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Recruitment centers
#1
Name of recruitment center - English: M.S Isfahan Center
Name of recruitment center - Persian: مرکز ام اس اصفهان
Full name of responsible person - English: Ahmad Chitsaz
Full name of responsible person - Persian: احمد چیت ساز
Street address - English: Hedayat St, Bahonar St, Isfahan
Street address - Persian: اصفهان، خیابان باهنر، خیابان هدایت
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8138613691
Phone: +98 31 3345 8887
Fax:
Email: chitsaz@med.mui.ac.ir
Web page address:
Name of recruitment center - English: M.S Isfahan Center
Name of recruitment center - Persian: مرکز ام اس اصفهان
Full name of responsible person - English: Ahmad Chitsaz
Full name of responsible person - Persian: احمد چیت ساز
Street address - English: Hedayat St, Bahonar St, Isfahan
Street address - Persian: اصفهان، خیابان باهنر، خیابان هدایت
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81386-13691
Phone: +98 31 3345 8887
Fax:
Email: chitsaz@med.mui.ac.ir
Web page address:
Name of recruitment center - English: M.S Isfahan Center Name of recruitment center - Persian: مرکز ام اس اصفهان Full name of responsible person - English: Ahmad Chitsaz Full name of responsible person - Persian: احمد چیت ساز Street address - English: Hedayat St, Bahonar St, Isfahan Street address - Persian: اصفهان، خیابان باهنر، خیابان هدایت City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 813861369181386-13691 Phone: +98 31 3345 8887 Fax: Email: chitsaz@med.mui.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shaghayegh Haghjooy Javanmard
Full name of responsible person - Persian: شقایق حق جوی جوانمرد
Street address - English: Isfahan University of Medical Sciences, Hezar jerib St
Street address - Persian: خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 7346181746
Phone: +98 31 3792 9595
Fax:
Email: sh_haghjoo@med.mui.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shaghayegh Haghjooy Javanmard
Full name of responsible person - Persian: شقایق حق جوی جوانمرد
Street address - English: Isfahan University of Medical Sciences, Hezar Jerib Ave
Street address - Persian: خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 73461-81746
Phone: +98 31 3792 9595
Fax:
Email: sh_haghjoo@med.mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Shaghayegh Haghjooy Javanmard Full name of responsible person - Persian: شقایق حق جوی جوانمرد Street address - English: Isfahan University of Medical Sciences, Hezar jerib StJerib Ave Street address - Persian: خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 734618174673461-81746 Phone: +98 31 3792 9595 Fax: Email: sh_haghjoo@med.mui.ac.ir Web page address:
ietary modification may improve quality of life and fatigue severity in Multiple Sclerosis (MS) patients. Given this, there is a growing interest in healthy diets, especially Mediterranean based. The goal of this study was to explore the effects of a modified Mediterranean (mMeD) dietary intervention in Quality Of Life (QOL), and severity of fatigue in MS participants. About 180 Relapsing-Remitting MS patients randomly assigned to follow/not follow the mMeD for 6 months. Primary endpoints were related to dietary adherence and study completion. Clinical endpoints were evaluated Multiple Sclerosis Quality Of Life-54 items, Fatigue Severity Scale (FSS-9), and Visual Analog Fatigue Scale. Data were analyzed by SPSS 24. Of 261 screened patients (July 2018–February 2019), 180 were eligible and willing to commit. 68/90 as mMeD and 79/90 as control group completed the study. Self-reported adherence was excellent (95%). The majority of mean changes for QOL were statistically significant (P < .001). As well, Mean change on the FSS-9 was −9.8 ± 11.5 compared to +0.3 ± 4.2 for controls (P < .001). This regimen improved fatigue and some components of QOL in RRMS patients. Larger scale and longer duration trials to assess the role of diet as a disease modifier in MS should be conducted.
