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RecruitingNCT07613138TaCCi-HUAUpdated Jun 17, 2026

Tart Cherry Citrate Effervescent Tablet for Urate-Lowering Therapy in Participants With Asymptomatic Hyperuricemia

An interventional study of tart cherry citrate effervescent table and Placebo Control Group in Hyperuricemia With or Without Gout, sponsored by Beijing Zhecheng Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by Beijing Zhecheng Biotechnology Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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
Read the detailed description

Background and Rationale Hyperuricemia, a common metabolic disorder characterized by elevated serum urate due to purine metabolism dysfunction, affects 14.0% of Chinese adults (24.5% in men, 3.6% in women). Elevated serum urate leads to crystal deposition in joints, soft tissues, and kidneys, contributing not only to gout flares but also to renal and other organ damage. Although urate-lowering therapies (e.g., febuxostat, benzbromarone) effectively control serum urate, current guidelines do not recommend early pharmacological intervention for asymptomatic hyperuricemia due to safety concerns. Thus, additional strategies beyond lifestyle guidance are needed for this population.

Prior Research A prospective randomized study by the Affiliated Hospital of Qingdao University in 182 gout patients showed that a citrate mixture had comparable urate-lowering and urine alkalinization effects to sodium bicarbonate. After 3 months, the citrate effervescent tablet was superior in reducing hematuria and gout recurrence. Tart cherries, rich in anti-inflammatory and antioxidant anthocyanins, have been shown overseas to improve cardiovascular risk factors (blood pressure, cholesterol, blood glucose). The tart cherry citrate effervescent tablet enhances the original citrate mixture with increased citric acid and added tart cherry components.

A 24-week randomized, open-label, parallel-controlled trial in 282 male gout patients (fasting urine pH ≤6) demonstrated that the tart cherry citrate effervescent tablet had similar efficacy and safety to citrate mixture and sodium bicarbonate for urine alkalinization and serum urate lowering. However, it produced greater improvements in urinary albumin-to-creatinine ratio (UACR) and C-reactive protein (CRP), significantly reduced gout flare frequency, and improved metabolic parameters (systolic/diastolic blood pressure, fasting glucose, homeostasis model assessment-insulin resistance [HOMA-IR], total cholesterol).

Study Objectives To evaluate the efficacy and safety of tart cherry citrate effervescent tablet in participants with asymptomatic hyperuricemia.

Trial Design

  • Design: Randomized, placebo-controlled, parallel-group trial.
  • Number of participants: 196 (1:1 randomization).
  • Randomization method: Block randomization.
  • Sample size calculation: Based on a pilot study of tart cherry citrate mixture (mean serum urate changes: 54±65 μmol/L in active group vs. 30±19 μmol/L in lifestyle guidance group), 65 participants per group provided >80% power at α=0.05 to detect the difference. Accounting for a 20-25% dropout rate over 12 weeks and extending observation to 24 weeks, the sample size was increased by 50%, resulting in 196 total participants.
  • Study population: Participants with primary asymptomatic hyperuricemia who voluntarily sign informed consent and meet eligibility criteria.

Treatment Regimen

  • Experimental group: Lifestyle guidance + tart cherry citrate effervescent tablet 4.0 g twice daily (bid)
  • Placebo control group: Lifestyle guidance + matching placebo effervescent tablet
  • Daily water intake: 2000-2500 mL. Two effervescent tablets taken morning and evening (with or without meals).
  • Lifestyle guidance: face-to-face and WeChat group-based regular dietary advice, exercise guidance, and education on recognizing gout flares.

Details are provided in the study protocol.

Study Duration 24 weeks.

Outcome Measures

Efficacy outcomes:

  • Serum uric acid (sUA) at 12 and 24 weeks
  • Morning urine pH
  • 24-hour urinary uric acid excretion (UUE)
  • New-onset gout flares
  • Changes in kidney stones
  • Urate crystal volume by dual-energy computed tomography (DECT)
  • C-reactive protein (CRP)
  • Renal function (estimated glomerular filtration rate [eGFR], urinary albumin-to--creatinine ratio [UACR])
  • Metabolic syndrome components (fasting blood glucose [FBG], blood pressure, lipid profile)

Safety outcomes:

  • Vital signs
  • Adverse events (AEs)
  • Safety laboratory parameters (routine blood/urine tests, liver/renal function, -electrolytes)

Efficacy Evaluation

Primary outcome:

-Difference in serum urate (sUA) levels between groups at week 24.

