Subjects With Hyperuricemia
Conditions
Brief summary
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.
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. However, whether administration of prebiotics also has a protective effect in subjects with Hyperuricemia remain unknown.
Interventions
DIETARY_SUPPLEMENTanserine
During the study period, subjects are instructed to take one capsule of anserine daily for a total of 3 months. Aside from the prebiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.
DIETARY_SUPPLEMENTSunflower peptide
During the study period, subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months. Aside from the prebiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.
DIETARY_SUPPLEMENTPlacebo control
During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.
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 65 Years
Healthy volunteers
Yes
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
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 blood pressure | from baseline to 12 weeks after intervention | Change in blood pressure assessed by electronic sphygmomanometer |
| Change in fasting glucose | from baseline to 12 weeks after intervention | Change in fasting glucose assessed by biochemical detector |
| 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 waist circumference | from baseline to 12 weeks after intervention | Change in waist circumference assessed by tape |
| 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 ContactMin Xia, PhD
Outcome results
None listed