Chronic Cluster HeadacheCCHDNCT03244735
Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: a Prospective Case Series
A study testing Atkins diet in people with Chronic Cluster Headache, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Cluster Headache
- What is being tested?
- Atkins diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache. A Prospective Case Series
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.
Read the 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.
- Conditions
- Chronic Cluster Headache
- Being tested
- Atkins diet
- Keywords
- Ketogenic Diet
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atkins dietOther
A nutritional regimen characterized by high fat low carbohydrate intake.
| Study group | Role | What they receive |
|---|---|---|
| Modified Atkins Diet (MAD) | Experimental | CCH patients that follows at least 3 months of MAD Receives: Other: Atkins diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attack frequency
Reduction of at least 50% of number of attacks per month
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study startJan 2017
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case series
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cherubino DI LORENZO, University of Roma La Sapienza
- Investigators
- Francesco Pierelli, MD, Study chair, Sapienza Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244735
- Sponsor's protocol ID
- CCHDiet
- Acronym
- CCHD
- Status last verified
- Aug 2017
- First submitted
- 5 Aug 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not share data
Publications
Di Lorenzo C, Coppola G, Sirianni G, Rossi P, Pierelli F. O045. Cluster headache improvement during Ketogenic Diet. J Headache Pain. 2015 Dec;16(Suppl 1):A99. doi: 10.1186/1129-2377-16-S1-A99. No abstract available.
PubMed 28132289Di Lorenzo C, Coppola G, Di Lenola D, Evangelista M, Sirianni G, Rossi P, Di Lorenzo G, Serrao M, Pierelli F. Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: An Open-Label, Single-Arm, Clinical Trial. Front Neurol. 2018 Feb 12;9:64. doi: 10.3389/fneur.2018.00064. eCollection 2018.
PubMed 29483892
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache. A Prospective Case Series
- ClinicalTrials.gov ID
- NCT03244735
- Acronym / sponsor ID
- CCHD / CCHDiet
- Conditions
- Chronic Cluster Headache
- Keywords
- Ketogenic Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case series
| Arm | Type | Receives |
|---|---|---|
| Modified Atkins Diet (MAD) | Experimental | Other: Atkins dietCCH patients that follows at least 3 months of MAD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atkins dietA nutritional regimen characterized by high fat low carbohydrate intake. | Other | Modified Atkins Diet (MAD) |
Primary outcome
Attack frequency
Time frame: 3 months
Reduction of at least 50% of number of attacks per month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Background: PubMed 28132289Di Lorenzo C, Coppola G, Sirianni G, Rossi P, Pierelli F. O045. Cluster headache improvement during Ketogenic Diet. J Headache Pain. 2015 Dec;16(Suppl 1):A99. doi: 10.1186/1129-2377-16-S1-A99. No abstract available.
- Derived from this study: PubMed 29483892Di Lorenzo C, Coppola G, Di Lenola D, Evangelista M, Sirianni G, Rossi P, Di Lorenzo G, Serrao M, Pierelli F. Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: An Open-Label, Single-Arm, Clinical Trial. Front Neurol. 2018 Feb 12;9:64. doi: 10.3389/fneur.2018.00064. eCollection 2018.
- Individual participant dataSharing planned: No. We do not share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Pierelli, MD study chair
Sapienza Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atkins diet in people with Chronic Cluster Headache, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attack frequency (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03244735, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.