerosisMultiple Sclerosis, Relapsing-RemittingFatigueHumansProspective StudiesQuality of LifeMULTIPLE SCLEROSISNEUROIMMUNOLOGY

Identifiers

PMID35418509
PMCPMC9350909
OpenAlexW4223925664

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.