Prebiotics and the Management of Hyperuricemia

Precision Treatment of Hyperuricemia Based on Different Combinations of Prebiotics

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.

Study Overview

• Status: Recruiting
• Conditions: Subjects With Hyperuricemia
• Intervention / Treatment: Dietary supplement: araboxylan; Dietary supplement: inulin; Dietary supplement: inulin and araboxylan; Dietary supplement: placebo control

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Liu, PhD; Phone Number: +86-20-87331974; Email: liuyan215@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Sun Yat-sen University
      • Contact: Min Xia, PhD; Phone Number: +86-2087332433; Email: xiamin@mail.sysu.edu.cn
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Department of Nutrition and Food Hygiene
      • Contact: Min Xia, PhD; Phone Number: +86 20 87332433; Email: xiamin@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary supplement: 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.	Dietary supplement: araboxylan; During the study period, subjects are instructed to take one pocket of arabosylan per day during the first week, followed by two pockets of araboxylan per day during the remianing 11 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.
Experimental: Dietary supplement: 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; During the study period, subjects are instructed to take one pocket of inulin per day during the first week, followed by two pockets of inulin per day during the remianing 11 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.
Experimental: Dietary supplement: 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: inulin and araboxylan; During the study period, subjects are instructed to take one pocket of inulin and araboxylan per day during the first week, followed by two pockets of inulin and araboxylan per day during the remianing 11 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.
Placebo Comparator: Dietary supplement: placebo; 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: placebo control; 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 remianing 11 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: Prebiotics-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No