Evidence map›Paper›PMID 31357685›Full record

Trial reportNutrients2019

A Randomized Double-Blind, Cross-Over Trial of very Low-Calorie Diet in Overweight Migraine Patients: A Possible Role for Ketones?

Cherubino Di Lorenzo, Alessandro Pinto, Roberta Ienca, Gianluca Coppola, Giulio Sirianni, Giorgio Di Lorenzo, Vincenzo Parisi, Mariano Serrao, Alessandra Spagnoli, Annarita Vestri and 3 more

Open access · goldAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
6.7field-weighted citation impact, top 2% 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

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 90 citations in OpenAlex.

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  12. Hallmarks of primary headache: part 1 - migraine.The journal of headache and pain · 2024
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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

13 authors at 6 institutions in 2 countries.

Cherubino Di LorenzoIRCCS-Fondazione Don Carlo Gnocchi, 20121 Milan, Italy. cherub@inwind.it.ORCID 0000-0003-0845-5694
Alessandro PintoDepartment of Experimental Medicine, Sapienza University of Rome, 00161 Roma, Italy.ORCID 0000-0002-4864-2294
Roberta IencaDepartment of Experimental Medicine, Sapienza University of Rome, 00161 Roma, Italy.
Gianluca CoppolaDepartment of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo Pontino, 04100 Latina, Italy.ORCID 0000-0002-8510-6925
Giulio SirianniAssociazione Eupraxia, Dietary Section, 00171 Rome, Italy.
Giorgio Di LorenzoLaboratory of Psychophysiology and Cognitive Neuroscience, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.ORCID 0000-0002-0576-4064
Vincenzo ParisiIRCCS-Fondazione Bietti, 00198 Rome, Italy.
Mariano SerraoDepartment of Experimental Medicine, Sapienza University of Rome, 00161 Roma, Italy.
Alessandra SpagnoliDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, 00161 Rome, Italy.
Annarita VestriDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, 00161 Rome, Italy.ORCID 0000-0002-6139-7174
Jean SchoenenHeadache Research Unit, University Department of Neurology CHR, Citadelle Hospital, University of Liège, 4000 Liège, Belgium.
Lorenzo M DoniniDepartment of Experimental Medicine, Sapienza University of Rome, 00161 Roma, Italy.
Francesco PierelliDepartment of Experimental Medicine, Sapienza University of Rome, 00161 Roma, Italy.
Sapienza University of Rome · ITDon Carlo Gnocchi Foundation · ITFondazione G.B. Bietti · ITIstituto Neurologico Mediterraneo · ITUniversity of Liège · BEUniversity of Rome Tor Vergata · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort (

Indexed as

Caloric RestrictionDiet, KetogenicAdultAnalgesicsBody Mass IndexCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersOverweightRomeTime FactorsTreatment OutcomeAnalgesicsattacks frequencyketone bodiesketosislow-calorielow-carbohydratemigraineweight loss

Identifiers

PMID31357685
PMCPMC6722531
OpenAlexW2964654469

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.