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

NCT07170033 | Completed

• 1 other identifier: ISTUN-GO-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief 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."

Conditions

Rheumatoid Arthritis

Keywords

Diet Therapy; Inflammation; Dietary Approaches To Stop Hypertension; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Disease Activity Score-28 (DAS-28)

  Disease activity will be assessed using the Disease Activity Score-28 (DAS-28), calculated with both C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). DAS-28 scores will be recorded at baseline, and at Weeks 4, 8, and 12. The change over time will be used to evaluate the effectiveness of the DASH diet intervention in patients with rheumatoid arthritis. According to the calculated DAS-28 score, a value of ≤3.2 indicates low disease activity; a score between \>3.2 and ≤5.1 indicates moderate disease activity; and a score \>5.1 indicates high disease activity. A DAS-28 score of \<2.6 is defined as remission.

  Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (4)

• Change in Pain Score Measured by Visual Analog Scale (VAS)

  Baseline, Week 4, Week 8, and Week 12

• Change in Biochemical Parameters

  Baseline, Week 4, Week 8, and Week 12

• Change in Scores from Health Assessment Questionnaire

  Baseline, Week 4, Week 8, and Week 12

• Change in Scores from the Short Form-36 (SF-36) Health Survey

  Baseline, Week 4, Week 8, and Week 12

Study Arms (2)

DASH Diet Group

EXPERIMENTAL

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).

Other: Dietary Approach to Stop Hypertension (DASH) Diet

Control Group

NO INTERVENTION

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.

Interventions

Dietary Approach to Stop Hypertension (DASH) Diet OTHER

"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.

DASH Diet Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Not voluntarily agreeing to participate in the study, Not being within the age range of 18-64 years, Not having a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, and not belonging to the seropositive rheumatoid arthritis subgroup, Being in remission according to the DAS-28 CRP and DAS-28 ESR disease activity scores, Having a disease duration of less than 1 year, Having previously undergone any dietary treatment specific to rheumatoid arthritis, 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 receiving glucocorticoid therapy and folic acid supplementation (10 mg weekly) recommended for patients using methotrexate, Having changes in disease-modifying anti-rheumatic drugs usage within less than 3 months, corticosteroids within less than 4 weeks, and nonsteroidal anti-inflammatory drugs within less than 10 days before starting the DASH diet treatment, having a daily oral corticosteroid dose exceeding 12.5 mg of prednisolone, Having a diagnosis of eating disorders, Being pregnant or breastfeeding, Using banned substances, Having intellectual disability, Having any allergy and/or intolerance to the foods included in the DASH diet.

Sponsors & Collaborators

• Istanbul Health and Technology University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (2)

Başakşehir Çam and Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

Location

Istanbul Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammation

Interventions

Diet

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Gökçen ÖZÜPEK

  Istanbul Health and Technology University

  PRINCIPAL INVESTIGATOR

• İkbal S ALTAY, AsstProf

  Istanbul Health and Technology University

  STUDY CHAIR

• Zeynep B KALYONCU ATASOY, AsstProf

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No masking was applied, as both participants and investigators were aware of the group assignments due to the nature of the dietary intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: This is a randomized, controlled, parallel-group trial in which participants diagnosed with seropositive rheumatoid arthritis will be assigned to either a DASH diet intervention group or a control group maintaining their habitual dietary intake. The study duration is 12 weeks.

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 12, 2025
• Study Start: May 6, 2024
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)