Healthy diet to prevent migraine
| ISRCTN | ISRCTN14092914 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14092914 |
| Secondary identifying numbers | prot 6.18TS |
- Submission date
- 26/01/2020
- Registration date
- 14/02/2020
- Last edited
- 03/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Scientific
via Alvaro del Portillo, 200
Roma
00122
Italy
 ORCID ID |
0000-0002-5934-5535 |
|---|---|
| Phone | +39 (0)622511220 |
| c.altamura@unicampus.it |
Study information
| Study design | Unblinded longitudinal interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | The healthy eating plate advice for migraine prevention |
| Study acronym | CEFOOD |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 | Behavioural |
| 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 study start date | 10/03/2018 |
| Completion date | 30/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 95 participants |
| Total final enrolment | 97 |
| Key inclusion criteria | Diagnosis of migraine with aura or migraine without aura |
| Key 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 |
| Date of first enrolment | 15/03/2018 |
| Date of final enrolment | 30/09/2019 |
Locations
Countries of recruitment
- Italy
Study participating centre
Roma
00122
Italy
Sponsor information
Hospital/treatment centre
via Alvaro del Portillo, 200
Roma
00122
Italy
| Phone | +39 (0)6225411889 |
|---|---|
| f.vernieri@unicampus.it | |
| Website | http://www.campusbiomedicohospital.com/ |
"ROR" |
https://ror.org/04gqbd180 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Campus Bio-Medico University
- Location
- Italy
Results and Publications
| Intention to publish date | 01/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | To publish in a journal dedicated to nutrition or headache. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/05/2020 | 03/09/2020 | Yes | No |
Editorial Notes
03/09/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
20/03/2020: Internal review.
28/01/2020: Trial’s existence confirmed by Campus Bio-Medico University Ethical Board
