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IRCT20161022030424N13 IRCT 2025-06-07 Tabriz University of Medical Sciences 5:2 intermittent fasting diet with high protein content in knee osteoarthritis To investigate the effect of a 5:2 intermittent fasting diet with high protein content versus daily calorie restriction balanced diet on anthropometric indices, body composition analysis, functional status, pain intensity, and serum markers of inflammation and oxidative stress in overweight and obese postmenopausal women with knee osteoarthritis 2025-07-06 anticipated 150 Recruiting https://irct.ir/trial/84099 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: We will use a stratified block randomization method for allocation. The computer-generated code, created using SAS software version 8.01, will be used to create a randomized sequence by a statistician outside the project's research team. Randomization will be stratified based on body mass index and osteoarthritis severity (mild, moderate, and severe). Serially numbered, opaque, sealed packets will be used to ensure allocation, Blinding description: Blinding the patients is not feasible in this trial. A trained nutritionist will ban diet-related conversations between assessors and patients during the study. Outcome assessors and the person responsible for statistical analysis will be blinded to the type of interventions received until the end of the study. 3 Knee osteoarthritis. Intervention 1: Intervention group: 5:2 fasting diet with high-protein intermittent content for 4 months (This diet involves maintaining normal eating habits for five consecutive days a week, maintaining an energy intake range of 1,400 to 1,600 kcal/day for women. On the remaining two days, a light fasting diet is adopted, limiting daily energy intake to 600 kcal/day. The percentage of protein in daily calories consumed is designed to be 2 grams per kilogram of body weight on all days of the week.). Intervention 2: Control group: Balanced low-calorie diet (500 kcal is deducted from the average 3-day energy intake of the individual, and the diet will be designed with the following distribution: fat less than 30% of calories, carbohydrates 55-60% of calories, and protein 10-15% of 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 available.
public Neda Dolatkhah
Imam Reza Educational and Medical Center, opposite the Central Organization of the University, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences scientific Neda dolatkhah
Imam Reza Educational and Medical Center, opposite the Central Organization of the University, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 7054 neda_dolatkhah@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of knee osteoarthritis by a physical medicine specialist Stopping menstrual cycle naturally 12 months ago Body mass index of 25 kg/m2 and above Not having another inflammatory disease such as rheumatoid arthritis No intra-articular injection for the past 3 months No oral medication (nonsteroidal anti-inflammatory drugs) for one week prior to study entry. 40 years 70 years Female Daily calorie intake of less than 800 and more than 4200 kcal A deviation from a specific eating pattern due to medical or other reasons Use of dietary supplements, diuretics, or laxatives during the intervention period Participation in sports programs or changes in physical activity Failure to follow the recommended diet Use of weight-affecting medications M17.0 Primary gonarthrosis, bilateral Treatment - Other Treatment - Other Intervention group: 5:2 fasting diet with high-protein intermittent content for 4 months (This diet involves maintaining normal eating habits for five consecutive days a week, maintaining an energy intake range of 1,400 to 1,600 kcal/day for women. On the remaining two days, a light fasting diet is adopted, limiting daily energy intake to 600 kcal/day. The percentage of protein in daily calories consumed is designed to be 2 grams per kilogram of body weight on all days of the week.) Control group: Balanced low-calorie diet (500 kcal is deducted from the average 3-day energy intake of the individual, and the diet will be designed with the following distribution: fat less than 30% of calories, carbohydrates 55-60% of calories, and protein 10-15% of calories) Weight. Timepoint: Weight measurement at the beginning of the study (before the start of the intervention) and 1, 2, 3 and 4 months after the start of the intervention. Method of measurement: Seca digital scale. Body mass index. Timepoint: Body mass index measurement at the beginning of the study (before the start of the intervention) and 1, 2, 3 and 4 months after the start of the intervention. Method of measurement: Calculation. Body fat mass. Timepoint: Measurement of body fat mass at the beginning of the study (before the start of the intervention) and 4 months after the start of the intervention. Method of measurement: Body analyzer. Fat-free body mass. Timepoint: Measurement of fat-free body mass at the beginning of the study (before the start of the intervention) and 4 months after the start of the intervention. Method of measurement: Body analyzer. Pain intensity. Timepoint: Pain intensity measurement at the beginning of the study (before the start of the intervention) and 4 months after the start of the intervention. Method of measurement: Visual Analogue Scale. Functional status. Timepoint: Measurement of functional status at the beginning of the study (before the start of the intervention) and 4 months after the start of the intervention. Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC). High-sensitivity C-reactive protein (hsCRP) level. Timepoint: Measurement of high-sensitivity C-reactive protein (hsCRP) levels at the beginning of the study (before the start of the intervention) and 4 months after the start of the intervention. Method of measurement: Biochemical analysis. Total antioxidant capacity (TAC) level. Timepoint: Measurement of total antioxidant capacity (TAC) levels at the beginning of the study (before the start of the intervention) and 4 months after the start of the intervention. Method of measurement: Biochemical analysis. Malondialdehyde (MDA) level. Timepoint: Measurement of Malondialdehyde (MDA) levels at the beginning of the study (before the start of the intervention) and 4 months after the start of the intervention. Method of measurement: Biochemical analysis. Tabriz University of Medical Sciences Approved 2025-02-15 Ethics committee of Tabriz University of Medical Sciences Vice Chancellor for Research and Technology, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)