Clinical Effect Observation of Barley Green Intervention in Hyperuricemia Population and Related Mechanism Study of Xanthine Oxidase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- uric acid levels in umol/L
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
uric acid levels in umol/L
时间窗: From enrollment to the end of treatment at 12 weeks
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.
次要结局
- 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)
- triglycerides in mmol/L(From enrollment to the end of treatment at 12 weeks)
- high-density lipoprotein cholesterol in mmol/L(From enrollment to the end of treatment at 12 weeks)
- low-density lipoprotein cholesterol in mmol/L(From enrollment to the end of treatment at 12 weeks)
- C-reactive protein in mg/L(From enrollment to the end of treatment at 12 weeks)
- white blood cell count in 10^9/L(From enrollment to the end of treatment at 12 weeks)
- leptin level in pg/mL(From enrollment to the end of treatment at 12 weeks)
- adiponectin level in ug/mL(From enrollment to the end of treatment at 12 weeks)
- IL-1β in pg/mL(From enrollment to the end of treatment at 12 weeks)
- IL-2 in pg/mL(From enrollment to the end of treatment at 12 weeks)
- IL-4 in pg/mL(From enrollment to the end of treatment at 12 weeks)
- IL-6 in pg/mL(From enrollment to the end of treatment at 12 weeks)
- IL-10 in pg/mL(From enrollment to the end of treatment at 12 weeks)
- IFN-γ in pg/mL(From enrollment to the end of treatment at 12 weeks)
- TNF-α in pg/mL(From enrollment to the end of treatment at 12 weeks)
- height in centimeters(From enrollment to the end of treatment at 12 weeks)
- weight in kilograms(From enrollment to the end of treatment at 12 weeks)
- BMI in kg/m^2(From enrollment to the end of treatment at 12 weeks)
- body fat rate in %(From enrollment to the end of treatment at 12 weeks)
- muscle mass in kilograms(From enrollment to the end of treatment at 12 weeks)
- basal metabolic rate in kcal(From enrollment to the end of treatment at 12 weeks)
- skeletal muscle mass in kilograms(From enrollment to the end of treatment at 12 weeks)
- blood pressure in mmHg(From enrollment to the end of treatment at 12 weeks)
- waist circumference in millimeters(From enrollment to the end of treatment at 12 weeks)
- hip circumference in millimeters(From enrollment to the end of treatment at 12 weeks)
- upper arm circumference in millimeters(From enrollment to the end of treatment at 12 weeks)
- left hand grip strength in pound-force(From enrollment to the end of treatment at 12 weeks)
- right hand grip strength in pound-force(From enrollment to the end of treatment at 12 weeks)
- triceps skinfold thickness in millimeters(From enrollment to the end of treatment at 12 weeks)
- subscapular horn skinfold thickness in millimeters(From enrollment to the end of treatment at 12 weeks)
- abdominal skinfold thickness in millimeters(From enrollment to the end of treatment at 12 weeks)
- food intake dose in grams(From enrollment to the end of treatment at 12 weeks)
研究者
Cui Mingxuan
Principal Investigator
Peking University People's Hospital