Plain English Summary
Background and study aims
A migraine is usually a moderate or severe headache felt as a throbbing pain on 1 side of the head. Many people also have symptoms such as feeling sick, being sick and increased sensitivity to light or sound. Migraine is a chronic neurological disorder with a high social impact. Several diets have been proposed to help managing migraine, with different outcomes. We aimed at evaluating the effect of education on the Healthy Eating Plate on migraine frequency and disability.
Who can participate?
Patients aged 18 years or above with diagnosis of migraine with aura or migraine without aura.
What does the study involve?
The study will involve clinical evaluation (questionnaire) of diet habit and migraine disability, and anthropometric measure, followed by education on healthy eating from a nutritional biologist. After three months, the evaluation will be repeated.
What are the possible benefits and risks of participating?
No risk are expected. The patients will be educated on healthy eating with possible general benefits (beyond migraine).
Where is the study run from?
Campus Bio Medico University Hospital, Italy.
When is the study starting and how long is it expected to run for?
March 2018 to September 2019.
Who is funding the study?
Università Campus Bio-Medico di Roma, Italy.
Who is the main contact?
Dr Claudia Altamura
c.altamura@unicampus.it
Trial website
Contact information
Type
Scientific
Primary contact
Dr Claudia Altamura
ORCID ID
http://orcid.org/0000-0002-5934-5535
Contact details
via Alvaro del Portillo
200
Roma
00122
Italy
+39 (0)622511220
c.altamura@unicampus.it
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
prot 6.18TS
Study information
Scientific title
The healthy eating plate advice for migraine prevention
Acronym
CEFOOD
Study hypothesis
Healthy Eating Plate (HEP) advice can be of help in the management of migraine also as a strategy in add-on to pharmaceutical therapy.
Ethics approval
Approved 08/03/2018, Campus Bio-Medico University Ethical Board (Comitato Etico Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 200, 00128 ROMA, Italy; +39 06.22541.8809; comitato.etico@unicampus.it), ref: prot 6.18TS ComET CBM
Study design
Unblinded longitudinal interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Migraine
Intervention
This longitudinal study consists of three visits: a screening visit (T-12), a baseline visit after 12 weeks (T0) and a follow-up visit (T12).
At T-12, the eligible people sign the informed consent and fill a Frequency Food Questionnaire (FFQ) to assess their dietary habits and migraine disability clinical scales concerning the previous three months. All people will receive prophylactic treatment indications as appropriate.
At T0, the eligible people undergo the assessments again (FFQ, migraine disability scales, BMI). They are all educated about the indications of the healthy heating plate by a nutritional biologist.
At the follow-up visit patients fill in a Frequency Food Questionnaire (FFQ) to assess their dietary habits and migraine disability clinical scales concerning the previous three months.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Monthly migraine days measured using patient self-report
2. Monthly drug intake measured using patient self-report
3. Migraine disability assessment score (MIDAS) measured at 12 weeks before the intervention, baseline, and 12 weeks after the start of the intervention
Secondary outcome measures
none
Overall trial start date
10/03/2018
Overall trial end date
30/09/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Diagnosis of migraine with aura or migraine without aura
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
95 participants
Participant exclusion criteria
1. BMI > 30
2. Cancer
3. Inflammatory bowel disease
4. Celiac disease
5. Type 1 diabetes
6. Chronic renal insufficiency
7. Other neurological disorders
Recruitment start date
15/03/2018
Recruitment end date
30/09/2019
Locations
Countries of recruitment
Italy
Trial participating centre
Università Campus Bio-Medico di Roma
Via Alvaro del Portillo, 200
Roma
00122
Italy
Sponsor information
Organisation
Campus Bio Medico University Hospital
Sponsor details
via Alvaro del Portillo
200
Roma
00122
Italy
+39 (0)6225411889
f.vernieri@unicampus.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Università Campus Bio-Medico di Roma
Alternative name(s)
Campus Bio-Medico University
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Italy
Results and Publications
Publication and dissemination plan
To publish in a journal dedicated to nutrition or headache.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
01/03/2020
Participant level data
Available on request
Basic results (scientific)
Publication list