Protocol summary
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Study aim
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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.
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Design
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A randomized, controlled clinical trial in 180 MS patients that were selected by stratified blocked randomization (based on MS type), followed for 6 months.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-11-16, 1397/08/25
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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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2018-01-20, 1396/10/30
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Expected recruitment end date
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2018-07-21, 1397/04/30
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Actual recruitment start date
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2018-01-20, 1396/10/30
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Actual recruitment end date
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2018-07-21, 1397/04/30
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Trial completion date
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2018-10-22, 1397/07/30
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Scientific title
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Effect of the dietary modification on the body mass index, body fat percent and clinical manifestations in patients with multiple sclerosis (MS).
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Public title
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The effect of dietary modification on multiple sclerosis.
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
160
Actual sample size reached:
180
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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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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2018-10-03, 1397/07/11
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1397.287
Health conditions studied
1
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Description of health condition studied
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Multiple Sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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Quality of life
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Timepoint
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At first, three months and six months later (end of intervention)
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Method of measurement
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Multiple Sclerosis Quality Of Life-54 items (MSQOL-54)
2
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Description
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Fatigue severity
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Timepoint
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At first, three months and six months later (end of intervention)
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Method of measurement
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Fatigue Severity Scale-9 items (FSS-9)
3
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Description
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Disease activity
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Timepoint
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At first, three months and six months later (end of intervention)
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Method of measurement
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Extended Disability Status Scale (EDSS)
4
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Description
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Number of attacks (Relapse rate)
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Timepoint
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At first, three months and six months later (end of intervention)
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Method of measurement
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Asking the patient by a neurologist
5
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Description
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Body Mass Index (BMI)
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Timepoint
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At first, three months and six months later (end of intervention)
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Method of measurement
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The equation of weight (in kilograms) divided by the square of height (in square meter)
6
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Description
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Weight
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Timepoint
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At first, three months and six months later (end of intervention)
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Method of measurement
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Digital scale
7
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Description
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Body fat percentage
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Timepoint
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At first, three months and six months later (end of intervention)
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Method of measurement
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Deurenberg Equation
Intervention groups
1
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Description
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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
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Category
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Behavior
2
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Description
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Control group: They continued their usual diet.
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Category
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Other
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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70
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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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Yes - There is 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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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is 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
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Title and more details about the data/document
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The obtained information from the study is presented to participants and other researchers as the best diet recommended by the researcher.
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When the data will become available and for how long
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Access to data takes place 10 months after the publication of results.
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To whom data/document is available
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Other researchers at universities and research institutes
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Under which criteria data/document could be used
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Data should only be used to advance the design of appropriate diets for MS.
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From where data/document is obtainable
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Corresponding author: a.moravej@mail.mui.ac.ir
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What processes are involved for a request to access data/document
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10 months after the publication of the related article, individuals can email their requests for the corresponding author. a.moravej@mail.mui.ac.ir
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Comments
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Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2021-04-10, 1400/01/21
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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empty
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Abstract of published paper
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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.