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HyperuricemiaNCT06876909

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

A study testing barley green in people with Hyperuricemia, run by Peking University People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hyperuricemia
What is being tested?
barley green
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
26 Aug 2021to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University People's Hospital

    Beijing, Xicheng District, 100044

Other trials in China

About this study

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
Being tested
barley green
Medical subject headings
Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • barley greenDietary supplement

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

Study groups in NCT06876909
Study groupRoleWhat they receive
control groupNo interventionNot described
intervention groupExperimentalNot described
Receives: Dietary Supplement: barley green

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (36)
  1. Xanthine oxidase activity in ng/mL

    Xanthine oxidase activity was 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  2. erythrocyte sedimentation rate in mm/h

    Erythrocyte sedimentation rates 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  3. antinuclear antibody in semi-quantitative

    Antinuclear antibodies 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  4. blood glucose in mmol/L

    Blood glucoses 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  5. total cholesterol in mmol/L

    Total cholesterols 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  6. triglycerides in mmol/L

    Triglycerides 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  7. high-density lipoprotein cholesterol in mmol/L

    High-density lipoprotein cholesterols 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  8. low-density lipoprotein cholesterol in mmol/L

    Low-density lipoprotein cholesterols 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  9. C-reactive protein in mg/L

    C-reactive proteins 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  10. white blood cell count in 10^9/L

    White blood cell counts 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  11. leptin level in pg/mL

    Leptin 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  12. adiponectin level in ug/mL

    Adiponectin 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  13. IL-1β in pg/mL

    IL-1β 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  14. IL-2 in pg/mL

    IL-2 levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  15. IL-4 in pg/mL

    IL-4 levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  16. IL-6 in pg/mL

    IL-6 levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  17. IL-10 in pg/mL

    IL-10 levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  18. IFN-γ in pg/mL

    IFN-γ levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  19. TNF-α in pg/mL

    TNF-α levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  20. height in centimeters

    Height in centimeters were measured by Manual Height Ruler at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  21. weight in kilograms

    Weight in kilograms were measured by the Inbody 770 instrument at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  22. BMI in kg/m^2

    Weight and height will be combined to report BMI in kg/m^2 at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  23. body fat rate in %

    Body fat rates were measured by the Inbody 770 instrument at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  24. muscle mass in kilograms

    Muscle masses were measured by were measured by the Inbody 770 instrument at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  25. basal metabolic rate in kcal

    Basal metabolic rates were measured by the Inbody 770 instrument at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  26. skeletal muscle mass in kilograms

    Skeletal muscle masses were measured by the Inbody 770 instrument at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  27. blood pressure in mmHg

    Blood pressures were measured by electronic blood pressure monitor at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  28. waist circumference in millimeters

    Waist circumferences were measured by tape measure at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  29. hip circumference in millimeters

    Hip circumferences were measured by tape measure at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  30. upper arm circumference in millimeters

    Upper arm circumferences were measured by tape measure at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  31. left hand grip strength in pound-force

    Left hand grip strengths were measured by grip dynamometer at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  32. right hand grip strength in pound-force

    Right hand grip strengths were measured by grip dynamometer at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  33. triceps skinfold thickness in millimeters

    Triceps skinfold thicknesses were measured by skin fold thickness gauge at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  34. subscapular horn skinfold thickness in millimeters

    Subscapular horn skinfold thicknesses were measured by skin fold thickness gauge at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  35. abdominal skinfold thickness in millimeters

    Abdominal skinfold thicknesses were measured by skin fold thickness gauge at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

  36. food intake dose in grams

    Data of food intake doses were taken by food frequency questionnaire and 3-day food diary at four time points: the day of enrollment, 4 weeks after enrollment, 8 weeks after enrollment and 12 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start26 Aug 2021
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06876909
Sponsor's protocol ID
2021PHB074-001
Status last verified
Feb 2025
First submitted
25 Feb 2025
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 41245398

Questions about this trial

What is this clinical trial studying?

A study testing barley green in people with Hyperuricemia, run by Peking University People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

uric acid levels in umol/L (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06876909, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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