Migraine. Migraine
Conditions
Interventions
Intervention 1: Intervention group: one pack of 10 grams of inulin daily for 12 weeks. Intervention 2: Control group: one pack of 10 grams of maltodextrin daily for 12 weeks.
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Patients who agree to participate in the study Diagnosis of migraine by a neurologist according to ICHD-3 Aged between 20 to 50 years old
Exclusion criteria
Exclusion criteria: Non-compliance with dietary recommendations and supplements(Use less than 80% of the prescribed supplement) Reaction and sensitivity to the prescribed supplement Lack of referral in different stages of study Suffering from tension headaches Suffering from gastrointestinal disorder like crohn’s and ulcerative colitis and other neurological disorders Pregnancy and lactation Taking nutritional supplements (including probiotics, prebiotics in the last 3 months) Following a special diet Antibiotics and anti-acids drugs in three months past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical symptoms of migraine (severity, frequency, duration of migraine attacks). Timepoint: At baseline and after 12 weeks. Method of measurement: Visual Analogue Scale (VAS) questionnaire and clinical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression, stress, anxiety. Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21questionnaire.;Quality of Life in Migraine Patients. Timepoint: At baseline and after 12 weeks. Method of measurement: Migraine –Specific Quality of Life (MSQ) questionnaire.;Physical activity. Timepoint: At baseline and after 12 weeks. Method of measurement: International Physical Activity Questionnaire (IPAQ).;Anthropometric indices. Timepoint: At baseline and after 12 weeks. Method of measurement: Seca scale and portable stadiometer.;Serum levels of Zonulin. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;Serum levels of High sensitive C-reactive protein (Hs-CRP). Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;Serum Nitric Oxide. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.;Total oxidant status. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Gholamreza Askari
Esfahan University of Medical Sciences
Outcome results
None listed