GOS and the Management of Hyperuricemia

Sun Yat-sen University

Status: Enrolling

Conditions: Subjects With Hyperuricemia

Treatments: Dietary Supplement: GOS; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06630377

GOS-HUA-2024

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Dietary intervention with GOS

Experimental group

Description:

Eligible subjects are instructed to take one pocket of galactooligosaccharide during the first week, followed by two pockets of galactooligosaccharide during the remaining 7 weeks.

Treatment:

Dietary Supplement: GOS

Dietary intervention with Placebo

Placebo Comparator group

Description:

Eligible subjects are instructed to take one pocket of maltodextrin during the first week, followed by two pockets of maltodextrin during the remaining 7 weeks.

Treatment:

Dietary Supplement: Placebo