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IRCT20200929048876N1 IRCT 2020-10-01 Zanjan University of Medical Sciences Useful Diet in patients with knee osteoarthritis Effectiveness of Mediterranean and low fat diets compared with the regular pattern to improvement of symptoms in patients with knee osteoarthritis 2020-10-05 anticipated 120 Complete https://irct.ir/trial/51278 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 knee osteoarthritis. 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. Gholamreza Zarrinjoie
Valie-Asr Hospital, Shariati St
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3315 6300 Gholamreza.zarrinjooie@gmail.com Zanjan University of Medical Sciences scientific ِDr. Gholamreza Zarrinjoie
Valie-Asr Hospital, Shariati St
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3315 6300 Gholamreza.zarrinjooie@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) knee osteoarthritis patients according to the US rheumatologic association criteria patients with grade 1-3 Body mass inbex between 25-35 Iranian ethnicity age of 40-75 yrs 40 years 75 years Both history of joint replacement chronic disease such as inflammatory rheumatoid arthritis, cardiac, hepatic, kidney failure, cancer, acute myocardial infarct, type 1 and 2 diabetes mellitus, stroke, mental and nervous diseases and serious injuries injection or oral administration of corticosteroids for the past 6 month intake of alcohol and cigarette 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 people who are undergoing physiotherapy or had physiotherapy to reduce pain over the past month opioid consumption or non-steroid anti-inflammatory drugs on a daily and continuous basis M17 Osteoarthritis of knee 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 3 month. Method of measurement: scale. Severity of pain alterations by WOMAC (Western Ontario and McMaster Universities Arthritis) index. Timepoint: baseline and after 3 month. Method of measurement: WOMAC questionnaire. Severity of pain alterations by Visual analog scale (VAS) index. Timepoint: baseline and after 3 month. Method of measurement: VAS questionnaire. Zanjan University of Medical Sciences Approved 2020-01-17 Ethic committee of Zanjan University of Medical Sciences Azadi Blv Zanjan Zanjan Iran (Islamic Republic of)