This study aims to evaluate the effects of Mediterranean and Paleolithic dietary interventions on nutritional status, disease activity, fatigue, sleep, and quality of life in adults with rheumatoid arthritis (RA). Participants aged 40-60 years will be randomly assigned to follow either a Mediterranean diet, a Paleolithic diet, or continue their usual diet for 12 weeks. The study will assess anthropometric measurements, disease activity score (DAS28), laboratory biomarkers (CBC, CRP, ESR, lipid profile, fasting glucose, HbA1c), and patient-reported outcomes. The trial will determine whether these diets improve RA management and overall well-being.
Patients classified as having rheumatoid arthritis according to the 2010 rheumatoid arthritis ACR/ EULAR classification criteria with a selected age group of 40 to 60 years old.
Patients with comorbidities (e.g., diabetes mellitus, hypertension, gout, thyroid dysfunction).
Parallel
Mediterranean Diet (MD)
Other interventionParticipants will follow a Mediterranean diet for 12 weeks, emphasizing fruits, vegetables, whole grains, legumes, fish, and olive oil, with limited red meat and processed foods. Nutritional counseling and meal plans will be provided.
Paleolithic Diet (PD)
Other interventionParticipants will follow a Paleolithic diet for 12 weeks, focusing on lean meats, fish, fruits, vegetables, eggs, nuts, and seeds, while excluding grains, legumes, dairy, processed foods, refined sugars, and added salt. Nutritional counseling and meal plans will be provided.
Control (Usual Diet)
Other interventionParticipants will continue their habitual diet without specific dietary modifications. General healthy eating advice may be provided.
Compare the effect of mediterranean diet and plaeolithic diet on the rate of change in the Rheumatoid Arthritis Disease Activity Score-28 (DAS-28 score)
Disease activity will be evaluated using the Disease Activity Score based on 28 joints (DAS-28), a validated composite index that includes the number of tender and swollen joints (28-joint count), erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global health assessment. The DAS-28 score ranges from 0 to 9.4, with higher scores indicating greater disease activity. The rate of change will be determined by calculating the difference in DAS-28 scores from baseline to the end of the intervention period (12 weeks) and comparing the mean change between the Mediterranean diet and Paleolithic diet groups.
Compare the effect of mediterranean diet and plaeolithic diet on rate of change of World Health Organization quality of life questionnaire (WHOQOL-BREF)
Quality of life will be assessed using WHOQOL-BREF, a validated instrument that evaluates four domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life. The rate of improvement will be determined by calculating the change in domain and total scores from baseline to the end of the intervention period (12 weeks) and comparing the mean change between the Mediterranean diet and Paleolithic diet groups.
Compare the effect of mediterranean diet and plaeolithic diet on incidence of sarcopenia according to the European Working Group on Sarcopenia in Older People (EWGSOP2, 2019)
Sarcopenia will be defined according to EWGSOP2 criteria as the presence of low muscle strength and low muscle mass. Low muscle strength will be assessed by handgrip dynamometry (\<27 kg in men and \<16 kg in women). Low muscle mass will be measured using bioelectrical impedance analysis (BIA) and expressed as appendicular skeletal muscle mass index (ASMI), with cut-off values of \<7.0 kg/m² in men and \<5.5 kg/m² in women. Physical performance will be evaluated using gait speed (≤0.8 m/s) to classify severe sarcopenia. Incidence will be defined as the proportion of participants who develop sarcopenia during the intervention period (from baseline to 12 weeks).
Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change of the body mass index (BMI)
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Body weight and height will be measured using standardized procedures. The rate of change in BMI will be determined by calculating the difference between baseline and the end of the intervention period (\[insert duration, e.g., 12 weeks\]) and comparing the mean change between the Mediterranean diet and Paleolithic diet groups.
Compare the effect of the Mediterranean diet and the Paleolithic diet on the rate of change in Waist-to-Hip Ratio (WHR)
Waist circumference (cm) and hip circumference (cm) will be measured using a non-stretchable measuring tape according to standardized protocols. Waist-to-hip ratio (WHR) will be calculated as waist circumference divided by hip circumference. The rate of change in WHR will be determined by calculating the difference between baseline and the end of the intervention period (12 weeks) and comparing the mean change between the Mediterranean diet and Paleolithic diet groups.
Compare the effect of the Mediterranean diet and Plaeolithic diet on the rate of change in muscle mass assessed by Bioelectrical Impedance Analysis (BIA)
Muscle mass will be assessed using bioelectrical impedance analysis (BIA) under standardized conditions. Appendicular skeletal muscle mass index (ASMI, kg/m²) will be calculated as appendicular skeletal muscle mass divided by height squared. The rate of change in ASMI will be determined by calculating the difference between baseline and the end of the intervention period (12 weeks) and comparing the mean change between the Mediterranean diet and Paleolithic diet groups.
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