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Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: a Prospective Case Series (CCHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03244735
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : August 14, 2017
Information provided by (Responsible Party):
Cherubino DI LORENZO, University of Roma La Sapienza

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Cluster Headache Other: Atkins diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Case series
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Attack frequency [ Time Frame: 3 months ]
    Reduction of at least 50% of number of attacks per month

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diagnosis of CCH (less than 30 consecutive days of attacks remission in the last year)
  • kept a headache diary for at least 1 month
  • CH onset before the age of 50

Exclusion Criteria:

  • over consumption of acute pain-killers (triptan, analgesic, or ergotamine)
  • pregnancy or lactation
  • type I diabetes
  • serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03244735

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Policlinico Umberto I
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
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Study Chair: Francesco Pierelli, MD Sapienza Univeristy

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cherubino DI LORENZO, Research Fellow, University of Roma La Sapienza Identifier: NCT03244735    
Other Study ID Numbers: CCHDiet
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cherubino DI LORENZO, University of Roma La Sapienza:
Ketogenic Diet
Additional relevant MeSH terms:
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Cluster Headache
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases