An interventional study of araboxylan and inulin in Subjects With Hyperuricemia, sponsored by Sun Yat-sen University. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Prevention
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.
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.
240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.
This study's planned enrollment of 160 is above the median of 68 across 193 interventional studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
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Local residents aged between 18-80 years old;
Exclusion Criteria:
Acute illness or evidence of any acute or chronic inflammatroy of infective diseases;
Eligilable subjects are instructed to take one pocket of araboxylan during the first week, followed by two pockets of araboxylan during the remaining 11 weeks.
Dietary Supplement: araboxylan
Eligilable subjects are instructed to take one pocket of inulin during the first week, followed by two pockets of inulin during the remaining 11 weeks.
Dietary Supplement: inulin
Eligilable subjects are instructed to take one pocket of inulin and arabosylan during the first week, followed by two pockets of inulin and araboxylan during the remaining 11 weeks.
Dietary Supplement: inulin and araboxylan
Eligilable subjects are instructed to take one pocket of maltodextrin during the first week, followed by two pockets of maltodextrin during the remaining 11 weeks.
Dietary Supplement: placebo control
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.
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.
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.
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.
Change of serum uric acid
change of fasting uric acid level assessed by biochemical detector
Time frame: from baseline to 12 weeks after intervention
Change of excretion of uric acid
excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours
Time frame: from baseline to 12 weeks after intervention
Change of gut microbiota
Alterations of the composition of gut microbiota evaluated by metagenomics
Time frame: from baseline to 12 weeks after intervention
Change of microbial metabolites
Untargeted metabolomics will be used to assess the alterations of microbial metabolites with high performance liquid chromatography-mass spectrometry
Time frame: from baseline to 12 weeks after intervention
Change in insulin sensitivity
HOMA-IR will be used to assess the change of insulin sensitivity
Time frame: from baseline to 12 weeks after intervention
Change in waist circumference
change in waist circumference assessed by tape
Time frame: from baseline to 12 weeks after intervention
Change in blood pressure
change in blood pressure assessed by electronic sphymomanometer
Time frame: from baseline to 12 weeks after intervention
Change in lipid profiles
change in total cholesterol, triglycerides, LDL-c and HDL-c assessed by biochemical detector
Time frame: from baseline to 12 weeks after intervention
Plan to share: No
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Studies of the drug tested here: Inulin