Study of the Effect of Diet on Rheumatoid Arthritis

INTERVENTION: Group 1: Intervention Group: Participants with a confirmed diagnosis of Rheumatoid Arthritis (RA) according to the EULAR/ACR criteria were recruited from the registry of the Department of Rheumatology at a university hospital. Participants in Arm 1 underwent a 90‐day Mediterranean Diet intervention. Baseline measurements (demographic, clinical, anthropometric, biochemical) were collected at baseline (T0) prior to intervention exposure, although post‐randomization. Clinical disease activity (DAS28‐ESR, DAS28‐CRP, Patient Global Activity, HAQ score), body composition, and inflammatory markers (CRP, ESR) were assessed at T0 and T90 (90 days). A predefined biomarker sub‐study (N=50) measured 5 serum adipokines (adiponectin, visfatin, leptin, resistin, adipsin) at T0 and T90. Group 2: Control Group: Participants with a confirmed diagnosis of Rheumatoid Arthritis (RA) according to the EULAR/ACR criteria were recruited from the registry of the Department of Rheumatology at a university hospital. Participants in Arm 2 underwent no dietary intervention. Baseline measurements (demographic, clinical, anthropometric, biochemical) were collected at baseline (T0) prior to intervention exposure, although post‐randomization. Clinical disease activity (DAS28‐ESR, DAS28‐CRP, Patient Global Activity, HAQ score), body composition, and inflammatory markers (CRP, ESR) were assessed at T0 and T90 (90 days). A predefined biomarker sub‐study (N=50) measured 5 serum adipokines (adiponectin, visfatin, leptin, resistin, adipsin) at T0 and T90. CONDITION: ; M05 Seropositive rheumatoid arthritis PRIMARY OUTCOME: WHAT: Rheumatoid arthritis clinical disease activity, evaluated via DAS28‐CRP (Disease Activity Score 28 using C‐Reactive Protein).; WHEN: Measured at baseline (T0) and 90 days post‐intervention (T90).; HOW: Data were collected by trained personnel using standardized clinical assessments, physical evaluations and standard laboratory measurements. SECONDARY OUTCOME: 1. Clinical disease activity: DAS28‐ESR (Disease Activity Score 28 using Erythrocyte Sedimentation Rate) and PGA (Patient Global Activity). ; 2. Standard systemic inflammatory markers (C‐reactive protein: CRP; erythrocyte sedimentation rate: ESR). Measured at baseline (T0) and 90 days (T90) via blood sample analysis. ; 3. Patient reported outcomes (PRO) [Health Assessment Questionnaire (HAQ‐DI) to assess functional disability] and the 36‐item Short Form Health Survey (SF‐36) Physical Component Summary (PCS) and Mental Component Summary (MCS) to assess quality of life. Measured at baseline (T0) and 90 days (T90) ; 4. Anthropometric parameters: Body weight, Body Mass Inde X(BMI), and body fat percentage. Measured at baseline (T0) and 90 days (T90) using calibrated instruments. ; 5. Exploratory Biomarker Sub‐study: Serum adipokine profile including Adiponectin (anti‐inflammatory), Visfatin, Leptin, Resistin, and Adipsin (pro‐inflammatory). Measured at baseline (T0) and 90 days (T90) using enzyme‐linked immunosorbent assay (ELISA). INCLUSION CRITERIA: ‐ Confirmed diagnosis of Rheumatoid Arthritis (RA) according to the ACR/EULAR 2010 classification criteria. ‐ Ability to fully comprehend the study protocol. ‐ Provision of written informed consent prior to participation.