A New Approach to Nutritional Therapy in Rheumatoid Arthritis: Evaluation of the Effect of the DASH Diet Through a Randomized Controlled Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In this study, it is aimed to determine the effect of the DASH diet model on the treatment of patients with seropositive rheumatoid arthritis, by evaluating its potential impact on inflammatory markers, disease activity scores, patients' functional status in daily life, and quality of life. This study is being conducted as part of a doctoral dissertation, and due to insufficient initial awareness regarding the requirement for prior registration, the registration process was completed after data collection had already begun. However, data collection is still ongoing, and the study has not yet been completed. We remain committed to full compliance with clinical trial reporting standards and transparency.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• Voluntary acceptance to participate in the study, Being within the age range of 18-64 years, Having a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria and belonging to the seropositive rheumatoid arthritis subgroup, Being in the active phase of rheumatoid arthritis according to the DAS-28 CRP or DAS-28 ESR disease activity score, Having a disease duration of at least 1 year, Not having previously undergone any dietary treatment specific to rheumatoid arthritis, Not using any dietary supplements other than calcium and vitamin D3 supplementation (e.g., 1000 mg calcium, 880 IU vitamin D3) recommended by the physician for patients using glucocorticoids and folic acid supplementation (10 mg weekly) recommended for patients using methotrexate, Having stable use of disease-modifying anti-rheumatic drugs (≥3 months), corticosteroids (≥4 weeks), and nonsteroidal anti-inflammatory drugs (≥10 days) before starting the DASH diet treatment, with a daily oral corticosteroid dose not exceeding 12.5 mg of prednisolone, Not having a diagnosis of eating disorders, Not being pregnant or breastfeeding, Not using banned substances, Having no intellectual disability, Having no allergy and/or intolerance to the foods included in the DASH diet

Locations
Other Locations
Turkey
Başakşehir Çam and Sakura City Hospital
RECRUITING
Istanbul
Istanbul Prof. Dr. Cemil Taşcıoğlu City Hospital
COMPLETED
Istanbul
Contact Information
Primary
Gökçen ÖZÜPEK
gokcen_ozupek@hotmail.com
+90 542 212 35 30
Backup
Zeynep B KALYONCU ATASOY, AsstProf
z.begum.kalyoncu@gmail.com
+90 533 651 43 73
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2025-12
Participants
Target number of participants: 48
Treatments
Experimental: DASH Diet Group
Participants in this group will follow the DASH diet for 12 weeks. The diet will be tailored according to individual physical activity levels and basal metabolic rate. Dietary adherence will be monitored through dietary intake records and DASH diet scores calculated using the Nutrition Information System (BeBiS).
No_intervention: Control Group
Participants in this group will continue their usual diet without any dietary intervention. They will be monitored for the same outcomes as the intervention group during the 12-week study period.
Sponsors
Leads: Istanbul Health and Technology University
Collaborators: The Scientific and Technological Research Council of Turkey

This content was sourced from clinicaltrials.gov