Secondary outcomes:

  • Differences in sUA at week 12 and week 24
  • Change in sUA within experimental group from baseline to week 24
  • Differences in morning urine pH at week 12 and week 24
  • Changes in urine components (hematuria, UACR, urine crystals) from baseline to week 24
  • Changes in 24-hour UUE from baseline to week 24
  • Differences in eGFR and UACR between groups at week 12 and week 24
  • Changes in eGFR and UACR within groups from baseline to week 24
  • Changes in metabolic outcomes (FBG, blood pressure, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, HOMA-IR) between groups at week 12 and week 24
  • Changes in metabolic outcomes within experimental group from baseline to week 24
  • Number of participants with new-onset gout flares during the 24-week treatment period
  • Changes in kidney stone size (mm) within groups from baseline to week 24

Safety Evaluation Monitoring of vital signs at each visit Clinically significant changes in safety laboratory parameters Documentation and assessment of all adverse events

Conclusion This randomized, placebo-controlled trial will compare the effects of tart cherry citrate effervescent tablet versus placebo plus lifestyle guidance on serum urate reduction in participants with asymptomatic hyperuricemia. The findings will provide new clinical data to support early intervention strategies for this condition.

02

Conditions studied

  • Hyperuricemia With or Without Gout

Browse trials for

Keywords

  • hyperuricemia
  • uric acid
  • tart cherry
  • citrate
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18 to 65 years, regardless of sex;
  2. 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);
  3. Participants with asymptomatic hyperuricemia who have not previously received urate-lowering therapy and have no history of acute gout flares;
  4. Voluntarily participate in the study and provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Known allergy to any of the study medications, food products, or their components; current allergies; or known hypersensitivity;
  2. 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);
  3. Acute infection or active gastrointestinal ulcers;
  4. History of thyroid dysfunction;
  5. Estimated glomerular filtration rate (eGFR) \<60 mL/min;
  6. Severe cardiac diseases, such as decompensated heart failure (NYHA class III or IV), unstable angina, or a history of myocardial infarction within the previous 12 months;
  7. Renal cysts, medullary sponge kidney, or other obstructive nephropathies;
  8. Rheumatoid arthritis requiring treatment or arthropathies due to other causes;
  9. Current use of medications that affect urate levels, including febuxostat, allopurinol, benzbromarone, probenecid, azathioprine, 6-mercaptopurine, cyclosporine, cyclophosphamide, pyrazinamide, sulfamethoxazole, trimethoprim, theophylline, thiazide diuretics, aspirin (>325 mg/day) or other salicylates, losartan, or intravenous colchicine;
  10. Secondary hyperuricemia due to hematologic disorders, renal diseases, or radiotherapy/chemotherapy for malignancies;
  11. Brain disorders with impaired judgment, or mental disorders that preclude cooperation;
  12. Alcohol or substance abuse;
  13. Participation in another clinical trial within the three months prior to screening;
  14. Malignancy or active tuberculosis;
  15. Presence of other concurrent conditions that, in the investigator's judgment, may affect the efficacy evaluation or result in poor compliance;
  16. Use of glucocorticoids;
  17. Any other reason that, in the investigator's judgment, makes the participant unsuitable for enrollment in this trial.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
196 participants (estimated)

Study arms

  • Experimental
    Tart Cherry Citrate Effervescent Tablet

    Lifestyle guidance + tart cherry citrate effervescent tablet 4.0 g twice daily

    Dietary Supplement: tart cherry citrate effervescent table

  • Placebo comparator
    Placebo Effervescent Tablet

    Matching 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.

    Dietary Supplement: Placebo Control Group

Interventions

  • Dietary supplementtart cherry citrate effervescent table

    Each 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.

  • Dietary supplementPlacebo Control Group

    Matching 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.

05

What researchers measure

Primary outcomes

  1. Difference in serum urate (sUA) levels between groups at week 24

    Serum uric acid measured in μmol/L from fasting blood sample.

    Time frame: At week 24

Secondary outcomes

  1. Difference in serum urate (sUA) levels between groups at each visit

    Time frame: At week 12 and week 24

  2. 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.

