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Hyperuricemia is a major risk factor for many chronic diesease. Recently, gut mcirobiota has been identified as a novel theraputic target for hyperuricemia. Both annimal studies and pilot human trials have demonstrated that administration of prebiotics help delay the progression of hyperuricemia throuh several mechanisms. This trial aims to examine its protective effects and potential mechanisms in clinical trials.
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 and hippuric acid.
However, whether administration of prebiotics also has a protective effect in subjects with hyperuricemia remain under-explored. Moreover, whether the original gut microbiota will influence the protective effect of prebiotics remains largely unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement: araboxylan | Experimental | Eligilable subjects are instructed to take one pocket of araboxylan during the first week, followed by two pockets of araboxylan during the remaining 11 weeks. |
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| Dietary supplement: inulin | Experimental | Eligilable subjects are instructed to take one pocket of inulin during the first week, followed by two pockets of inulin during the remaining 11 weeks. |
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| Dietary supplement: inulin and araboxylan | Experimental | Eligilable subjects are instructed to take one pocket of inulin and arabosylan during the first week, followed by two pockets of inulin and araboxylan during the remaining 11 weeks. |
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| Dietary supplement: placebo | Placebo Comparator | Eligilable subjects are instructed to take one pocket of maltodextrin during the first week, followed by two pockets of maltodextrin during the remaining 11 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| araboxylan | Dietary Supplement | During the study period, subjects are instructed to take one pocket of arabosylan per day during the first week, followed by two pockets of araboxylan per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity. |
| 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 |
| 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 |
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Inclusion Criteria:
Local residents aged between 18-80 years old;
Exclusion Criteria:
Acute illness or evidence of any acute or chronic inflammatroy of infective diseases;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Liu, PhD | Contact | +86-20-87331974 | liuyan215@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition and Food Hygiene | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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|
| inulin | Dietary Supplement | During the study period, subjects are instructed to take one pocket of inulin per day during the first week, followed by two pockets of inulin per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity. |
|
| inulin and araboxylan | Dietary Supplement | During the study period, subjects are instructed to take one pocket of inulin and araboxylan per day during the first week, followed by two pockets of inulin and araboxylan per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity. |
|
| placebo control | Dietary Supplement | During the study period, subjects are instructed to take one pocket of placebo control per day during the first week, followed by two pockets of placebo control per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity. |
|
| from baseline to 12 weeks after intervention |
| Change in insulin sensitivity | HOMA-IR will be used to assess the change of insulin sensitivity | 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 blood pressure | change in blood pressure assessed by electronic sphymomanometer | 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 |
| Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
|
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |