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

NCT06876909 | Completed

• 1 other identifier: 2021PHB074-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 uric acid metabolism, and preliminarily clarify the mechanism of barley green influencing uric acid metabolism through in vitro experiments related to xanthine oxidase. This study plans to recruit patients with hyperuricemia who visit the clinical nutrition department and rheumatology and immunology department of Peking University People's Hospital, randomly dividing them into an intervention group and a control group. The intervention group will take barley green plus a balanced diet plan, while the control group will only be given a balanced diet plan. General clinical data will be collected, and nutritional measurements will be conducted. Venous blood will be drawn for the determination of uric acid metabolism-related indicators, xanthine oxidase activity, and inflammatory factor levels. The differences in uric acid and related metabolic indicators, as well as xanthine oxidase activity, between the two groups will be observed and compared to provide a scientific basis for the clinical application of barley green in non-pharmacological intervention and medical nutrition therapy for hyperuricemia.

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• uric acid levels in umol/L

  Uric acid levels were measured by blood samples at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (36)

• Xanthine oxidase activity in ng/mL

  From enrollment to the end of treatment at 12 weeks

• erythrocyte sedimentation rate in mm/h

  From enrollment to the end of treatment at 12 weeks

• antinuclear antibody in semi-quantitative

  From enrollment to the end of treatment at 12 weeks

• blood glucose in mmol/L

  From enrollment to the end of treatment at 12 weeks

• total cholesterol in mmol/L

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

control group

NO INTERVENTION

intervention group

EXPERIMENTAL

Dietary Supplement: barley green

Interventions

barley green DIETARY_SUPPLEMENT

Oral administration: 30 minutes before meals Dosage: 4 g powder, 5 g tablet Frequency: 2 times a day

intervention group

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 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Xicheng District, 100044, China

Location

Related Publications (1)

• Cui M, Shao L, Zhao S, Guo Q, Liu X, Liu P. Effects of barley green on uric acid, inflammatory factors, xanthine oxidase activity and body composition of patients with hyperuricemia: a randomized controlled trial. Front Nutr. 2025 Oct 31;12:1684829. doi: 10.3389/fnut.2025.1684829. eCollection 2025.

  PMID: 41245398 DERIVED

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 14, 2025
• Study Start: August 26, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 11, 2025

Record last verified: 2025-02

Locations

CN (1)