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Study aim
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To determine the effect of a 5:2 intermittent fasting diet with high protein content compared to a balanced diet with daily calorie restriction 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.
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Design
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Controlled clinical trial, with parallel groups, single-blind, randomized, phase 3 on 150 patients
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Settings and conduct
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The patients will be selected from among female patients referred to the Physical Medicine Clinic of Imam Reza Hospital in Tabriz with a diagnosis of knee osteoarthritis using a convenience sampling method and will be randomly assigned to receive two balanced low-calorie diets and a 5:2 intermittent fasting diet for 4 months.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diagnosis of knee osteoarthritis by a physical medicine specialist
Stopping the 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 before study entry.
Exclusion criteria: 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
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Intervention groups
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Intervention group: 5:2 intermittent fasting diet with high protein content
Control group: Balanced low-calorie diet
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Main outcome variables
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Anthropometric indices, body composition, functional status, pain level, serum markers of inflammation, and oxidative stress