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

• Published in: Nutrients Vol. 11; no. 8; p. 1742
• Main Authors: Di Lorenzo, Cherubino, Pinto, Alessandro, Ienca, Roberta, Coppola, Gianluca, Sirianni, Giulio, Di Lorenzo, Giorgio, Parisi, Vincenzo, Serrao, Mariano, Spagnoli, Alessandra, Vestri, Annarita, Schoenen, Jean, Donini, Lorenzo M, Pierelli, Francesco
• Format: Journal Article Web Resource
• Language: English
• Published: Switzerland MDPI AG 28.07.2019; MDPI
• Subjects: Adult; Analgesics - therapeutic use; Attacks frequency; Body Mass Index; Caloric Restriction; Carbohydrates; Cross-Over Studies; Diet; Diet, Ketogenic; Double-Blind Method; Double-blind studies; drugs; Female; Flow velocity; Food; Human health sciences; Humans; ketogenic diet; Ketone bodies; ketones; Ketosis; Low-calorie; Low-carbohydrate; Male; Metabolism; Middle Aged; Migraine; Migraine Disorders - diagnosis; Migraine Disorders - diet therapy; Migraine Disorders - physiopathology; Neurologie; Neurology; Neurosciences; Obesity; Oils & fats; overweight; Overweight - diagnosis; Overweight - diet therapy; Overweight - physiopathology; patients; Proteins; Public health; Rome; Sciences de la santé humaine; therapeutics; Time Factors; Treatment Outcome; very low calorie diet; Weight control; Weight Loss; Rome; Italy; low-carbohydrate; attacks frequency; ketosis; migraine; weight loss; low-calorie; ketone bodies
• ISSN: 2072-6643; 2072-6643
• DOI: 10.3390/nu11081742

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.