Status:

COMPLETED

Clinical Effect Observation of Barley Green Intervention in Hyperuricemia Population and Related Mechanism Study of Xanthine Oxidase

Lead Sponsor:

Peking University People's Hospital

Conditions:

Hyperuricemia

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

This study aims to explore the changes in metabolic-related indicators in patients with hyperuricemia under the intervention of barley green, reveal the clinical effect of barley green in regulating u...

Eligibility Criteria

Inclusion

  • Aged 18 to 65 years old; under a normal purine diet, the fasting blood uric acid level on two different days: 420 μmol/L \< blood uric acid \< 540 μmol/L (for men), 360 μmol/L \< blood uric acid \< 540 μmol/L (for women); willing to accept the assessment and sign the informed consent.

Exclusion

  • ① Patients currently receiving drug treatment for hyperuricemia;
  • Patients with diseases affecting food digestion and absorption (such as chronic diarrhea, constipation, severe digestive tract inflammation, active peptic ulcers, post-gastrointestinal resection, cholecystitis/cholecystectomy, etc.);
  • Patients with cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia (hemoglobin value below the normal reference range), mental disorders and memory impairment, epilepsy, etc.;
  • Patients simultaneously receiving other functional food nutritional support (plant active substances, health foods);
  • Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeding 3 times the upper limit of the normal value); patients with abnormal kidney function (serum creatinine exceeding the upper limit of the normal value);
  • Patients with active pulmonary tuberculosis, AIDS and other infectious diseases; ⑦ Patients with severe allergies to the ingredients of the study nutritional product;
  • Pregnant or lactating women;
  • Patients with limb disabilities and those deemed unsuitable for participation in the study by the clinical doctor (for example, patients with severe diseases not listed in the exclusion criteria); ⑩ Patients with gouty arthritis attacks ≥ 2 times; ⑪ Patients with one gouty arthritis attack and blood uric acid \> 480 μmol/L, or combined with any of the following: age \< 40 years old, evidence of tophi or urate deposition in the joint cavity, uric acid nephrolithiasis or renal function impairment (eGFR ≤ 89 ml/(min·1.73 m²)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia (any of the four lipid indicators exceeding the normal reference range), obesity (BMI ≥ 28 kg/m²), coronary heart disease, stroke, heart failure; ⑫ Patients with blood uric acid \> 480 μmol/L and combined with any of the following: uric acid nephrolithiasis or renal function impairment (eGFR ≤ 89 ml/(min·1.73 m²)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia (any of the four lipid indicators exceeding the normal reference range), obesity (BMI ≥ 28 kg/m²), coronary heart disease, stroke, heart failure.

Key Trial Info

Start Date :

August 26 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2024

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT06876909

Start Date

August 26 2021

End Date

June 30 2024

Last Update

August 11 2025

Active Locations (1)

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Peking University People's Hospital

Beijing, Xicheng District, China, 100044