Clinical trial NCT06876909: Clinical Effect Observation of Barley Green Intervention in Hyperuricemia Population and Related Mechanism Study of Xanthine Oxidase
Official title: Clinical Effect Observation of Barley Green Intervention in Hyperuricemia Population and Related Mechanism Study of Xanthine Oxidase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperuricemia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: uric acid levels in umol/L
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Xanthine oxidase activity in ng/mL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: erythrocyte sedimentation rate in mm/h
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: antinuclear antibody in semi-quantitative
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: blood glucose in mmol/L
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: total cholesterol in mmol/L
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: triglycerides in mmol/L
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: high-density lipoprotein cholesterol in mmol/L
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: low-density lipoprotein cholesterol in mmol/L
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: C-reactive protein in mg/L
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: white blood cell count in 10^9/L
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: leptin level in pg/mL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: adiponectin level in ug/mL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: IL-1β in pg/mL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: IL-2 in pg/mL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: IL-4 in pg/mL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: IL-6 in pg/mL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: IL-10 in pg/mL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: IFN-γ in pg/mL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: TNF-α in pg/mL
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: height in centimeters
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: weight in kilograms
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: BMI in kg/m^2
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: body fat rate in %
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: muscle mass in kilograms
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: basal metabolic rate in kcal
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: skeletal muscle mass in kilograms
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: blood pressure in mmHg
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: waist circumference in millimeters
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: hip circumference in millimeters
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: upper arm circumference in millimeters
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: left hand grip strength in pound-force
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: right hand grip strength in pound-force
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: triceps skinfold thickness in millimeters
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: subscapular horn skinfold thickness in millimeters
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: abdominal skinfold thickness in millimeters
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: food intake dose in grams
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Xicheng District
Study officials:
References: