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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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History
# Registration date Revision Id
3 2023-09-17, 1402/06/26 279055
2 2023-06-26, 1402/04/05 270400
1 2023-04-23, 1402/02/03 262415
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  • Protocol summary

    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 of Al-Zahra Hospital 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.
    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.
    مطالعه حاضر یک کارآزمایی بالینی موازی تصادفی شده دو سو کور است. افراد شرکت کننده از بین خانم‌های مبتلا به میگرن مراجعه‌کننده به کلینیک مغز و اعصاب بیمارستان الزهرا در شهر اصفهان انتخاب خواهند شد. از تمامی بیماران خواسته می‌شود که در هر مراجعه پک استفاده نشده را بازگردانند. در ابتدا و انتهای مطالعه نمونه خون وریدی، اندازه گیری‌های تن سنجی، پرسشنامه‌های مربوط به میگرن، اطلاعات دموگرافیک و وضعیت اجتماعی- اقتصادی در بیماران اندازه گیری و ثبت خواهد شد.
    مطالعه حاضر یک کارآزمایی بالینی موازی تصادفی شده دو سو کور است. افراد شرکت کننده از بین خانم‌های مبتلا به میگرن مراجعه‌کننده به کلینیک مغز و اعصاب در شهر اصفهان انتخاب خواهند شد. از تمامی بیماران خواسته می‌شود که در هر مراجعه پک استفاده نشده را بازگردانند. در ابتدا و انتهای مطالعه نمونه خون وریدی، اندازه گیری‌های تن سنجی، پرسشنامه‌های مربوط به میگرن، اطلاعات دموگرافیک و وضعیت اجتماعی- اقتصادی در بیماران اندازه گیری و ثبت خواهد شد.

  • General information

    empty
    Exclusion criteria are very restricting, which may affect the credibility and universality of the study results
    empty
    به روز رسانی در معیار های عدم ورد به مطالعه انجام شد. زیرا بسیار محدود کننده بودند که ممکن است بر اعتبار و جهانی بودن نتایج مطالعه تأثیر بگذارد.
    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
    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
    عدم تبعیت از توصیه ها و مکمل غذایی ( مصرف کمتر از 80 درصد از مکمل تجویز شده)
    واکنش و حساسیت به مکمل تجویز شده
    عدم مراجعه فرد در مراحل مختلف مطالعه
    ابتلا به سردرد های تنشی
    ابتلا به بیماری های قلبی و عروقی، فشار خون بالا، دیابت، بیماری‌های کبدی، کلیوی، بدخیمی ها و سایر اختلالات عصبی
    بارداری و شیردهی
    مصرف مکمل‌های تغذیه ای (شامل ریبوفلاوین، feverfew، منیزیم و کوآنزیم Q10 در 3 ماه اخیر)
    پیروی از رژیم غذایی خاص
    استعمال دخانیات
    عدم تبعیت از توصیه ها و مکمل غذایی ( مصرف کمتر از 80 درصد از مکمل تجویز شده)
    واکنش و حساسیت به مکمل تجویز شده
    عدم مراجعه فرد در مراحل مختلف مطالعه
    ابتلا به سردرد های تنشی
    ابتلا به بیماری های اختلالات گوارشی مانند کرون و کولیت اولسراتی و سایر اختلالات عصبی
    بارداری و شیردهی
    مصرف مکمل‌های تغذیه ای (شامل پره بیوتیک و پروبیوتیک در 3 ماه اخیر)
    پیروی از رژیم غذایی خاص
    مصرف آنتی بیوتیک و آنتی اسید در سه ماه گذشته

  • Primary outcomes

    #1
    Serum levels of Zonulin
    empty
    سطوح سرمی زنولین
    empty
    At baseline and after 12 weeks
    empty
    در ابتدای مطالعه و پس از 12 هفته
    empty
    Enzyme-linked immunosorbent assay (ELISA) kits
    empty
    کیت الایزا
    empty
    #2
    Serum levels of High sensitive C-reactive protein (Hs-CRP)
    empty
    سطوح سرمی Hs-CRP
    empty
    At baseline and after 12 weeks
    empty
    در ابتدای مطالعه و پس از 12 هفته
    empty
    Enzyme-linked immunosorbent assay (ELISA) kits
    empty
    کیت الایزا
    empty
    #3
    Serum Nitric Oxide
    empty
    نیتریک اکساید سرمی
    empty
    At baseline and after 12 weeks
    empty
    در ابتدای مطالعه و پس از 12 هفته
    empty
    biochemical kit of KiaZist Co.
    empty
    کیت بیوشیمیایی کیازیست
    empty
    #4
    Total antioxidant capacity
    empty
    ظرفیت تام آنتی اکسیدانی
    empty
    At baseline and after 12 weeks
    empty
    در ابتدای مطالعه و پس از 12 هفته
    empty
    biochemical kit of KiaZist Co.
    empty
    کیت بیوشیمیایی کیازیست
    empty
    #5
    Total oxidant status
    empty
    وضعیت کلی اکسیدانی
    empty
    At baseline and after 12 weeks
    empty
    در ابتدای مطالعه و پس از 12 هفته
    empty
    biochemical kit of KiaZist Co.
    empty
    کیت بیوشیمیایی کیازیست
    empty

