]>
IRCT20181113041641N1 IRCT 2018-11-16 Esfahan University of Medical Sciences The effect of dietary modification on multiple sclerosis. Effect of the dietary modification on the body mass index, body fat percent and clinical manifestations in patients with multiple sclerosis (MS). 2018-01-20 anticipated 160 Complete https://irct.ir/trial/35185 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, 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. N/A Multiple Sclerosis. Intervention 1: 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. Intervention 2: Control group: They continued their usual diet. https://www.tandfonline.com/doi/full/10.1080/10942912.2020.1840390 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. Yes - There is a plan to make this available What will be shared: The obtained information from the study is presented to participants and other researchers as the best diet recommended by the researcher. When: Access to data takes place 10 months after the publication of results. To whom: Other researchers at universities and research institutes Conditions: Data should only be used to advance the design of appropriate diets for MS. Where to obtain: Corresponding author: a.moravej@mail.mui.ac.ir How to obtain: 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:
public Amir Reza Moravejolahkami
No. 16, 27 st Stop street, Khademi St
Isfahan Iran (Islamic Republic of) 81386-13691 +98 31 3335 4453 a.moravej@mail.mui.ac.ir Esfahan University of Medical Sciences scientific Amir Reza Moravejolahkami
No. 16, 27 st Stop street, Khademi St.
Isfahan Iran (Islamic Republic of) 81386-13691 +98 31 3335 4453 a.moravej@mail.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 20-60 years Having basic literacy. Writing ability and memory strength Good mental conditions for the continuation of the study 20 years 60 years Both 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 G35 Multiple sclerosis Behavior Other 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 Control group: They continued their usual diet. 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). Fatigue severity. Timepoint: At first, three months and six months later (end of intervention). Method of measurement: Fatigue Severity Scale-9 items (FSS-9). Disease activity. Timepoint: At first, three months and six months later (end of intervention). Method of measurement: Extended Disability Status Scale (EDSS). 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. 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). Weight. Timepoint: At first, three months and six months later (end of intervention). Method of measurement: Digital scale. Body fat percentage. Timepoint: At first, three months and six months later (end of intervention). Method of measurement: Deurenberg Equation. Esfahan University of Medical Sciences Approved 2018-10-03 Ethics committee of Isfahan University of Medical Sciences Isfahan University Of Medical Sciences, Hezar Jerib Ave Isfahan Isfehan Iran (Islamic Republic of)