Effect of Prebiotics on Hyperuricemia

Study Overview
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Brief Summary
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Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of Hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of Hyperuricemia through several mechanisms. This trial aims to examine its protective effect in humans.

Detailed Description
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Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of hyperuricemia through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids. However, whether administration of prebiotics also has a protective effect in subjects with Hyperuricemia remain unknown.

Official Title
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An Interventional Study for the Beneficial Effects of Prebiotics on Hyperuricemia in Chinese Subjects

Conditions
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Subjects With Hyperuricemia

Intervention / Treatment
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* Dietary Supplement: anserine
* Dietary Supplement: Sunflower peptide
* Dietary Supplement: Placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Local residents aged between 18-65 years old; Stable weight (<5% weight change over last 3 months); Fasting uric acid was > 420μmol/L for male and > 360μmol/L for female on two different days Those who have never taken uric acid lowering drugs or have stopped taking uric acid lowering drugs for at least four weeks; Absence of any diet or medication that might interfere with Uric acid metabolism and gut microbiota, especially antibiotics and probiotics at least 4 weeks before recruitment. Exclusion Criteria: Acute illness or evidence of any acute or chronic inflammatory of infective diseases; Participation in regular diet program more than 2 times per week in the latest 3 months prior to recruitment; Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study. Women of childbearing age who are pregnant, breast-feeding or preparing for pregnancy; Patients who had surgery within the past six months or planned surgery during the trial period

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Supplement: anserine<br>Subjects are instructed to take one capsule of anserine daily for a total of 3 months | Dietary Supplement: anserine<br>* During the study period, subjects are instructed to take one capsule of anserine daily for a total of 3 months. Aside from the prebiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.<br>|
| Experimental: Dietary Supplement: Sunflower peptide<br>Subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months | Dietary Supplement: Sunflower peptide<br>* During the study period, subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months. Aside from the prebiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.<br>|
| Placebo Comparator: Dietary Supplement: Placebo control<br>Subjects are instructed to take one capsule of placebo daily for a total of 3 months | Dietary Supplement: Placebo control<br>* During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum Uric acid | change of fasting uric acid level assessed by biochemical detector | from baseline to 12 weeks after intervention | 
| Change of excretion of uric acid | excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours | from baseline to 12 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Gut microbiota | Alterations of the composition of gut microbiota evaluated by metagenomics | from baseline to 12 weeks after intervention | 
| Change of Microbial metabolites | Untargeted metabolomics will be used to assess the alterations of microbial metabolites with High performance liquid chromatography-mass spectrometry | from baseline to 12 weeks after intervention | 
| Change in blood pressure | Change in blood pressure assessed by electronic sphygmomanometer | from baseline to 12 weeks after intervention | 
| Change in fasting glucose | Change in fasting glucose assessed by biochemical detector | from baseline to 12 weeks after intervention | 
| Change in waist circumference | Change in waist circumference assessed by tape | from baseline to 12 weeks after intervention | 
| Change in lipid profiles | Change in total cholesterol, triglycerides, LDL-c and HDL-c assessed by biochemical detector | from baseline to 12 weeks after intervention |