ietary modification may improve quality of life and fatigue severity in Multiple Sclerosis (MS) patients. Given this, there is a growing interest in healthy diets, especially Mediterranean based. The goal of this study was to explore the effects of a modified Mediterranean (mMeD) dietary intervention in Quality Of Life (QOL), and severity of fatigue in MS participants. About 180 Relapsing-Remitting MS patients randomly assigned to follow/not follow the mMeD for 6 months. Primary endpoints were related to dietary adherence and study completion. Clinical endpoints were evaluated Multiple Sclerosis Quality Of Life-54 items, Fatigue Severity Scale (FSS-9), and Visual Analog Fatigue Scale. Data were analyzed by SPSS 24. Of 261 screened patients (July 2018–February 2019), 180 were eligible and willing to commit. 68/90 as mMeD and 79/90 as control group completed the study. Self-reported adherence was excellent (95%). The majority of mean changes for QOL were statistically significant (P < .001). As well, Mean change on the FSS-9 was −9.8 ± 11.5 compared to +0.3 ± 4.2 for controls (P < .001). This regimen improved fatigue and some components of QOL in RRMS patients. Larger scale and longer duration trials to assess the role of diet as a disease modifier in MS should be conducted.
Protocol summary
Study aim
Determine the effect of dietary modification on body mass index, body weight, body fat percent, quality of life, disease activity, number of attacks and fatigue severity in patients with multiple sclerosis (MS) with controlling type and dose, calorie intake, age, Sex, educational level, duration of MS and family history of MS.
Design
A randomized, controlled clinical trial in 180 MS patients that were selected by stratified blocked randomization (based on MS type), followed for 6 months.
Settings and conduct
This study was done in MS Isfahan clinic. After placement of subjects into intervention and control groups, the intervention group undergoes a modified Mediterranean-like diet. Four sessions were formed for training each subject. The variables were measured three times.
Participants/Inclusion and exclusion criteria
The inclusion criteria were: aged between 20-60 years, basic literacy, writing ability and memory strength, and favorable mental condition for continuing study.
The exclusion criteria were: participation in other clinical trials, having other acute diseases, waiting for abdominal surgery, receiving supplements or corticosteroid therapy, and cigarette smoking, regularly.
Intervention groups
Intervention group: Education of Mediterranean-like diet, in four sessions for each subject by a skilled nutritionist and following-up diet adherence by a trained researcher, monthly. Control group: Continuing usual diet without any intervention.
Main outcome variables
Quality of life; fatigue severity; disease activity; relapse rate; energy intake; family history of multiple sclerosis; duration of multiple sclerosis; height; weight; Body Mass Index (BMI); body fat; age; gender; education level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181113041641N1
Registration date:2018-11-16, 1397/08/25
Registration timing:retrospective
Last update:2021-04-10, 1400/01/21
Update count:1
Registration date
2018-11-16, 1397/08/25
Registrant information
Name
Amir Reza Moravejolahkami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3335 4453
Email address
a.moravej@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
2018-01-20, 1396/10/30
Actual recruitment end date
2018-07-21, 1397/04/30
Trial completion date
2018-10-22, 1397/07/30
Scientific title
Effect of the dietary modification on the body mass index, body fat percent and clinical manifestations in patients with multiple sclerosis (MS).
Public title
The effect of dietary modification on multiple sclerosis.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60 years
Having basic literacy.
Writing ability and memory strength
Good mental conditions for the continuation of the study
Exclusion criteria:
Participating in other interventional studies at the same time.
