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NCT03076060: Ketomig

Very Low Calories Ketogenic Diet in Migraine.

Completed NA Last updated 26 October 2017
What this trial tests

NA trial testing Ketogenic diet in Migraine in 35 participants. Completed in 23 October 2017.

Timeline
1 January 2017
Primary endpoint
1 September 2017
23 October 2017

Quick facts

Lead sponsorUniversity of Roma La Sapienza
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment35
Start date1 January 2017
Primary completion1 September 2017
Estimated completion23 October 2017
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Roma La Sapienza

Who can join

Adults 18 to 65, any sex, with Migraine or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ketogenesis is a physiologic phenomenon due to starvation or ketogenic diet (KD), a drastic restricted carbohydrate dietary regimen that induces lipid metabolism and ketone body (KB) synthesis. We followed, in a dietician clinical setting, a group of migraineurs who randomly received a one-month prescription of experimental diet, followed by a one-month of carbohydrate progressive reintroduction, then another one-month of experimental diet, followed by a one-month of carbohydrate progressive reintroduction. Experimental diets are a very-low calorie KD, or an isocaloric non-ketogenic diet. Aim of our study is verify if during ketogenesis migraine improves.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Randomized Double-Blind, Cross-Over Trial of very Low-Calorie Diet in Overweight Migraine Patients: A Possible Role for Ketones?
    Di Lorenzo C, Pinto A, Ienca R, Coppola G, et al · · 2019 · cited 58× · PMID 31357685 · DOI 10.3390/nu11081742

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Other trials of Ketogenic diet

Trials testing the same drug.

Other recruiting trials for Migraine

Currently open trials in the same condition.

Other University of Roma La Sapienza trials

Trials by the same sponsor.

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