Table 1.
Inclusion and exclusion criteria
| Inclusion criteria | Exclusion criteria |
|---|---|
| 27 kg/m2 < BMI < 35 kg/m2 | BMI < 27 or > 35 kg/m2 |
| Diagnosis of HFEM | Medication overuse, or any other primary or secondary headache [28] |
| Signing of the informed consent | Psychiatric disorders or any other condition or disease influencing treatment adherence |
| Migraine onset < 50 years | Type I diabetes mellitus or type II diabetes mellitus treated with insulin |
| Preventive migraine treatment discontinuation since at least 3 months (including RAAS inhibitors) | Use of antidepressants, anticonvulsants, lithium carbonate or neuroleptics for psychiatric comorbidities |
| Agreement to follow all study procedures, including follow-up visits | Use of potassium-sparing diuretics and RAAS inhibitors |
| Negative pregnancy test, performed on urine sample | Use of neurostimulators for migraine |
| Use of a valid contraceptive method throughout the study | Intake of supplements affecting weight |
| Agreement for all study participants not to divulgate study information | Intake of sugar-containing supplements |
| Pregnancy or breastfeeding | |
| Alcohol abuse | |
| Other neurological, cardiovascular, liver, respiratory, hematologic, autoimmune diseases issues that could, in the opinion of the investigator, influence the study results |