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IRCT20200929048876N2 IRCT 2020-10-09 Zanjan University of Medical Sciences Useful Diet in patients with rheumatoid arthritis Assessment of the effects of Mediterranean and low fat diets compared with regular diet on improvement of symptoms in patients with rheumatoid arthritis 2020-02-19 anticipated 168 Complete https://irct.ir/trial/51303 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Blocked randomization will be used as three groups with 15-number blocks including 5 participant in each group. randomization unit is person and we will use random allocation software for this purpose. random coded boxes will be used for concealment. At this method, cans with similar weight, shape and color which are numbered according to the random sequence will be used, Blinding description: Nutritionist and patients are aware of grouping. The outcome analyzer will be blinded and has no knowledge about grouping. N/A rheumatoid arthiritis. Intervention 1: Intervention group: Mediterranean diet which contains 35% of calorie from fats, 15% from protein and 50% from carbohydrates. This diet contains 27-37 gr fiber per day. After calorie counting and dividing the calories according to the above percent, the patients emphasis to receive at least half of their grain and bread from whole form. They can eat 1 time red meat (150 gr) at each month. Their daily oil consumption is olive oil (for salad) and canola oil (for frying).The main meat is white meat and receive 2 capsules of omega-3 each week. At least, one unit of legumes (half a glass of cooked beans) and nuts will be included in the daily diet. Dairy is as low fat and 6 glass of water will consume each day. Intervention 2: Intervention group: low fat diet which contains 20% of calorie from fats, 15% from protein and 65% from carbohydrates. In this dietary pattern, we will not have any specific recommendation for patients and only required dietary servings for each patient will be determined according the above percent and will be provided for each patient. Intervention 3: Control group: conventional group without any changes in dietary patterns of participants. Yes - There is a plan to make this available What will be shared: without participant name When: after study final To whom: all persons Conditions: all persons Where to obtain: Zanjan University of Medical Sciences, Deputy of Research and Thechnology How to obtain: straight referee to Deputy of Research and Technology of Zanjan University of Medical Sciences Comments:
public Dr. Mojtaba Tabatabaiee Befroodi
Valie-Asr Hospital, Shariati St
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3315 6300 mojtabaaatabatabaeee@yahoo.com Zanjan University of Medical Sciences scientific Dr. Mojtaba Tabatabaiee Befroodi
Valie-Asr Hospital, Shariati St
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3315 6300 mojtabaaatabatabaeee@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Rheumatoid patients according to the US rheumatologic association criteria rheumatoid patients at the activated phase of disease body mass index between 25-35 age of 15-75 yrs Iranian ethnicity 15 years 75 years Both pregnant or lactating women or who decided to pregnant intake of multivitamins or minerals supplements at least at the last 3 month people who are on certain diets or have been on a diet for at the last 3 month people who don't follow the prescribed diets recent weight loss more than 4 kg during the last 2 month allergy and sensitivity to fish or impossibility of consuming it opioid consumption or non-steroid anti-inflammatory drugs on a daily and continuous basis patients at the remission phase of disease other chronic diseases except of rheumatoid arthritis intake of alcohol and cigarette maldigesting diseases such as celiac and steatorrhea M06.9 Rheumatoid arthritis, unspecified Rehabilitation Rehabilitation Placebo Intervention group: Mediterranean diet which contains 35% of calorie from fats, 15% from protein and 50% from carbohydrates. This diet contains 27-37 gr fiber per day. After calorie counting and dividing the calories according to the above percent, the patients emphasis to receive at least half of their grain and bread from whole form. They can eat 1 time red meat (150 gr) at each month. Their daily oil consumption is olive oil (for salad) and canola oil (for frying).The main meat is white meat and receive 2 capsules of omega-3 each week. At least, one unit of legumes (half a glass of cooked beans) and nuts will be included in the daily diet. Dairy is as low fat and 6 glass of water will consume each day. Intervention group: low fat diet which contains 20% of calorie from fats, 15% from protein and 65% from carbohydrates. In this dietary pattern, we will not have any specific recommendation for patients and only required dietary servings for each patient will be determined according the above percent and will be provided for each patient. Control group: conventional group without any changes in dietary patterns of participants. Weight changes. Timepoint: baseline and after 3month. Method of measurement: scale. Pain severity. Timepoint: baseline and after 3 month. Method of measurement: VAS and DAS28 questionnaire. Zanjan University of Medical Sciences Approved 2020-01-16 Ethic committee of Zanjan University of Medical Sciences Azadi Blv Zanjan Zanjan Iran (Islamic Republic of)