Effect of Prebiotics on Hyperuricemia

Sun Yat-sen University

Status: Unknown

Conditions: Subjects With Hyperuricemia

Treatments: Dietary Supplement: Placebo control; Dietary Supplement: anserine; Dietary Supplement: Sunflower peptide

Study type: Interventional

Funder types: Other

Identifiers

NCT05385003

Pre-2022

Details and patient eligibility

About

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.

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.

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Dietary Supplement: anserine

Experimental group

Description:

Subjects are instructed to take one capsule of anserine daily for a total of 3 months

Treatment:

Dietary Supplement: anserine

Dietary Supplement: Sunflower peptide

Experimental group

Description:

Subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months

Treatment:

Dietary Supplement: Sunflower peptide

Dietary Supplement: Placebo control

Placebo Comparator group

Description:

Subjects are instructed to take one capsule of placebo daily for a total of 3 months

Treatment:

Dietary Supplement: Placebo control