Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: a Prospective Case Series
Condition: Chronic Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional

Summary: 
      Atkins diet is a nutritional regimen characterized by ad libitum protein and fat intake, but
      carbohydrate restriction. It is followed by millions of people around the word as a
      life-style, but in the last years was proposed as a treatment for the epilepsy, by its
      capacity to induce the state of ketosis.

      Since Authors observed that ketosis could be also useful in migraine, and migraine shares
      some pathophysiological features with cluster headache, The aim of the study is to test the
      efficacy of Atkins diet in Cluster Headache by an open label one harm observational study.
    

Detailed description: 
      The Atkins diet is a ketogenic high-fat, low-carbohydrate diet for long adopted as lifestyle
      by people that dislike have an high carbohydrate intake. This nutritional life style seems to
      account for more energy in the daily activity and an easy weight control. In the last years,
      researchers showed that a modified Atkins diet (MAD) can be useful to treat drug resistant
      epilepsy, maybe by the induction of ketogenesis.

      Ketogenesis, ketone-body formation, is a physiologic phenomenon also observed in patients
      following low-carbohydrate high fat diets. Different Authors evidenced a protective effect of
      ketone bodies also on migraine that shares some pathophysiological features with cluster
      headache (CH).

      CH is the worst form of headache, also called as "suicide headache"; in particular its
      unremitting form, called Chronic CH (CCH) is regarded as a clinical challenge for
      neurologist, if refractory to pharmacological treatments. So far, no data are available about
      a beneficial effect of ketogenesis in CH. However, the beta hydroxybutyrate (BHB) has a
      chemical formula similar to gamma hydroxybutyrate (GHB) that has shown to be effective in CH.
      Moreover, ketosis has also a beneficial effect on hypothalamic dysfunctions that are shared
      by some form of epilepsy and CH.

      Aim of this study is verify in an open label observational study if a MAD can be useful in
      the treatment of CCH. In case of positive outcome, the results could be used as preliminary
      data to design a double blind versus placebo study, to asses definitively if ketogenesis is
      really able to prevent/avoid headache attacks in CH.

      Methods: By the Italian branch of the Organization for the Understanding of Cluster Headache
      (OUCH), there will be recruited CCH volunteers that accept to modify their diet according to
      Atkins Diet for at least three months.

      Headache attack frequency will be collected on specific headache-calendars and a comparison
      between the pre-diet phase and the during-the-diet- phase will be performed.
    

Intervention name(s): Atkins diet
Intervention type(s): Other
Intervention description(s): A nutritional regimen characterized by high fat low carbohydrate intake.
Intervention model: Single Group Assignment
Intervention model description: Case series
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ketogenic Diet