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

NCT07613138 | Recruiting

• 1 other identifier: BJZhecheng-TaCCi-HUA-2026
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hyperuricemia With or Without Gout

Keywords

hyperuricemia; uric acid; tart cherry; citrate

Outcome Measures

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.

  At week 24

Secondary Outcomes (26)

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

  At week 12 and week 24

• Changes in serum urate (sUA) levels within the experimental group before and after intervention

  Baseline to Week 24

• Difference in morning urine pH between groups at week 24

  At week 24

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

  At baseline, week 12, and week 24

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

  At baseline and week 24

Study Arms (2)

Tart Cherry Citrate Effervescent Tablet

EXPERIMENTAL

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

Dietary Supplement: tart cherry citrate effervescent table

Placebo Effervescent Tablet

PLACEBO COMPARATOR

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

Placebo Control Group DIETARY_SUPPLEMENT

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.

Placebo Effervescent Tablet

tart cherry citrate effervescent table DIETARY_SUPPLEMENT

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.

Tart Cherry Citrate Effervescent Tablet

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Estimated glomerular filtration rate (eGFR) \<60 mL/min;
• 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;
• Renal cysts, medullary sponge kidney, or other obstructive nephropathies;
• Rheumatoid arthritis requiring treatment or arthropathies due to other causes;
• 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;
• Secondary hyperuricemia due to hematologic disorders, renal diseases, or radiotherapy/chemotherapy for malignancies;
• Brain disorders with impaired judgment, or mental disorders that preclude cooperation;
• Alcohol or substance abuse;
• Participation in another clinical trial within the three months prior to screening;
• Malignancy or active tuberculosis;
• Presence of other concurrent conditions that, in the investigator's judgment, may affect the efficacy evaluation or result in poor compliance;

Sponsors & Collaborators

• Beijing Zhecheng Biotechnology Co., Ltd.: lead

Study Sites (1)

Xiamen University Affiliated Xiang'an Hospital

Xiamen, Fujian, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 33211886 RESULT

• 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.

  PMID: 37679816 RESULT

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rui Wang, PhD

CONTACT

86 010 64935208; wangrui@zcbiometech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 29, 2026
• Study Start: June 4, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)