Hyperuricemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTbarley green
Oral administration: 30 minutes before meals Dosage: 4 g powder, 5 g tablet Frequency: 2 times a day
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| uric acid levels in umol/L | 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
| Measure | Time frame | Description |
|---|---|---|
| erythrocyte sedimentation rate in mm/h | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Xanthine oxidase activity in ng/mL | 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. |
| height in centimeters | 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 | 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 | 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 % | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| TNF-α in pg/mL | 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. |
Countries
China
Outcome results
None listed