Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06630377

GOS and the Management of Hyperuricemia

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Min Xia, PhD

CONTACT

[email protected]

+86-2087332433

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GOS

Dietary 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.

Placebo

Dietary 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.

Primary outcomes

  1. Change of serum uric acid

    Time frame: from baseline to 8 weeks after intervention

    change of serum uric acid level assessed by automatic biochemical detector

  2. Change of excretion of uric acid

    Time frame: 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 outcomes

  1. Change of gut microbiota

    Time frame: 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

  2. Change of microbial metabolites in the circulation

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Liu, PhD

CONTACT

[email protected]

+86-20-87331937

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

The Effectiveness of Galactooligosaccharide on the Treatment of Hyperuricemia

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.