NCT07170033

The Effect of the DASH Diet on Treatment Outcomes in Adults Diagnosed With Rheumatoid Arthritis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Istanbul Health and Technology University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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."

Detailed description

Prior to the commencement of the study, participants will be informed about the research, and those who voluntarily agree to participate will be asked to sign an informed consent form. This study, designed to determine the effect of the DASH diet on treatment outcomes in patients diagnosed with seropositive rheumatoid arthritis (RA), will collect data through a questionnaire including participants' demographic characteristics (gender, age, marital status, education level, occupation, income status), health status (duration of treatment, RA symptoms, presence of RA in relatives, use of medications and nutritional supplements, history of any RA-specific nutritional or diet therapy, presence of any chronic diseases other than RA, pregnancy/lactation status in RA patients), dietary habits (number of main and snack meals, reasons for meal skipping, foods consumed during snacks, average daily water intake, smoking and alcohol consumption), functional status in daily life, quality of life, food consumption frequency, and a 3-day dietary record. Additionally, numerical data including patients' 24-hour physical activity level, DAS-28 disease activity score, VAS general health assessment, VAS pain score, anthropometric measurements (body weight, height, and BMI), and basal metabolic rate (BMR) will be obtained.The DASH diet prescribed to patients in the intervention group will be planned according to their 24-hour physical activity level and BMR. The DASH diet adherence score will be calculated using the "Nutrition Information System (BeBiS)" program, based on the patients' dietary intake records including average daily intake of total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium, and potassium. Biochemical findings of the patients will be obtained from the patient information system with physician approval.This randomized controlled trial is planned to implement the DASH diet intervention for 3 months (12 weeks), considering similar studies in the literature, to observe the expected differences in patients with seropositive rheumatoid arthritis in the intervention group. Patients in the control group will continue their usual diet without any specific dietary intervention. Relevant data from individuals in both the intervention and control groups will be collected again at the end of weeks 4, 8, and 12 following the dietary intervention.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
OTHER	Dietary Approach to Stop Hypertension (DASH) Diet	"Dietary intervention: DASH diet" Participants in the intervention group will follow the Dietary Approaches to Stop Hypertension (DASH) diet for 12 weeks. The diet plan will be personalized based on each participant's 24-hour physical activity level and basal metabolic rate. Dietary adherence will be monitored through 3-day dietary intake records and DASH diet scores calculated using the Nutrition Information System (BeBiS). The intervention aims to assess the effect of the DASH diet on inflammatory markers, disease activity scores, functional status, and quality of life in adults diagnosed with seropositive rheumatoid arthritis.

Timeline

• Start date: 2024-05-06
• Primary completion: 2025-10-06
• Completion: 2025-10-06
• First posted: 2025-09-12
• Last updated: 2026-03-27

Locations

2 sites across 1 country: Turkey (Türkiye)