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Table 1 Inclusion and exclusion criteria

From: Very-low-calorie ketogenic diet vs hypocaloric balanced diet in the prevention of high-frequency episodic migraine: the EMIKETO randomized, controlled trial

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