    Time frame: Baseline to Week 24

  3. Difference in morning urine pH between groups at week 24

    Time frame: At week 24

  4. Differences in urine pH (morning urine) between groups at each visit

    Time frame: At baseline, week 12, and week 24

  5. Changes in 24-hour urinary uric acid excretion (UUE) within groups before and after intervention

    Time frame: At baseline and week 24

  6. Difference in estimated Glomerular Filtration Rate (eGFR) between groups at week 24

    Time frame: At week 24

  7. Change from baseline in eGFR at each visit

    Time frame: At baseline, week 12, and week 24

  8. Change from baseline in eGFR within the experimental group at week 24

    Time frame: At baseline and week 24

  9. Change from baseline in fasting blood glucose (FBG) between groups at week 12 and week 24

    Time frame: At baseline, week 12, and the final visit

  10. Change from baseline in systolic blood pressure (SBP) between groups at week 12 and week 24

    Time frame: Baseline, week 12, week 24

  11. Change from baseline in diastolic blood pressure (DBP) between groups at week 12 and week 24

    Time frame: Baseline, week 12, week 24

  12. Change from Baseline in Serum Total Cholesterol Concentration between Groups at Week 12 and Week 24

    Time frame: Baseline, week 12, week 24

  13. Change from Baseline in Serum Triglyceride Concentration between Groups at Week 12 and Week 24

    Time frame: Baseline, week 12, week 24

  14. Change from Baseline in Serum HDL Cholesterol Concentration between Groups at Week 12 and Week 24

    Time frame: Baseline, week 12, week 24

  15. Change from Baseline in Serum LDL Cholesterol Concentration between Groups at Week 12 and Week 24

    Time frame: Baseline, week 12, week 24

  16. Change from Baseline in Fasting Blood Glucose Concentration in the Experimental Group at Week 24

    Time frame: At baseline and week 24

  17. Change from baseline in systolic blood pressure (SBP) within the experimental group at week 24

    Time frame: At baseline and week 24

  18. Change from baseline in diastolic blood pressure (DBP) within the experimental group at week 24

    Time frame: At baseline and week 24

  19. Change from Baseline in Serum Total Cholesterol Concentration in the Experimental Group at Week 24

    Time frame: At baseline and week 24

  20. Change from Baseline in Serum Triglyceride Concentration in the Experimental Group at Week 24

    Time frame: At baseline and week 24

  21. Change from Baseline in Serum HDL Cholesterol Concentration in the Experimental Group at Week 24

    Time frame: At baseline and week 24

  22. Change from Baseline in Serum LDL Cholesterol Concentration in the Experimental Group at Week 24

    Time frame: At baseline and week 24

  23. Number of participants with new-onset gout flares

    Time frame: From baseline to week 24

  24. Number of participants with new-onset kidney stones

    Time frame: From baseline to week 24

  25. Change from baseline in kidney stone size (mm) within the experimental group

    Time frame: Baseline and week 24

  26. Changes in urate crystal volume (mm³) within groups before and after intervention

    Time frame: Baseline and week 24

06

Study locations

1 of 1 sites recruiting
  • Xiamen University Affiliated Xiang'an Hospital
    Xiamen, Fujian, China
    • Mingshu Sun, PhD · Principal investigator
    Recruiting
07

References and documents

Publications

  • Xue X, Liu Z, Li X, Lu J, Wang C, Wang X, Ren W, Sun R, Jia Z, Ji X, Chen Y, He Y, Ji A, Sun W, Zhang H, Merriman TR, Li C, Cui L. The efficacy and safety of citrate mixture vs sodium bicarbonate on urine alkalization in Chinese primary gout patients with benzbromarone: a prospective, randomized controlled study. Rheumatology (Oxford). 2021 Jun 18;60(6):2661-2671. doi: 10.1093/rheumatology/keaa668. PubMed 33211886 ↗
  • Wang C, Sun W, Dalbeth N, Wang Z, Wang X, Ji X, Xue X, Han L, Cui L, Li X, Liu Z, Ji A, He Y, Sun M, Li C. Efficacy and safety of tart cherry supplementary citrate mixture on gout patients: a prospective, randomized, controlled study. Arthritis Res Ther. 2023 Sep 7;25(1):164. doi: 10.1186/s13075-023-03152-1. PubMed 37679816 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared because the informed consent form did not include provisions for data sharing beyond the primary study objectives, and the sponsor does not have an established data sharing platform.

08

Registry details

Key details

Study ID
NCT07613138
Lead sponsor
Beijing Zhecheng Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
May 29, 2026
Start date
Jun 4, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Jun 17, 2026

Study contacts

Rui Wang, PhD
Contact
wangrui@zcbiometech.com
86 010 64935208

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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