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临床试验/NCT03244735
NCT03244735已完成不适用

Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache. A Prospective Case Series

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
Attack frequency

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Modified Atkins Diet (MAD)

Experimental

CCH patients that follows at least 3 months of MAD

干预措施: Atkins diet (Other)

结局指标

主要结局

Attack frequency

时间窗: 3 months

Reduction of at least 50% of number of attacks per month

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cherubino DI LORENZO

Research Fellow

University of Roma La Sapienza

研究点 (2)

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