The goal of this clinical trial is to learn whether tart cherry citrate effervescent tablets can lower uric acid levels in people with asymptomatic hyperuricemia (high uric acid levels without gout symptoms).
The main question it aims to answer is:
Does taking tart cherry citrate effervescent tablets lower uric acid levels more effectively than taking a placebo (inactive) tablet, when both groups also receive lifestyle guidance?
Researchers will compare two groups of participants. Both groups will receive lifestyle guidance (advice on diet and exercise). In addition:
* One group will take the tart cherry citrate effervescent tablets. * The other group will take a placebo effervescent tablet (looks and tastes the same but contains no active ingredient).
The study will last 24 weeks.
Participants will:
* Take the assigned effervescent tablet twice daily for 24 weeks * Follow lifestyle guidance for diet and exercise * Attend scheduled clinic visits for checkups and tests * Provide blood and urine samples for testing
Aged 18 to 65 years, regardless of sex;
Meet the diagnostic criteria for primary hyperuricemia, with serum urate levels between 420 μmol/L and 540 μmol/L (for those without comorbidities) or between 420 μmol/L and 480 μmol/L (for those with at least one of the following comorbidities: hypertension, dyslipidemia, diabetes mellitus, obesity, stroke, coronary heart disease, heart failure, or CKD stage ≥2);
Participants with asymptomatic hyperuricemia who have not previously received urate-lowering therapy and have no history of acute gout flares;
Voluntarily participate in the study and provide written informed consent.
Known allergy to any of the study medications, food products, or their components; current allergies; or known hypersensitivity;
Active liver disease or cirrhosis, or liver dysfunction with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2 times the upper limit of normal (ULN);
Acute infection or active gastrointestinal ulcers;
History of thyroid dysfunction;
Parallel
tart cherry citrate effervescent table
Dietary supplementEach effervescent tablet contains tart cherry extract and citrate. Participants take 4.0 g (one tablet) dissolved in 200-250 mL of water twice daily (morning and evening), regardless of meals. Daily total water intake is controlled at 2000-2500 mL. The tablet is taken as an adjunct to lifestyle guidance.
Placebo Control Group
Dietary supplementMatching placebo effervescent tablet identical in appearance, taste, and preparation to the tart cherry citrate effervescent tablet but containing no active ingredients. Participants take 4.0 g (one tablet) dissolved in 200-250 mL of water twice daily (morning and evening), regardless of meals. Daily total water intake is controlled at 2000-2500 mL. The tablet is taken as an adjunct to lifestyle guidance.
Difference in serum urate (sUA) levels between groups at week 24
Serum uric acid measured in μmol/L from fasting blood sample.
Difference in serum urate (sUA) levels between groups at each visit
Changes in serum urate (sUA) levels within the experimental group before and after intervention
Within-group change in sUA from enrollment to end of treatment.
Difference in morning urine pH between groups at week 24
Differences in urine pH (morning urine) between groups at each visit
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