Investigation of the Atherogenic Effects of Uric Acid-modified in Endothelial Dysfunction and the the Preventional Mechanism by Anthocyanidines

Study Overview
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Brief Summary
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The purpose of this study is to confirm the protective effect and mechanism of anthocyanins on hyperuricemia patients with Cardiovascular disease.

Detailed Description
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Hyperuricemia patients who have the ability to complete the intervention study in the early stage of study were selected as the research subjects. A randomized controlled double blind control method was used to study the effect of one year of anthocyanins intervention. Serum UA levels, oxidative stress, AGEs, and endothelial function are detecting in patients with hyperuricemia who were treated with anthocyanins and placebo. Providing scientific basis of anthocyanins for the treatment with hyperuricemia and delaying atherosclerosis.

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Anthocyanidins capsule
* Dietary Supplement: Placebo capsule
* Drug: Allopurinol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Serum uric acid >420μmol/L (7mg/dL) in male, >360μmol/L (6mg/dL) in female identified as hyperuricemia patients. Exclusion Criteria: Age more than 60 years and less than 30 years old; acute infection, tumor, recent surgery, need for hemodialysis and autoimmune diseases.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo capsule<br>Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. Control group taking placebo capsule | Dietary Supplement: Placebo capsule<br>* Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months<br>|
| Experimental: Anthocyanidins capsule<br>Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. The experimental group taking anthocyanins capsule. | Dietary Supplement: Anthocyanidins capsule<br>* Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months<br>|
| Experimental: Allopurinol<br>The experimental group taking allopurinol. | Drug: Allopurinol<br>* Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of serum uric acid levels in all patients | Serum uric acid (mg/dl) is determined by Uric Acid kit on an automated system. | up to 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of advanced glycation end products and its receptor level in all patients | Advanced glycation end products and its receptor level are determined by high efficiency liquid chromatography. | up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperuricemia, endothelial function, anthocyanidins