Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: a Prospective Case Series (CCHD)
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|ClinicalTrials.gov Identifier: NCT03244735|
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : August 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Cluster Headache||Other: Atkins diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Case series|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache. A Prospective Case Series|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
Experimental: Modified Atkins Diet (MAD)
CCH patients that follows at least 3 months of MAD
Other: Atkins diet
A nutritional regimen characterized by high fat low carbohydrate intake.
- Attack frequency [ Time Frame: 3 months ]Reduction of at least 50% of number of attacks per month
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244735
|Policlinico Umberto I|
|Rome, Italy, 00161|
|Study Chair:||Francesco Pierelli, MD||Sapienza Univeristy|