Evaluation of the Impact of Dietary Education and Intervention on Gout Patients Receiving Urate-Lowering Therapy

NCT07834840 | Enrolling By Invitation

• 1 other identifier: AJOUIRB-IV-2025-145
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to learn whether dietary education and intervention can reduce blood uric acid levels in patients with gout. The main questions this study aims to answer are:

• Can dietary education and intervention reduce gout-related clinical laboratory results?
• Can dietary education and intervention improve BMI and SBP/DBP in participants with gout? In this study, participants will be divided into three groups, including a control group, and their outcomes compared, in order to determine whether a low-purine (low-uric-acid) diet and a DASH diet are effective in reducing blood uric acid levels in participants with gout. Participants will:
• Participate in the study for a total of 2 years, receiving dietary education and intervention according to their assigned group throughout this period
• Complete surveys, physical measurements, and receive dietary education once every 6 months
• Receive dietary education by phone and through an app, and complete surveys, once every month

Conditions

Gout Disease; Gout

Keywords

Gout; DASH; Gout in Diet; low purine diet

Outcome Measures

Primary Outcomes (1)

• Uric Acid Level

  Measured in serum

  Baseline, At 12-months, At 24-months

Secondary Outcomes (4)

• Body Mass Index (kg/m^2)

  Baseline, At 6-months, At 12-months, At 18-months, At 24-months

• Systolic Blood Pressure(mmHg)

  Baseline, At 6-months, At 12-months, At 18-months, At 24-months

• Diastolic Blood Pressure (mmHg)

  Baseline, At 6-months, At 12-months, At 18-months, At 24-months

• Change in Purine-rich food Intake

  Baseline, At 6-months, At 12-months, At 18-months, At 24-months

Study Arms (3)

Usual Diet and lifestyle

NO INTERVENTION

Participants will maintain their usual diet and lifestyle without receiving a specific dietary intervention.

Low-Uric acid Diet

EXPERIMENTAL

The low-uric-acid diet is designed to provide a higher daily purine intake than a low-purine diet. Participants will receive dietary education to limit the consumption of red meat, organ meats, seafood, and alcohol, while emphasizing plant-based foods such as vegetables, fruits, whole grains, and legumes.

Behavioral: Low-Uric acid Diet

DASH Diet

EXPERIMENTAL

\*\*DASH Diet:\*\* Participants will be encouraged to consume lean meats, selected fish, vegetables, fruits, whole grains, low-fat dairy products, nuts, and legumes. They will also be asked to limit their intake of sodium, saturated fat, refined carbohydrates, and fatty meats.

Behavioral: DASH Diet

Interventions

DASH Diet BEHAVIORAL

Participants will receive monthly reminders about dietary education and complete questionnaires to assess adherence to the assigned diet. * Every 6 months, participants will undergo measurements of body composition using bioelectrical impedance analysis, waist and hip circumference, and blood pressure during their scheduled outpatient visits to assess their health status. * Blood samples will be collected annually to assess the effects of the dietary intervention and education on participants' health. * Participants will receive KRW 40,000 in compensation for study participation every 12 months.

DASH Diet

Low-Uric acid Diet BEHAVIORAL

Participants will receive monthly reminders about dietary education and complete questionnaires to assess adherence to the assigned diet. * Every 6 months, participants will undergo measurements of body composition using bioelectrical impedance analysis, waist and hip circumference, and blood pressure during their scheduled outpatient visits to assess their health status. * Blood samples will be collected annually to assess the effects of the dietary intervention and education on participants' health. * Participants will receive KRW 40,000 in compensation for study participation every 12 months.

Low-Uric acid Diet

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently receiving urate-lowering therapy at this hospital
• Male, aged 19 years or older, with a history of at least one gout flare

You may not qualify if:

• Unwilling or unable to provide informed consent
• Life expectancy of less than 2years due to comorbid conditions
• Refusal of urate-lowering therapy
• Estimated glomerular filtration rate (eGFR) of 45 mL/min/1.73m² or less (diagnosed with chronic kidney disease stage 3B or higher)
• E. Diagnosis of chronic obstructive pulmonary disease (COPD) or asthma within the past 6 months
• F. History of gastrointestinal disease (including inflammatory bowel disease, malabsorption, gastric bypass surgery, or major bowel resection)
• G. Currently receiving chemotherapy for cancer treatment
• H. Diagnosis of myocardial infarction, heart failure, or angina, or history of coronary artery bypass surgery or angioplasty, within the past 6 months
• I. Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study

Sponsors & Collaborators

• Sung Keon Cho: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Related Publications (2)

• Yokose C, McCormick N, Choi HK. The role of diet in hyperuricemia and gout. Curr Opin Rheumatol. 2021 Mar 1;33(2):135-144. doi: 10.1097/BOR.0000000000000779.

  PMID: 33399399 RESULT

• Yokose C, McCormick N, Rai SK, Lu N, Curhan G, Schwarzfuchs D, Shai I, Choi HK. Effects of Low-Fat, Mediterranean, or Low-Carbohydrate Weight Loss Diets on Serum Urate and Cardiometabolic Risk Factors: A Secondary Analysis of the Dietary Intervention Randomized Controlled Trial (DIRECT). Diabetes Care. 2020 Nov;43(11):2812-2820. doi: 10.2337/dc20-1002. Epub 2020 Sep 2.

  PMID: 33082244 RESULT

MeSH Terms

Conditions

Gout

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to one of three groups: the control group, the low-urate diet group, or the DASH diet group. Participants will receive diet education according to their assigned group and undergo the corresponding dietary intervention throughout the study period.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 22, 2026
• Study Start: March 26, 2025
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): May 1, 2035
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

KR (1)