Clinical trial NCT06630377: GOS and the Management of Hyperuricemia
Official title: The Effectiveness of Galactooligosaccharide on the Treatment of Hyperuricemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subjects With Hyperuricemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of serum uric acid
timeFrame: from baseline to 8 weeks after intervention
measure: Change of excretion of uric acid
timeFrame: from baseline to 8 weeks after intervention
Secondary outcomes:
measure: Change of gut microbiota
timeFrame: from baseline to 8 weeks after intervention
measure: Change of microbial metabolites in the circulation
timeFrame: from baseline to 8 weeks after intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Min Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References: