Clinical trial NCT05385003: Effect of Prebiotics on Hyperuricemia
Official title: An Interventional Study for the Beneficial Effects of Prebiotics on Hyperuricemia in Chinese Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subjects With Hyperuricemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 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. This trial aims to examine its protective effect in humans.

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.

However, whether administration of prebiotics also has a protective effect in subjects with Hyperuricemia remain unknown.

Eligibility criteria: Inclusion Criteria:

* Local residents aged between 18-65 years old;
* Stable weight (\<5% weight change over last 3 months);
* Fasting uric acid was \> 420μmol/L for male and \> 360μmol/L for female on two different days
* Those who have never taken uric acid lowering drugs or have stopped taking uric acid lowering drugs for at least four weeks;
* Absence of any diet or medication that might interfere with Uric acid metabolism and gut microbiota, especially antibiotics and probiotics at 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 surgery within the past six 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 blood pressure
timeFrame: from baseline to 12 weeks after intervention
measure: Change in fasting glucose
timeFrame: from baseline to 12 weeks after intervention
measure: Change in waist circumference
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:
affiliation: Sun Yat-sen University
name: Min Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References: