Prebiotics and the Management of Hyperuricemia

Not Applicable

Recruiting

• Conditions: Subjects With Hyperuricemia
• Interventions: Dietary Supplement: placebo control; Dietary Supplement: inulin; Dietary Supplement: inulin and araboxylan; Dietary Supplement: araboxylan

• Registration Number: NCT06420401
• 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 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.

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 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.

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study Start: 2024-05-15
• Study First Posted: 2024-05-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Local residents aged between 18-80 years old;

  • Stable weight (<5% weight change over the past 3 months);
  • Fsating 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 metabolims 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 inflammatroy of infective diseases;

  • Participation in regular diet program more than 2 times per week in the lastest 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 pregant, 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 supplement: placebo	placebo control	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.
Dietary supplement: inulin	inulin	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.
Dietary supplement: inulin and araboxylan	inulin and araboxylan	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.
Dietary supplement: araboxylan	araboxylan	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.

Primary Outcome Measures

Name	Time	Method
Change of excretion of uric acid	from baseline to 12 weeks after intervention	excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours
Change of serum uric acid	from baseline to 12 weeks after intervention	change of fasting uric acid level assessed by biochemical detector

Secondary Outcome Measures

Name	Time	Method
Change of gut microbiota	from baseline to 12 weeks after intervention	Alterations of the composition of gut microbiota evaluated by metagenomics
Change of microbial metabolites	from baseline to 12 weeks after intervention	Untargeted metabolomics will be used to assess the alterations of microbial metabolites with high performance liquid chromatography-mass spectrometry
Change in insulin sensitivity	from baseline to 12 weeks after intervention	HOMA-IR will be used to assess the change of insulin sensitivity
Change in waist circumference	from baseline to 12 weeks after intervention	change in waist circumference assessed by tape
Change in lipid profiles	from baseline to 12 weeks after intervention	change in total cholesterol, triglycerides, LDL-c and HDL-c assessed by biochemical detector
Change in blood pressure	from baseline to 12 weeks after intervention	change in blood pressure assessed by electronic sphymomanometer

Trial Locations

Locations (2)

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

Department of Nutrition and Food Hygiene; 🇨🇳 Guangzhou, Guangdong, China