Evaluation of the effect of the nutritional recommendations based on Mediterranean diet and the traditional food recommendation to reduce the fatigue severity and depressive symptoms in patients with multiple sclerosis

Evaluation of the effect of the nutritional recommendations based on Mediterranean diet and the traditional food recommendation to reduce the fatigue severity and depressive symptoms in patients with multiple sclerosis

A concealed, randomized, blinded controlled clinical trial with a parallel group design of 90 patients, enrolled between February 2023 till July 2023

Patients with multiple sclerosis who visit Imam Reza Specialized Clinic, Shiraz, during the study will be enrolled and randomly assigned to intervention or control groups using the random block method. This will be a double-blind study, which means that neither the patients nor the doctor examining them, nor the data analyst, will be aware of the type of intervention.

Inclusion criteria: Definitive diagnosis of multiple sclerosis; Expanded Disability Status Scale should be less than 6; patients aged 16 to 55 years; Exclusion criteria: Patients with secondary or primary progressive multiple sclerosis, pregnancy, cardiovascular diseases

The first intervention group receives 20-minute face-to-face educational counseling twice a month for two months in order to increase adherence to the Mediterranean diet, as well as an educational pamphlet. The second intervention group received 20-minute face-to-face educational counseling over two months to increase adherence to four nutritional recommendations based on nutritional principles of traditional Iranian medicine (the nature of food in Sharifi et al.'s research). Patients in the third group (control group) receive healthy general nutritional advice during two months of face-to-face educational counseling for 20 minutes. Patients in all groups receive their standard drug treatment.

Fatigue and depression score

A randomized block design will be used. The random sequence will be generated using the online software ( Create a blocked randomization list | Sealed Envelope). We will use blocks with sizes of 3, 6, and 12. In addition, a fully sealed envelope covered with carbon paper will be used to conceal the allocation. The statistics specialist will prepare the concealment envelopes, which will remain hidden until the grouping training course is held.

Stages of study blinding: Both participants and researchers or outcome assessors in this study are unaware of study group allocation. Everyone involved in the study assumed that all three groups of participants would receive the educational intervention. The clinical caregiver will conduct educational sessions for all patients, introduce the study groups in general, and explain the study's objectives to the patients. The patient-educator and the duration-place will be the same. The educational counseling structure will be the same for all patients, but educational clauses corresponding to the intervention group will be added to the educational structure in the first, second, and third intervention groups. The clinical caregiver is unaware of the patient grouping. The neurologist introduces the patients to the research group after assessing their eligibility for participation in the study. The neurologist has no concept which patients belong to which groups. Based on the block randomization, the clinical supervisor of the study will assign patients to the first, second, and third groups, and then complete fatigue and depression assessment questionnaires for all patients. In the first group, a clinical caregiver will assess patients' adherence to the Mediterranean diet, and then the patient will receive specialized training in the field of increasing adherence to the Mediterranean diet. The patient will also be given an educational pamphlet. This group's clinical caregiver is unaware of the second and third groups. In the second intervention group, a clinical caregiver will first complete the three-day food record questionnaire before providing patients with dietary recommendations based on food traditional medicine (nature of food).This group's clinical caregiver is unaware of the first and third groups. The final group (control group) receives general healthy nutritional advice from a clinical caregiver. This group's clinical caregiver is unaware of the first and second groups. After 8 weeks, the second researcher will complete the main outcome of the study, the fatigue and depression assessment questionnaire for all patients, without knowing the grouping of the participants, and enter the data into the software. A statistician will analyze the data. The statistician is unaware of the study's grouping. Based on the analysis, the primary researcher of the study will draft the article. The primary researcher is aware of the grouping.

The title of the proposal and the working method can be published

Access to data is possible after 6 months from the publication of the article.

Researchers in the field of medical sciences are allowed access

If a scientific paper is going to be published using the data of this research, it is necessary to mention the name of the researchers of this project.

To get information, it is necessary to refer to the first researcher: • Mohammad Hossein Sharifi, Assistant Professor, MD and Ph.D in nutrition, Shiraz University of Medical Sciences, Shiraz, Iran. sharifimh@sums.ac.ir

After receiving the request email, the cooperation form is signed between the two parties. Then the data will be sent within 10 working days