GOS and the Management of Hyperuricemia

Not Applicable

Recruiting

• Conditions: Subjects With Hyperuricemia
• Interventions: Dietary Supplement: GOS; Dietary Supplement: Placebo

• Registration Number: NCT06630377
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2024-07-03
• Study Start: 2024-07-15
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary intervention with GOS	GOS	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.
Dietary intervention with Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change of serum uric acid	from baseline to 8 weeks after intervention	change of serum uric acid level assessed by automatic biochemical detector
Change of excretion of uric acid	from baseline to 8 weeks after intervention	excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours with automatic biochemical detector

Secondary Outcome Measures

Name	Time	Method
Change of gut microbiota	from baseline to 8 weeks after intervention	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
Change of microbial metabolites in the circulation	from baseline to 8 weeks after intervention	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

Trial Locations

Locations (1)

Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China