Evaluation of the Impact of Dietary Education and Intervention on Gout Patients Receiving Urate-Lowering Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Uric Acid Level
研究概览
简要总结
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
详细描述
Gout is becoming more common in Korea. The number of people treated for gout grew from about 220,000 in 2010 to about 300,000 in 2014. This is an average increase of about 8.5% each year. Hyperuricemia is considered the direct cause of gout. Hyperuricemia also appears to be becoming more common. Its average rate rose from 23.9% in 2021 to 26.7% in 2024. Young men appear to be affected the most. Men in their 20s had a rate of 43.8%. Men in their 30s had a rate of 45.7%. These are the highest rates of any age group. This suggests that hyperuricemia is rising fastest among young men. It also suggests that habits such as drinking alcohol and poor diet may need to improve.
Hyperuricemia and gout are known to raise the risk of several chronic diseases. These include high blood pressure, diabetes, and kidney disease. Chronic diseases need ongoing treatment and management. Diets have been developed to help manage symptoms in several conditions, such as diabetes, hyperkalemia, and high blood pressure. However, diets designed specifically for gout patients appear to be limited. So far, the low-purine diet is the only diet known to directly affect blood uric acid levels. However, the low-purine diet can be hard to follow within a typical Korean diet. It also appears to have low long-term sustainability. For this reason, this study modified the low-purine diet into a version that is easier to follow in daily life. This modified diet is called the low-uric acid diet.
The standard low-purine diet usually limits purine intake to 150 mg or less per day. It limits protein from meat, fish, and tofu, and it also limits fat intake. In contrast, the low-uric acid diet used in this study sets purine intake between 300 mg and 400 mg per day. This diet also includes the following recommendations. Participants are encouraged to drink at least 1.5 liters of water per day. Participants are encouraged to have one serving of low-fat dairy per day. Participants are encouraged to eat poultry and fish instead of red meat and organ meats. Among fish, participants are encouraged to choose white fish over oily fish. Participants are encouraged to eat vegetables and fruit at least once per day, and to eat berries regularly. Participants are encouraged to choose plant protein over animal protein. Participants are encouraged to eat whole grains or mixed grains instead of refined white rice. Participants are asked to limit drinks with high-fructose corn syrup or added fructose. Participants are also asked to strictly limit alcohol.
Inclusion Criteria
- Currently receiving urate-lowering therapy at this hospital
- Male, aged 19 years or older, with a history of at least one gout flare
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Currently receiving urate-lowering therapy at this hospital
- •Male, aged 19 years or older, with a history of at least one gout flare
排除标准
- •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
研究组 & 干预措施
Usual Diet and lifestyle
Participants will maintain their usual diet and lifestyle without receiving a specific dietary intervention.
Low-Uric acid Diet
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.
干预措施: Low-Uric acid Diet (Behavioral)
DASH Diet
**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.
干预措施: DASH Diet (Behavioral)
结局指标
主要结局
Uric Acid Level
时间窗: Baseline, At 12-months, At 24-months
Measured in serum
次要结局
- 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)
研究者
Sung Keon Cho
Associate Professor
Ajou University School of Medicine