The effect of inulin supplementation on inflammatory status, oxidative stress, intestinal permeability, clinical features and mood in women with migraine
The effect of inulin supplements on inflammatory status, oxidative stress, intestinal permeability, clinical symptoms and mood in women with migraine
Design
A randomized controlled clinical trial with parallel groups, double-blind, randomized
Settings and conduct
The present study is a double-blind, randomized, parallel clinical trial. The participants will be selected from women migraine patients who refer to the neurologist's office 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.
Participants/Inclusion and exclusion 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: 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.
Intervention groups
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.
Main outcome variables
Clinical symptoms of migraine, oxidative stress and inflammatory status, mental health and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N58
Registration date:2023-04-23, 1402/02/03
Registration timing:prospective
Last update:2023-04-23, 1402/02/03
Update count:2
Registration date
2023-04-23, 1402/02/03
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-06, 1402/02/16
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inulin supplementation on inflammatory status, oxidative stress, intestinal permeability, clinical features and mood in women with migraine
Public title
The effect of inulin supplement in migraine
Purpose
Treatment
Inclusion/Exclusion 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:
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 cardiovascular diseases, hypertension, diabetes, liver and kidney diseases, malignancies and other neurological disorders
Pregnancy and lactation
Taking nutritional supplements (including riboflavin, feverfew, magnesium and coenzyme Q10 in the last 3 months)
Following a special diet
Smoking
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.416
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
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
2
Description
Serum levels of Zonulin
Timepoint
At baseline and after 12 weeks
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits
3
Description
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
4
Description
Depression, stress, anxiety
Timepoint
At baseline and after 12 weeks
Method of measurement
DASS-21questionnaire
5
Description
Quality of Life in Migraine Patients
Timepoint
At baseline and after 12 weeks
Method of measurement
Migraine –Specific Quality of Life(MSQ)questionnaire
6
Description
Serum Nitric Oxide
Timepoint
At baseline and after 12 weeks
Method of measurement
biochemical kit of KiaZist Co.
7
Description
Total antioxidant capacity
Timepoint
At baseline and after 12 weeks
Method of measurement
biochemical kit of KiaZist Co.
8
Description
Total oxidant status
Timepoint
At baseline and after 12 weeks
Method of measurement
biochemical kit of KiaZist Co.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one pack of 10 grams of inulin daily for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: one pack of 10 grams of maltodextrin daily for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurologist's office located in Isfahan Khurshid Clinic
Full name of responsible person
Dr. Gholamreza Askari
Street address
khorshid medical educational research complex, Ostandari Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8145833117
Phone
+98 31 3222 2127
Email
Askari@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 266 3418
Email
askari@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 266 3418
Email
askari@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available