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NCT Number: NCT06420401

Prebiotics and the Management of Hyperuricemia

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition and Food Hygiene, Guangzhou, Guangdong, China

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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 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.

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);
  • 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.

Treatment and study plan

araboxylan

Dietary Supplement

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.

Inulin

Dietary Supplement

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.

inulin and araboxylan

Dietary Supplement

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 Control

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 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.

Primary outcomes

  1. Change of serum uric acid

    Time frame: from baseline to 12 weeks after intervention

    change of fasting uric acid level assessed by biochemical detector

  2. Change of excretion of uric acid

    Time frame: from baseline to 12 weeks after intervention

    excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours

Secondary outcomes

  1. Change of gut microbiota

    Time frame: from baseline to 12 weeks after intervention

    Alterations of the composition of gut microbiota evaluated by metagenomics

  2. Change of microbial metabolites

    Time frame: 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

  3. Change in insulin sensitivity

    Time frame: from baseline to 12 weeks after intervention

    HOMA-IR will be used to assess the change of insulin sensitivity

  4. Change in waist circumference

    Time frame: from baseline to 12 weeks after intervention

    change in waist circumference assessed by tape

  5. Change in blood pressure

    Time frame: from baseline to 12 weeks after intervention

    change in blood pressure assessed by electronic sphymomanometer

  6. Change in lipid profiles

    Time frame: from baseline to 12 weeks after intervention

    change in total cholesterol, triglycerides, LDL-c and HDL-c assessed by biochemical detector

Study contacts

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

Yan Liu, PhD

CONTACT

[email protected]

+86-20-87331974

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Precision Treatment of Hyperuricemia Based on Different Combinations of Prebiotics

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 20, 2024
Registry last updated
Jun 5, 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.

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