  • Secondary outcomes

    #1
    empty
    Serum levels of Zonulin
    empty
    سطوح سرمی زنولین
    empty
    At baseline and after 12 weeks
    empty
    در ابتدای مطالعه و پس از 12 هفته
    empty
    Enzyme-linked immunosorbent assay (ELISA) kits
    empty
    کیت الایزا
    #2
    empty
    serum levels of High sensitive C-reactive protein (Hs-CRP)
    empty
    سطوح سرمی Hs-CRP
    empty
    At baseline and after 12 weeks
    empty
    در ابتدای مطالعه و پس از 12 هفته
    empty
    Enzyme-linked immunosorbent assay (ELISA) kits
    empty
    کیت الایزا
    #3
    empty
    Serum Nitric Oxide
    empty
    نیتریک اکساید سرمی
    empty
    At baseline and after 12 weeks
    empty
    در ابتدای مطالعه و پس از 12 هفته
    empty
    Enzyme-linked immunosorbent assay (ELISA) kits
    empty
    کیت الایزا
    #4
    empty
    Total antioxidant capacity
    empty
    ظرفیت تام آنتی اکسیدانی
    empty
    At baseline and after 12 weeks
    empty
    در ابتدای مطالعه و پس از 12 هفته
    empty
    biochemical kit of KiaZist Co.
    empty
    کیت بیوشیمیایی کیازیست
    #5
    empty
    Total oxidant status
    empty
    وضعیت کلی اکسیدانی
    empty
    At baseline and after 12 weeks
    empty
    در ابتدای مطالعه و پس از 12 هفته
    empty
    biochemical kit of KiaZist Co.
    empty
    کیت بیوشیمیایی کیازیست

  • Recruitment centers

    #1
    Name of recruitment center - English: Neurology clinic of Al-Zahra Hospital
    Name of recruitment center - Persian: کلینیک مغز و اعصاب بیمارستان الزهرا
    Full name of responsible person - English: Dr. Gholamreza Askari
    Full name of responsible person - Persian: غلامرضا عسکری
    Street address - English: khorshid medical educational research complex, Ostandari Street, Isfahan
    Street address - Persian: اصفهان- خیابان استانداری- مجتمع آموزشی درمانی وپژوهشی خورشید
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8145833117
    Phone: +98 31 3222 2127
    Fax:
    Email: Askari@mui.ac.ir
    Web page address:
    Name of recruitment center - English: Neurology clinic
    Name of recruitment center - Persian: کلینیک مغز و اعصاب
    Full name of responsible person - English: Dr. Gholamreza Askari
    Full name of responsible person - Persian: غلامرضا عسکری
    Street address - English: khorshid medical educational research complex, Ostandari Street, Isfahan
    Street address - Persian: اصفهان- خیابان استانداری- مجتمع آموزشی درمانی وپژوهشی خورشید
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8145833117
    Phone: +98 31 3222 2127
    Fax:
    Email: Askari@mui.ac.ir
    Web page address:

Protocol summary

Study aim
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 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.
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
Exclusion criteria are very restricting, which may affect the credibility and universality of the study results
Acronym
IRCT registration information
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
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 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
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

Secondary outcomes

1

Description
Depression, stress, anxiety
Timepoint
At baseline and after 12 weeks
Method of measurement
DASS-21questionnaire

2

Description
Quality of Life in Migraine Patients
Timepoint
At baseline and after 12 weeks
Method of measurement
Migraine –Specific Quality of Life (MSQ) questionnaire

3

Description
Physical activity
Timepoint
At baseline and after 12 weeks
Method of measurement
International Physical Activity Questionnaire (IPAQ)

4

Description
Anthropometric indices
Timepoint
At baseline and after 12 weeks
Method of measurement
Seca scale and portable stadiometer

5

Description
Serum levels of Zonulin
Timepoint
At baseline and after 12 weeks
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits

6

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

7

Description
Serum Nitric Oxide
Timepoint
At baseline and after 12 weeks
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits

8

Description
Total antioxidant capacity
Timepoint
At baseline and after 12 weeks
Method of measurement
biochemical kit of KiaZist Co.

9

Description
Total oxidant status
Timepoint
At baseline and after 12 weeks
Method of measurement
biochemical kit of KiaZist Co.

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
Neurology 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
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