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IRCT20161022030424N2 IRCT 2018-04-23 Tabriz University of Medical Sciences The effect of anti-inflammatory compared with the low-calorie diet on anthropometric indecies, anxiety, depression, functional status, pain and quality of life and serum indices of inflammation and oxidative stress in overweight and obese women with knee osteoarthritis The effect of anti-inflammatory compared with the low-calorie diet on anthropometric indecies, anxiety, depression, functional status, pain and quality of life and serum indices of inflammation and oxidative stress in overweight and obese women with knee osteoarthritis 2018-04-03 anticipated 60 Complete https://irct.ir/trial/30089 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization to a low-calorie diet or an anti-inflammatory diet was done by an allocation sequence specified by computerized random-number generation (Blockrand in R version 3.4.0; R Project for Statistical Computing) by a statistician not included in intervention delivery or data collection, Blinding description: Participants did not learn of their diet group assignment. N/A Knee osteoarthritis. Intervention 1: Intervention group 1: Balanced diet (A) intervention to reduce the weight of half a kilogram a week will be deducted from the average 3-day energy received by the individual 500 kilocalories and the diet will be designed with the following distribution: Fat: Less than 30% calories, Carbohydrates: 60-55 Percentage of calories and protein: 10-15% calories. Intervention 2: Intervention group 2: Anti-inflammatory Diet Intervention (B)The anti-inflammatory diet on fresh fruits and vegetables is the largest portion of the diet that should be eaten in large amounts and in each meal, in different types and colors (two-thirds of dietary calories). 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 No more information.
public Neda Dolatkhah
Emam Reza Hospital, Golgasht, Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3336 1928 dolatkhahn@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Neda Dolatkhah
Emam Reza Hospital, Golgasht, Azadu Ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3336 1928 dolatkhahn@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of knee osteoarthritis by physicians (mild, moderate) Age 50 and older BMI 41-27 Has the cognitive ability to complete the learned forms of food The desire to participate in the study 50 years no limit Female Get daily calories less than 800 and more than 4200 kcal Follow a special food pattern for medical reasons or other reasons Infection with other inflammatory diseases, such as rheumatoid arthritis Diabetes Other musculoskeletal problems, including back pain Having a history of radiotherapy Intra-articular intra-articular injection 3 months ago Oral use (nonsteroidal anti-inflammatory drugs) from a week before entering the study Depression (gaining a score of more than 5 from the Geriatric Depression Scale, GDS-15) History of neurological diseases or drug use People who for any reason are not able to cooperate in completing questionnaires and plans Use of dietary supplements, diuretics or laxatives during the intervention period Participate in sports programs or change physical activity Performing physiotherapy in the last 3 months Use of nonsteroidal anti-inflammatory drugs during the study M17.1 Unilateral primary osteoarthritis of knee Treatment - Other Treatment - Other Intervention group 1: Balanced diet (A) intervention to reduce the weight of half a kilogram a week will be deducted from the average 3-day energy received by the individual 500 kilocalories and the diet will be designed with the following distribution: Fat: Less than 30% calories, Carbohydrates: 60-55 Percentage of calories and protein: 10-15% calories. Intervention group 2: Anti-inflammatory Diet Intervention (B)The anti-inflammatory diet on fresh fruits and vegetables is the largest portion of the diet that should be eaten in large amounts and in each meal, in different types and colors (two-thirds of dietary calories). Functional status and pain associated with osteoarthritis in the lower extremities. Timepoint: Before and after the intervention. Method of measurement: Western Ontario and McMaster (WOMAC). BMI. Timepoint: The beginning and the end of the study. Method of measurement: The result of dividing the weight into kilograms by squared height in meters. Waist. Timepoint: The beginning and the end of the study. Method of measurement: Strip meter. Hip circumference. Timepoint: The beginning and the end of the study. Method of measurement: Strip meter. Severity of anxiety. Timepoint: The beginning and the end of the study. Method of measurement: Two-part questionnaire of Spielberger's apparent and hidden anxiety. Depression rate. Timepoint: The beginning and the end of the study. Method of measurement: Beck Depression Inventory. The amount of pain. Timepoint: The beginning and the end of the study. Method of measurement: VAS (Visual Analogue Scale). Quality of Life. Timepoint: The beginning and the end of the study. Method of measurement: SF-36 quality of life questionnaire. Biochemical analysis of blood samples. Timepoint: The beginning and the end of the study. Method of measurement: Biochemical analysis of blood samples. Tabriz University of Medical Sciences Approved 2018-02-26 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgshest St, Azadi St,Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)