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IRCT20220920055995N1 IRCT 2023-06-27 Shiraz University of Medical Sciences The effect of Mediterranean diet and the traditional food recommendation on fatigue and depression in 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 2023-02-20 anticipated 90 Complete https://irct.ir/trial/65991 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A Multiple sclerosis. Intervention 1: The first intervention group: During two months, patients participate twice in a 20-minute consultation program with the content of the principles of the Mediterranean diet. It will be taught using the Mediterranean diet questionnaire, a 13-question universal questionnaire. The Mediterranean diet emphasizes daily consumption of olives and olive oil, nuts, a high intake of legumes, grains including potatoes and bread, fruits and vegetables, a low consumption of red meat and meat products, and a moderate consumption of milk and dairy products. Patients will be educated on the 13 recommendations and given an educational pamphlet. It is recommended, for example, how many olives to eat per day, how many fruits to eat, and which foods to avoid. At first, the study will use a questionnaire to determine adherence to the Mediterranean diet. Intervention 2: The second intervention group: During two months, patients participate twice in a 20-minute consultation program with the content of the principles of traditional medicine's food pattern (hot and cold foods). 4 Dietary recommendations will be given to patients based on the findings of Sharifi et al.'s study of the dietary pattern in MS patients in Shiraz and the Rezapour study in Tehran. The four important dietary recommendations are as follows: consume two units of nuts per day, only one unit of sweets per day, four units of hot fruits per day, and avoid flavors such as vinegar and pickles. Patients will be given an educational pamphlet. Intervention 3: The control group: During a two-month period, patients participate twice in a 20-minute counseling program with the content of healthy eating principles. All patients in this group will receive routine general nutrition education. For example, less salt and low-fat food consumption, less fast food consumption, and a regular physical activity program. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not necessary. It will be sent to other researchers if needed
public Mohammad Hossein Sharifi
Shiraz School of Medicine, Imam Hossein Square, Zand St., -Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3208 4028 mhsharifi1350@gmail.com Shiraz University of Medical Sciences scientific Mohammad Hossein Sharifi
Shiraz School of Medicine, Imam Hossein Square, Zand St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3208 4028 mhsharifi1350@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with definite diagnosis of multiple sclerosis Kurtzke Extended disability status score < 6 Complete the consent form for the research survey 16 years 55 years Both Patients with secondary or primary progressive multiple sclerosis Patient with pregnancy Patient receives corticosteroid drug. Patient has cardiovascular disease. Patient has malignant tumors. G35 Multiple sclerosis Lifestyle Lifestyle Lifestyle The first intervention group: During two months, patients participate twice in a 20-minute consultation program with the content of the principles of the Mediterranean diet. It will be taught using the Mediterranean diet questionnaire, a 13-question universal questionnaire. The Mediterranean diet emphasizes daily consumption of olives and olive oil, nuts, a high intake of legumes, grains including potatoes and bread, fruits and vegetables, a low consumption of red meat and meat products, and a moderate consumption of milk and dairy products. Patients will be educated on the 13 recommendations and given an educational pamphlet. It is recommended, for example, how many olives to eat per day, how many fruits to eat, and which foods to avoid. At first, the study will use a questionnaire to determine adherence to the Mediterranean diet. The second intervention group: During two months, patients participate twice in a 20-minute consultation program with the content of the principles of traditional medicine's food pattern (hot and cold foods). 4 Dietary recommendations will be given to patients based on the findings of Sharifi et al.'s study of the dietary pattern in MS patients in Shiraz and the Rezapour study in Tehran. The four important dietary recommendations are as follows: consume two units of nuts per day, only one unit of sweets per day, four units of hot fruits per day, and avoid flavors such as vinegar and pickles. Patients will be given an educational pamphlet The control group: During a two-month period, patients participate twice in a 20-minute counseling program with the content of healthy eating principles. All patients in this group will receive routine general nutrition education. For example, less salt and low-fat food consumption, less fast food consumption, and a regular physical activity program. Fatigue score in Krupp Fatigue Severity Questionnaire. Timepoint: At the beginning of the study and then 60 days after the intervention. Method of measurement: Fatigue Severity Scale ‎Krupp. Depression score from Beck depression questionnaire - short form. Timepoint: At the beginning of the study and then 60 days after the intervention. Method of measurement: Beck depression questionaire -short form. Shiraz University of Medical Sciences Approved 2022-11-09 Ethics committee of Shiraz University of Medical Sciences Shiraz School of Medicine, Imam Hossein Square Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)