Having the other acute and severe illness
Regular and periodic consumption of special dietary supplement or sport-specific diets
The full-dose intake of oral corticosteroides
Continues and daily cigarette smoking
People who are waiting for abdominal surgery
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Actual sample size reached:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized allocation was done by Stratified Blocked Randomization method. At first, participants (n=180) were classified into four categories according to the type of MS (relapsing-remitting, primary-progressive, secondary-progressive, progressive-relapsing). Subjects were then assigned to intervention and control groups - each one 90 patients - with blocked randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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 Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.287
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Quality of life
Timepoint
At first, three months and six months later (end of intervention)
Method of measurement
Multiple Sclerosis Quality Of Life-54 items (MSQOL-54)
2
Description
Fatigue severity
Timepoint
At first, three months and six months later (end of intervention)
Method of measurement
Fatigue Severity Scale-9 items (FSS-9)
3
Description
Disease activity
Timepoint
At first, three months and six months later (end of intervention)
Method of measurement
Extended Disability Status Scale (EDSS)
4
Description
Number of attacks (Relapse rate)
Timepoint
At first, three months and six months later (end of intervention)
Method of measurement
Asking the patient by a neurologist
5
Description
Body Mass Index (BMI)
Timepoint
At first, three months and six months later (end of intervention)
Method of measurement
The equation of weight (in kilograms) divided by the square of height (in square meter)
6
Description
Weight
Timepoint
At first, three months and six months later (end of intervention)
Method of measurement
Digital scale
7
Description
Body fat percentage
Timepoint
At first, three months and six months later (end of intervention)
Method of measurement
Deurenberg Equation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Following a Mediterranean-like diet consist of 17-15% protein with an emphasis on the consumption of fish and seafood, 45-47% carbohydrates with an emphasis on the consumption of whole grains and legumes, 35-32% total fat that only 9-10% of which contains saturated fat and most of it contains PUFA (especially omega-3) with an emphasis on oatmeal oil and flaxseed oil, and fiber (27-38 gr per day) for 6 months
Category
Behavior
2
Description
Control group: They continued their usual diet.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
M.S Isfahan Center
Full name of responsible person
Ahmad Chitsaz
Street address
Hedayat St, Bahonar St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81386-13691
Phone
+98 31 3345 8887
Email
chitsaz@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 9595
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
70
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
Amir Reza Moravejolahkami
Position
M. Sc student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 16, 27 st Stop street, Khademi St
City
Isfahan
Province
Isfehan
Postal code
81386-13691
Phone
+98 31 3335 4453
Email
a.moravej@mail.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Reza Moravejolahkami
Position
M. Sc. student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 16, 27 st Stop street, Khademi St.
City
Isfahan
Province
Isfehan
Postal code
81386-13691
Phone
+98 31 3335 4453
Email
a.moravej@mail.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Reza Moravejolahkami
Position
M. Sc. student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 16, 27 st Stop street, Khademi St.
City
Isfahan
Province
Isfehan
Postal code
81386-13691
Phone
+98 31 3335 4453
Email
a.moravej@mail.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The obtained information from the study is presented to participants and other researchers as the best diet recommended by the researcher.
When the data will become available and for how long
Access to data takes place 10 months after the publication of results.
To whom data/document is available
Other researchers at universities and research institutes
Under which criteria data/document could be used
Data should only be used to advance the design of appropriate diets for MS.
From where data/document is obtainable
Corresponding author: a.moravej@mail.mui.ac.ir
What processes are involved for a request to access data/document
10 months after the publication of the related article, individuals can email their requests for the corresponding author. a.moravej@mail.mui.ac.ir
Comments
Trial results
Please tick if results have been published
Yes
Summary result posting date
2021-04-10, 1400/01/21
Table of baseline comparison
Participant flow diagram
Table of variable outcomes' results
Table of adverse events
First publication date
empty
Abstract of published paper
ietary modification may improve quality of life and fatigue severity in Multiple Sclerosis (MS) patients. Given this, there is a growing interest in healthy diets, especially Mediterranean based. The goal of this study was to explore the effects of a modified Mediterranean (mMeD) dietary intervention in Quality Of Life (QOL), and severity of fatigue in MS participants. About 180 Relapsing-Remitting MS patients randomly assigned to follow/not follow the mMeD for 6 months. Primary endpoints were related to dietary adherence and study completion. Clinical endpoints were evaluated Multiple Sclerosis Quality Of Life-54 items, Fatigue Severity Scale (FSS-9), and Visual Analog Fatigue Scale. Data were analyzed by SPSS 24. Of 261 screened patients (July 2018–February 2019), 180 were eligible and willing to commit. 68/90 as mMeD and 79/90 as control group completed the study. Self-reported adherence was excellent (95%). The majority of mean changes for QOL were statistically significant (P < .001). As well, Mean change on the FSS-9 was −9.8 ± 11.5 compared to +0.3 ± 4.2 for controls (P < .001). This regimen improved fatigue and some components of QOL in RRMS patients. Larger scale and longer duration trials to assess the role of diet as a disease modifier in MS should be conducted.