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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?

Author information

1
IRCCS-Fondazione Don Carlo Gnocchi, 20121 Milan, Italy. cherub@inwind.it.
2
Department of Experimental Medicine, Sapienza University of Rome, 00161 Roma, Italy.
3
Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo Pontino, 04100 Latina, Italy.
4
Associazione Eupraxia, Dietary Section, 00171 Rome, Italy.
5
Laboratory of Psychophysiology and Cognitive Neuroscience, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.
6
IRCCS Fondazione Santa Lucia, 00142 Rome, Italy.
7
IRCCS-Fondazione Bietti, 00198 Rome, Italy.
8
Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00161 Rome, Italy.
9
Headache Research Unit, University Department of Neurology CHR, Citadelle Hospital, University of Liège, 4000 Liège, Belgium.
10
IRCCS-Neuromed, 86077 Pozzilli (IS), Italy.

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 (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.

KEYWORDS:

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

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