An interventional study of DASH Diet and Low-Uric acid Diet in Gout Disease and Gout, sponsored by Sung Keon Cho. Enrolling by invitation at 1 site in South Korea. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Sung Keon Cho · Not applicable, Interventional, and Treatment
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:
Participants will:
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
Exclusion Criteria
The primary endpoints of this study are as follows:
The secondary endpoints are as follows:
Primary and secondary endpoints will be measured every 6 months from baseline. Follow-up visits will use a 3-month window, based on participant scheduling needs.
The Dietary Compliance Questionnaire and the Medication Adherence Report Scale (MARS-5) will be administered continuously throughout the study period for Groups B and C. The REAP-S questionnaire will also be used to assess the objectivity of these measures. FEUA (fractional excretion of uric acid) will be measured once during the study period.
This study includes a total of 4 repeated measurements over 2 years. Comparisons will include within-person comparisons, in which the same participant's data are compared over time (for example, A0001 at screening versus A0001 at 24 months). Comparisons will also include between-group comparisons of mean values.
As an exception, analyses will be conducted both including and excluding participants weighing more than 100 kg. Use of weight-loss injections or oral medications, such as Saxenda, Wegovy, and Mounjaro, will also be collected as a variable. An additional sensitivity analysis will be conducted based on this variable.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 300 is above the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →This is the only study on the registry with Sung Keon Cho as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will maintain their usual diet and lifestyle without receiving a specific dietary intervention.
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:\*\* 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
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.
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.
Uric Acid Level
Measured in serum
Time frame: Baseline, At 12-months, At 24-months
Body Mass Index (kg/m^2)
Measured using a home-use InBody device.
Time frame: Baseline, At 6-months, At 12-months, At 18-months, At 24-months
Systolic Blood Pressure(mmHg)
Time frame: Baseline, At 6-months, At 12-months, At 18-months, At 24-months
Diastolic Blood Pressure (mmHg)
Time frame: Baseline, At 6-months, At 12-months, At 18-months, At 24-months
Change in Purine-rich food Intake
Change in purine-rich food intake from baseline at each follow-up assessment.
Time frame: Baseline, At 6-months, At 12-months, At 18-months, At 24-months
Plan to share: Undecided
Started Mar 2025 (actual). Primary completion is estimated for Jan 2035, 118 months after the start.
Of 34 non-industry interventional studies with no phase under Gout, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 118 months is above that.
Counting every sponsor, half of 35 studies reached it within 29 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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