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Completed

NCT Number: NCT07170033

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

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."

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Disease Activity Score-28 (DAS-28)

    Time frame: Baseline, Week 4, Week 8, and Week 12

    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.

Secondary outcomes

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

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Pain intensity will be assessed using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst possible pain). The change in VAS pain scores will be recorded at baseline, Week 4, Week 8, and Week 12 to evaluate the effect of the DASH diet intervention on pain levels in patients with rheumatoid arthritis. Pain intensity is classified as mild for scores <3; moderate for scores between 3 and 6; and severe for scores >6.

  2. Change in Biochemical Parameters

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Changes in biochemical parameters (such as inflammatory markers including CRP and ESR) will be monitored at baseline, Week 4, Week 8, and Week 12 to evaluate the biochemical response to the DASH diet intervention in patients with rheumatoid arthritis.

  3. Change in Scores from Health Assessment Questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Scores obtained from the Health Assessment Questionnaire (HAQ) will be recorded at baseline, Week 4, Week 8, and Week 12 to assess changes in patients' functional status and overall health following the DASH diet intervention. The scale score ranges from 0 to 3, with higher scores indicating poorer health status.

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

    Time frame: Baseline, Week 4, Week 8, and Week 12

    Scores obtained from the Short Form-36 (SF-36) Health Survey will be recorded at baseline, Week 4, Week 8, and Week 12 in patients with rheumatoid arthritis to evaluate changes in quality of life. An increase in the scores on the scale indicates an improvement in health-related quality of life.

Sponsors and collaborators

Lead sponsor

Istanbul Health and Technology University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 12, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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