Effects of Dietary Modification Based on Complementary and Alternative Iranian Medicine in Patients with Secondary-Progressive Multiple Sclerosis

Assessing The Effect of Dietary Modification Based on Complementary and Alternative Iranian Medicine in Patients with Secondary-Progressive MS.

A randomized double-blind controlled clinical trial with two-arm parallel groups on 70 eligible patients (n of intevention= 35; n of control= 35)

The present study will be conducted in "577 hospital" and "Isfahan MS center". Stratified block randomization will be conducted for this trial. Blinding of participants and dieticians will not possible because of obvious differences between the intervention and control diet. The severity of clinical manifestations and the inflammation biomarkers will be measured before and after the intervention.

Inclusion criteria: secondary-progressive MS patients (diagnosed by a neurologist according to the expanded disability status scale) who have consented to participate in the study are aged between 18-60 years old and Receive vitamin D3 50000 IU orally per week. Exclusion criteria: patients who participate in other clinical trials have particular medical conditions (type 2 diabetes, COVID-19 infection), The occurrence of MS attack, Smoking (at least two cigarettes per day), and adhering to special diets or nutritional supplements.

This trial will have two parallel arms. The intervention group will receive a diet based on complementary and alternative Iranian medicine for 8 weeks (2 months). This diet contains 45-50% of energy from carbohydrates, 35% from fats, and 15-20% from proteins. The control group will continue their current diet and will receive healthy dietary recommendations and energy adjustment for 8 weeks (2 months).

Serum hs-CRP; serum ESR; quality of life; fatigue severity; pain severity; disease activity; gastrointestinal evaluation; anxiety; anthropometric indices (body weight, body mass index, percent of body fat, triceps skinfold thickness)

Stratified block randomization will be conducted for this trial. In the stratified block randomization method, an independent chain of random numbers (with block method) will be prepared for each stratum to assign participants of that stratum into two study groups (1. complementary/alternative diet group and 2. control group). Therefore, for each MS treatment plan determined by the neurologist (three common types of MS drugs; monoclonal antibodies, sphingosine-1-phosphate receptor modulators, and dimethyl fumarate), the random sequence will be prepared in a 1:1 ratio with letters A and B (for intervention and control groups, respectively). Random sequences will be extracted from the site (https://www.sealedenvelope.com/). The neurologist will determine the treatment plan of the participants, and therefore, the study group (A or B) will be determined based on the related random chain. Once the randomization has been made, each patient is given a code with which they will be identified throughout the study.

In this trial, blinding of participants and dieticians is not possible because of obvious differences between the intervention and control diet; however, each patient is given a code, and an employee outside of the research team will enter data into the computer in separate datasheets. Therefore, outcome assessors and data analysts will be blinded to treatment allocation.

The major part of the results will be available to individuals. Moreover, the datasets used and/or analyzed during the current study are available from the investigators, on reasonable request.

The data will become available 8 months after the results' publication.

The data/document is available for all individuals, on reasonable request.

The data/document must be used for conducting similar studies and therapeutic approaches, on reasonable request from the investigators.

mail to amimohs@gmail.com or a.moravej@mail.mui.ac.ir

The data will be sent as soon as possible, after receiving the request.