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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20161022030424N13
Enrollment
150
Registered
2025-06-07
Start date
2025-07-06
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis. Primary gonarthrosis, bilateral

Interventions

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, maintain

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Dolatkhah

Tabriz University of Medical Sciences

neda_dolatkhah@yahoo.com+98 41 3334 7054

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026