GOS and the Management of Hyperuricemia

Sun Yat-sen University70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Subjects With Hyperuricemia

Interventions

GOSDIETARY_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.

PlaceboDIETARY_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Local residents aged between 18-80 years old; * Stable weight (\<5% weight change over the past 3 months); * Fasting uric acid \> 420 umol/L for male and \> 360 umol/L for female on two different days; * Not taking uric acid lowering drugs or have stopped taking uric acid lowering drugs for over 4 weeks at the time of recruitment; * Absence of any diet or medication that might interfere with uric acid metabolism or gut microbiota, especially antibiotics, prebiotics or probiotics at the 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 surgey within the past 6 months or planned surgery during the trial period.

Locations (1)

Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Change of serum uric acid

change of serum uric acid level assessed by automatic biochemical detector

Time frame: 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

Time frame: from baseline to 8 weeks after intervention

Secondary Outcomes

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

Time frame: from baseline to 8 weeks after intervention

Change of microbial metabolites in the circulation

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

Time frame: from baseline to 8 weeks after intervention

Central Contacts

Yan Liu, PhD

CONTACT

+86-20-87331937 liuyan215@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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