Subjects With Hyperuricemia
Conditions
Brief 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.
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_SUPPLEMENTaraboxylan
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_SUPPLEMENTinulin
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_SUPPLEMENTinulin 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_SUPPLEMENTplacebo 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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin sensitivity | from baseline to 12 weeks after intervention | HOMA-IR will be used to assess the change of insulin sensitivity |
| Change in waist circumference | from baseline to 12 weeks after intervention | change in waist circumference assessed by tape |
| Change of gut microbiota | from baseline to 12 weeks after intervention | Alterations of the composition of gut microbiota evaluated by metagenomics |
| Change in lipid profiles | from baseline to 12 weeks after intervention | change in total cholesterol, triglycerides, LDL-c and HDL-c assessed by biochemical detector |
| Change in blood pressure | from baseline to 12 weeks after intervention | change in blood pressure assessed by electronic sphymomanometer |
| Change of microbial metabolites | from baseline to 12 weeks after intervention | Untargeted metabolomics will be used to assess the alterations of microbial metabolites with high performance liquid chromatography-mass spectrometry |
Countries
China
Contacts
Primary ContactYan Liu, PhD
Outcome results
None listed