biostudies-literatureUnknown20(1)Gross EFreie Akademische Gesellschaft BaselUniversity of BaselSwiss Headache SocietySwiss National Science FoundationUniversity of Basel Children&apos;s HospitalUniversity of Basel Hospital<h4>Background</h4>Currently available prophylactic migraine treatment options are limited and are associated with many, often intolerable, side-effects. Various lines of research suggest that abnormalities in energy metabolism are likely to be part of migraine pathophysiology. Previously, a ketogenic diet (KD) has been reported to lead to a drastic reduction in migraine frequency. An alternative method to a strict KD is inducing a mild nutritional ketosis (0.4-2 mmol/l) with exogenous ketogenic substances. The aim of this randomised, placebo-controlled, double-blind, crossover, single-centre trial is to demonstrate safety and superiority of beta-hydroxybutyrate (βHB) in mineral salt form over placebo in migraine prevention.<h4>Methods/design</h4>Forty-five episodic migraineurs (5-14 migraTrials61https://www.ebi.ac.uk/biostudies/studies/S-EPMC6337840biostudies-literatureEfficacy and safety of exogenous ketone bodies for preventive treatment of migraine: A study protocol for a single-centred, randomised, placebo-controlled, double-blind crossover trial.PMC6337840Fischer DPutananickal NSchmidt SCichon SVogt DROrsini ALGross ESandor PfalseEfficacy and safety of exogenous ketone bodies for preventive treatment of migraine: A study protocol for a single-centred, randomised, placebo-controlled, double-blind crossover trial.<h4>Background</h4>Currently available prophylactic migraine treatment options are limited and are associated with many, often intolerable, side-effects. Various lines of research suggest that abnormalities in energy metabolism are likely to be part of migraine pathophysiology. Previously, a ketogenic diet (KD) has been reported to lead to a drastic reduction in migraine frequency. An alternative method to a strict KD is inducing a mild nutritional ketosis (0.4-2 mmol/l) with exogenous ketogenic substances. The aim of this randomised, placebo-controlled, double-blind, crossover, single-centre trial is to demonstrate safety and superiority of beta-hydroxybutyrate (βHB) in mineral salt form over placebo in migraine prevention.<h4>Methods/design</h4>Forty-five episodic migraineurs (5-14 migra2019-01-01T00:00:00Z2019 Jan2026-05-05T06:38:17.284Z2019-03-26T22:39:02ZS-EPMC63378403065483510.1186/s13063-018-3120-7