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IRCT20121216011763N58 IRCT 2023-04-23 Esfahan University of Medical Sciences The effect of inulin supplement in migraine The effect of inulin supplementation on inflammatory status, oxidative stress, intestinal permeability, clinical features and mood in women with migraine 2023-05-06 anticipated 80 Complete https://irct.ir/trial/69603 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will conduct based on https://www.sealedenvelope.com/simple-randomiser/v1/lists. Each block have capacity for 4 subjects. Then, within each block, subjects will be randomly assigned to treatment or placebo. Random assignment will be done using a random chain will be extracted from the site, Blinding description: This study is a double blind clinical trial (participant, researcher). Inulin supplement and placebo (identical from color, shape and odor) will be packaged in similar boxes and the researcher and patients will not be informed of the contents of the packs until the end of the study. 3 Migraine. 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.

public Dr. Gholamreza Askari

Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan

Isfahan Iran (Islamic Republic of) 8174673461 +98 913 266 3418 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Gholamreza Askari

Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan

Isfehan Iran (Islamic Republic of) 8174673461 +98 913 266 3418 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 50 years Female 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 G43 Migraine Treatment - Drugs Placebo Intervention group: one pack of 10 grams of inulin daily for 12 weeks Control group: one pack of 10 grams of maltodextrin daily for 12 weeks 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. 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. Esfahan University of Medical Sciences Approved 2023-03-15 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)