Protocol summary
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Study aim
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The effect of inulin supplements on inflammatory status, oxidative stress, intestinal permeability, clinical symptoms and mood in women with migraine
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Design
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A randomized controlled clinical trial with parallel groups, double-blind, randomized
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Settings and conduct
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The present study is a double-blind, randomized, parallel clinical trial. The participants will be selected from women migraine patients who refer to the neurology clinic in Isfahan city. At the beginning and end of the study, venous blood samples, anthropometric measurements, questionnaires related to migraine, demographic information and socio-economic status of patients will be measured and recorded.
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Participants/Inclusion and exclusion criteria
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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: 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, pregnancy and lactation, taking nutritional supplements in the past 3 months, taking anticoagulants, smoking, and following a special diet.
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Intervention groups
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Intervention group (N=40): Inulin, with commercial name Frutafit® TEX, Sensus/Netherlands. The supplement will be given to patients in 10 grams packs for 12 weeks.
Control group: Maltodextrin powder, 10 grams per day.
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Main outcome variables
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Clinical symptoms of migraine, oxidative stress and inflammatory status, mental health and quality of life
General information
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Reason for update
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Exclusion criteria are very restricting, which may affect the credibility and universality of the study results
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121216011763N58
Registration date:
2023-04-23, 1402/02/03
Registration timing:
prospective
Last update:
2023-09-17, 1402/06/26
Update count:
2
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Registration date
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2023-04-23, 1402/02/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-05-06, 1402/02/16
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Expected recruitment end date
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2023-11-21, 1402/08/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of inulin supplementation on inflammatory status, oxidative stress, intestinal permeability, clinical features and mood in women with migraine
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Public title
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The effect of inulin supplement in migraine
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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:
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
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Age
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From 20 years old to 50 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-15, 1401/12/24
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1401.416
Health conditions studied
1
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Description of health condition studied
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Migraine
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ICD-10 code
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G43
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ICD-10 code description
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Migraine
Primary outcomes
1
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Description
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clinical symptoms of migraine (severity, frequency, duration of migraine attacks)
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Visual Analogue Scale (VAS) questionnaire and clinical examination
Secondary outcomes
1
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Description
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Depression, stress, anxiety
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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DASS-21questionnaire
2
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Description
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Quality of Life in Migraine Patients
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Migraine –Specific Quality of Life (MSQ) questionnaire
3
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Description
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Physical activity
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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International Physical Activity Questionnaire (IPAQ)
4
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Description
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Anthropometric indices
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Seca scale and portable stadiometer
5
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Description
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Serum levels of Zonulin
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA) kits
6
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Description
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serum levels of High sensitive C-reactive protein (Hs-CRP)
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA) kits
7
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Description
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Serum Nitric Oxide
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA) kits
8
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Description
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Total antioxidant capacity
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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biochemical kit of KiaZist Co.
9
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Description
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Total oxidant status
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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biochemical kit of KiaZist Co.
Intervention groups
1
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Description
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Intervention group: one pack of 10 grams of inulin daily for 12 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: one pack of 10 grams of maltodextrin daily for 12 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available