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The effects of DASH (Dietary approach to stop hypertension) diet on severity, frequency, duration of headache and markers of oxidative stress in migraine patients

Protocol summary

Study aim
The effects of DASH (Dietary approach to stop hypertension) diet on severity, frequency, duration of headache and markers of oxidative stress in migraine patients.
Design
Patients will be randomly divided into two groups. Randomization will be done by permuted block randomization method. This study is a two arm parallel group, randomized clinical trial.
Settings and conduct
The study sites of Khorshid and Imam Musa Sadr Clinics are affiliated with Isfahan University of Medical Sciences. The subjects will be randomly divided into two groups of 50 each. The intervention group will receive the DASH diet and the control group will receive the control diet contain healthy dietary advises.
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; Body mass index 18.5-30 kg/m2; Exclusion criteria: Men with migraine; Migraine with Aura, Cardiovascular disease, hypertension, Diabetes, Liver disease, Kidney disease, Thyroid disorders, Malignancies and other neurological disorders; Pregnancy and Lactation.
Intervention groups
In this study, 100 people will be included among those with migraine and considering the inclusion and exclusion criteria. For 3 months, the intervention group will receive the DASH diet and the control group will receive the control diet contain healthy dietary advises. DASH diet consist of fruits, vegetables, whole grain and low fat dairy. Control diet includes healthy dietary recommendation based upon dietary pyramid.
Main outcome variables
Migraine Severity Score; Migraine Duration; Migraine Frequency; Headache Impact test; Serum Nitric Oxide; Vitamin C; Serum Glutathione; Total Oxidative Capacity; Total Antioxidant Capacity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011763N38
Registration date: 2019-10-01, 1398/07/09
Registration timing: prospective

Last update: 2019-10-01, 1398/07/09
Update count: 0
Registration date
2019-10-01, 1398/07/09
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
2019-11-21, 1398/08/30
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of DASH (Dietary approach to stop hypertension) diet on severity, frequency, duration of headache and markers of oxidative stress in migraine patients
Public title
Dietary approach to stop hypertension (DASH) diet in migraine
Purpose
Supportive
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 Body mass index between 18.5-30 kg/m2
Exclusion criteria:
Men with migraine Migraine with aura Diagnosis of other disease such as cardiovascular disease, hypertension, diabetes, liver disease, kidney disease, thyroid disorders, malignancies and other neurological problem Pregnancy and lactation
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on permuted block randomization method. Each block will 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 number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-09-14, 1398/06/23
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.352

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura

Primary outcomes

1

Description
Migraine severity
Timepoint
At baseline and after 12 weeks
Method of measurement
Visual analogue scale

2

Description
Migraine frequency
Timepoint
At baseline and after 12 weeks
Method of measurement
Clinical examination

3

Description
Migraine duration
Timepoint
At baseline and after 12 weeks
Method of measurement
Clinical examination

4

Description
Headache impact test
Timepoint
At baseline and after 12 weeks
Method of measurement
HIT questionnaire

5

Description
Serum Nitric Oxide
Timepoint
At baseline and after 12 weeks
Method of measurement
Colorimetric method

6

Description
Serum vitamin C
Timepoint
At baseline and after 12 weeks
Method of measurement
Colorimetric method

7

Description
Total antioxidant capacity
Timepoint
At baseline and after 12 weeks
Method of measurement
Colorimetric method

8

Description
Total oxidant capacity
Timepoint
At baseline and after 12 weeks
Method of measurement
Colorimetric method

9

Description
Serum glutathion
Timepoint
At baseline and after 12 weeks
Method of measurement
Colorimetric method

Secondary outcomes

1

Description
Blood pressure
Timepoint
At baseline and after 12 weeks
Method of measurement
Sphygmomonometer

2

Description
Weight
Timepoint
At baseline and after 12 weeks
Method of measurement
Digital scale

Intervention groups

1

Description
Intervention group: Intervention group will receive DASH diet for 3 months. DASH diet have been designed to be included high levels of fruits, vegetables, whole grains and low fat dairy. In order to examine the adherence of participants to diet, serum levels of vitamin C have been assessed. Also, all of the assessment have been conducted at baseline and end of study
Category
Treatment - Other

2

Description
Control group: The control group will receive a 3-month control diet including healthy dietary advice. Healthy dietary recommendation includes healthy advises based on food guide pyramid.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorshid Clinic
Full name of responsible person
Gholamreza Askari
Street address
Ostandari Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir

2

Recruitment center
Name of recruitment center
Imam Musa Sadr Clinic
Full name of responsible person
Gholamreza Askari
Street address
Foroghi Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou
Street address
Hezarjarib Ave., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.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
Gholamreza Askari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
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
Arman Arab
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8317745181
Phone
+98 31 4525 1696
Email
arman4369@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Arman Arab
Position
Master of science
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8317745181
Phone
+98 31 4525 1696
Fax
Email
arman4369@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Major part of information will be available for population.
When the data will become available and for how long
12 months after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
To conduct similar studies
From where data/document is obtainable
En
What processes are involved for a request to access data/document
The data will send as soon as possible, after receiving the request.
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