Clinical trial NCT06420401: Prebiotics and the Management of Hyperuricemia
Official title: Precision Treatment of Hyperuricemia Based on Different Combinations of Prebiotics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subjects With Hyperuricemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of serum uric acid
timeFrame: from baseline to 12 weeks after intervention
measure: Change of excretion of uric acid
timeFrame: from baseline to 12 weeks after intervention
Secondary outcomes:
measure: Change of gut microbiota
timeFrame: from baseline to 12 weeks after intervention
measure: Change of microbial metabolites
timeFrame: from baseline to 12 weeks after intervention
measure: Change in insulin sensitivity
timeFrame: from baseline to 12 weeks after intervention
measure: Change in waist circumference
timeFrame: from baseline to 12 weeks after intervention
measure: Change in blood pressure
timeFrame: from baseline to 12 weeks after intervention
measure: Change in lipid profiles
timeFrame: from baseline to 12 weeks after intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nutrition and Food Hygiene
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen University
state: Guangdong
Study officials:
References: