Effects of Barley Green in Patients With Hyperuricemia

Study Overview
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Brief Summary
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This experiment evaluates the effect of Barley Green in patients with hyperuricemia ， and explores the effect of Barley Green on metabolic indexes such as uric acid, blood lipids, blood glucose, free fatty acids。130 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm A (control group) will receive dietary guidance. Arm B will receive dietary guidance and Barley Green.

Official Title
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Effects of Barley Green in Patients With Hyperuricemia

Conditions
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Dietary Supplement

Intervention / Treatment
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* Behavioral: Group A
* Dietary Supplement: Group B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years old those who are willing to accept assessment and sign informed consent. Under the normal purine diet, two fasting blood uric acid levels on different days: 420umol/l <blood uric acid <540 umol/l (male), 360 umol/l <blood uric acid <540 umol/l (female) Exclusion Criteria: Patients currently receiving treatment for hyperuricemia； Suffering from diseases that affect the digestion and absorption(such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcers, after gastrointestinal resection, cholecystitis/cholecystectomy, etc.)； Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases; At the same time receive other functional food nutrition support (plant active substances, health food); Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeds 3 times the upper limit of normal value); patients with abnormal renal function (serum creatinine exceeds the upper limit of normal value)； Suffering from infectious diseases such as active tuberculosis and AIDS; People who are severely allergic to the ingredients of research； During pregnancy or lactation; Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, suffering from serious diseases not included in the discharge criteria)； Gouty arthritis attack ≥ 2 times; One episode of gouty arthritis with blood uric acid >480 umol/l, or any of the following: age <40 years old, evidence of gout stone or urate deposition in the joint cavity, uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, coronary heart disease, stroke, cardiac insufficiency; Blood uric acid>480 umol/l combined with any of the following: uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, Coronary heart disease, stroke, heart failure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dietary advice<br> | Behavioral: Group A<br>* specific dietary advice for Hyperuricemia<br>|
| Experimental: dietary advice+ Barely Green<br> | Dietary Supplement: Group B<br>* Barely Green（three times a day, 5g(10 tablets)） dietary advice for Hyperuricemia as Group A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uric acid level |  | 3 months |