Prebiotics and the Management of Hyperuricemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: araboxylan, inulin, inulin and araboxylan, placebo control.
- Who it may be relevant to
- Registry conditions: Subjects With Hyperuricemia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Precision Treatment of Hyperuricemia Based on Different Combinations of Prebiotics
Overview
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.
Interventions
- Dietary supplement 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. - Dietary supplement 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. - Dietary supplement 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. - Dietary supplement 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.
Primary outcome measures
- Change of serum uric acid [Time frame: from baseline to 12 weeks after intervention]
- Change of excretion of uric acid [Time frame: from baseline to 12 weeks after intervention]
Secondary outcome measures (6)
- Change of gut microbiota [Time frame: from baseline to 12 weeks after intervention]
- Change of microbial metabolites [Time frame: from baseline to 12 weeks after intervention]
- Change in insulin sensitivity [Time frame: from baseline to 12 weeks after intervention]
- Change in waist circumference [Time frame: from baseline to 12 weeks after intervention]
- Change in blood pressure [Time frame: from baseline to 12 weeks after intervention]
- Change in lipid profiles [Time frame: from baseline to 12 weeks after intervention]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 2 centers
- Department of Nutrition and Food Hygiene — Guangzhou
- Sun Yat-Sen University — Guangzhou
Identifiers
NCT: NCT06420401 · Prebiotics-2024