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Nutrients. 2019 Jul 28;11(8). pii: E1742. doi: 10.3390/nu11081742.

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

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IRCCS-Fondazione Don Carlo Gnocchi, 20121 Milan, Italy.
Department of Experimental Medicine, Sapienza University of Rome, 00161 Roma, Italy.
Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo Pontino, 04100 Latina, Italy.
Associazione Eupraxia, Dietary Section, 00171 Rome, Italy.
Laboratory of Psychophysiology and Cognitive Neuroscience, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.
IRCCS Fondazione Santa Lucia, 00142 Rome, Italy.
IRCCS-Fondazione Bietti, 00198 Rome, Italy.
Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00161 Rome, Italy.
Headache Research Unit, University Department of Neurology CHR, Citadelle Hospital, University of Liège, 4000 Liège, Belgium.
IRCCS-Neuromed, 86077 Pozzilli (IS), Italy.


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 (n = 35) will be presented. Patients who dropped out (n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced -3.73 (95% CI: -5.31, -2.15) migraine days respect to VLCnKD (p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by -3.02 (95% CI: -4.15, -1.88) during VLCKD respect to VLCnKD (p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption (p = 0.112) and BMI (p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.


attacks frequency; ketone bodies; ketosis; low-calorie; low-carbohydrate; migraine; weight loss

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