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

NCT03244735 | Completed

• 1 other identifier: CCHDiet
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cluster Headache

Keywords

Ketogenic Diet

Outcome Measures

Primary Outcomes (1)

• Attack frequency

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

  3 months

Study Arms (1)

Modified Atkins Diet (MAD)

EXPERIMENTAL

CCH patients that follows at least 3 months of MAD

Other: Atkins diet

Interventions

Atkins diet OTHER

A nutritional regimen characterized by high fat low carbohydrate intake.

Modified Atkins Diet (MAD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Umberto I

Rome, 00161, Italy

Location

Related Publications (2)

• 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.

  PMID: 28132289 BACKGROUND

• Di 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.

  PMID: 29483892 DERIVED

MeSH Terms

Conditions

Cluster Headache

Interventions

Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet, High-Protein; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Francesco Pierelli, MD

  Sapienza Univeristy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Model Details: Case series

Study Record Dates

• First Submitted: August 5, 2017
• First Posted: August 9, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)