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

• Main Authors: Cherubino Di Lorenzo, Alessandro Pinto, Roberta Ienca, Gianluca Coppola, Giulio Sirianni, Giorgio Di Lorenzo, Vincenzo Parisi, Mariano Serrao, Alessandra Spagnoli, Annarita Vestri, Jean Schoenen, Lorenzo M Donini, Francesco Pierelli
• Format: Article
• Language: English
• Published: MDPI AG 2019-07-01
• Series: Nutrients
• Subjects: ketosis; attacks frequency; migraine; ketone bodies; weight loss; low-carbohydrate; low-calorie
• Online Access: https://www.mdpi.com/2072-6643/11/8/1742

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 (<i>n</i> = 35) will be presented. Patients who dropped out (<i>n</i> = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced &#8722;3.73 (95% CI: &#8722;5.31, &#8722;2.15) migraine days respect to VLCnKD (<i>p</i> &lt; 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 &#8722;3.02 (95% CI: &#8722;4.15, &#8722;1.88) during VLCKD respect to VLCnKD (<i>p</i> &lt; 0.00001). There were no differences in the change of acute anti-migraine drug consumption (<i>p</i> = 0.112) and BMI (<i>p</i> = 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.