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Hyperuricemia is a major risk factor for many chronic diesease. Recently, gut mcirobiota has been identified as a novel therapeutic 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 the protective effects and potential mechanisms of galactooligosaccharide on hyperuricemia 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 galactooligosaccharide also has a protective effect in subjects with hyperuricemia remain under-explored. Moreover, the molecular mechanisms underlying the protective effect of galactooligosaccharide remains largely unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary intervention with GOS | Experimental | Eligible subjects are instructed to take one pocket of galactooligosaccharide during the first week, followed by two pockets of galactooligosaccharide during the remaining 7 weeks. |
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| Dietary intervention with Placebo | Placebo Comparator | Eligible subjects are instructed to take one pocket of maltodextrin during the first week, followed by two pockets of maltodextrin during the remaining 7 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GOS | Dietary Supplement | During the study period, subjects are instructed to take one pocket of galactooligosaccharide per day during the first week, followed by two pockets of galactooligosaccharide per day during the remaining 7 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 serum uric acid level assessed by automatic biochemical detector | from baseline to 8 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 with automatic biochemical detector | from baseline to 8 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change of gut microbiota | Alterations of the composition of gut microbiota evaluated by metabogenomics and qPCR analysis in fecal samples with specific primers designed for each bacterium of interest | from baseline to 8 weeks after intervention |
| Change of microbial metabolites in the circulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Liu, PhD | Contact | +86-20-87331937 | liuyan215@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Min Xia, PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Placebo | 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 remaining 7 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. |
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Untargeted and targeted metabolomics will be used to assess the alterations of microbial metabolites in the circulation with high performance liquid chromatography-mass spectrometry with internal standards |
| from baseline to 8 weeks after intervention |