Peking University People's Hospital
Beijing, Xicheng District, 100044, China
Completed
NCT Number: NCT06876909
Clinical Effect Observation of Barley Green Intervention in Hyperuricemia Population and Related Mechanism Study of Xanthine Oxidase
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.
Completed
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Notify MeKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
barley green
Dietary SupplementOral administration: 30 minutes before meals Dosage: 4 g powder, 5 g tablet Frequency: 2 times a day
Primary outcomes
-
uric acid levels in umol/L
Time frame: 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.
Secondary outcomes
-
Xanthine oxidase activity in ng/mL
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
erythrocyte sedimentation rate in mm/h
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
antinuclear antibody in semi-quantitative
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
blood glucose in mmol/L
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
total cholesterol in mmol/L
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
triglycerides in mmol/L
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
high-density lipoprotein cholesterol in mmol/L
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
low-density lipoprotein cholesterol in mmol/L
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
C-reactive protein in mg/L
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
white blood cell count in 10^9/L
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
leptin level in pg/mL
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
adiponectin level in ug/mL
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
IL-1β in pg/mL
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
IL-2 in pg/mL
Time frame: From enrollment to the end of treatment at 12 weeks
IL-2 levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.
-
IL-4 in pg/mL
Time frame: From enrollment to the end of treatment at 12 weeks
IL-4 levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.
-
IL-6 in pg/mL
Time frame: From enrollment to the end of treatment at 12 weeks
IL-6 levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.
-
IL-10 in pg/mL
Time frame: From enrollment to the end of treatment at 12 weeks
IL-10 levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.
-
IFN-γ in pg/mL
Time frame: From enrollment to the end of treatment at 12 weeks
IFN-γ levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.
-
TNF-α in pg/mL
Time frame: From enrollment to the end of treatment at 12 weeks
TNF-α levels were measured by blood samples at two time points: the day of enrollment and 12 weeks after enrollment.
-
height in centimeters
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
weight in kilograms
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
BMI in kg/m^2
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
body fat rate in %
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
muscle mass in kilograms
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
basal metabolic rate in kcal
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
skeletal muscle mass in kilograms
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
blood pressure in mmHg
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
waist circumference in millimeters
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
hip circumference in millimeters
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
upper arm circumference in millimeters
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
left hand grip strength in pound-force
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
right hand grip strength in pound-force
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
triceps skinfold thickness in millimeters
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
subscapular horn skinfold thickness in millimeters
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
abdominal skinfold thickness in millimeters
Time frame: From enrollment to the end of treatment at 12 weeks
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.
-
food intake dose in grams
Time frame: From enrollment to the end of treatment at 12 weeks
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.
Sponsors and collaborators
Lead sponsor
Peking University People's Hospital
Other
Registry information
Important dates
- Study start
- 2021
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Mar 14, 2025
- Registry last updated
- Aug 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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