Prebiotics and the Management of Hyperuricemia

NCT06420401 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-sen University

Phase

Not applicable

Started

2024-05-15

Last updated

2024-06-05

Condition(s) studied

Subjects With Hyperuricemia

Investigational drug(s) / intervention(s)

araboxylaninulininulin and araboxylanplacebo control

araboxylan: 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: 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: 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: 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

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 outcome measure(s)

Change of serum uric acid — from baseline to 12 weeks after intervention
change of fasting uric acid level assessed by biochemical detector
Change of excretion of uric acid — from baseline to 12 weeks after intervention
excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours

Trial sites (2)

Facility	City	Region	Status
Department of Nutrition and Food Hygiene	Guangzhou	Guangdong	Recruiting
Sun Yat-Sen University	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06420401 on ClinicalTrials.gov ↗ ← All trials in China