Effect of Prebiotics on Hyperuricemia

An Interventional Study for the Beneficial Effects of Prebiotics on Hyperuricemia in Chinese Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Subjects With Hyperuricemia
• Intervention / Treatment: Dietary supplement: anserine; Dietary supplement: Sunflower peptide; Dietary supplement: Placebo control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Xia, PhD; Phone Number: +86-20-87332433; Email: xiamin@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Sun Yat-sen University
      • Contact: Min Xia, PhD; Phone Number: +86-2087332433; Email: xiamin@mail.sysu.edu.cn
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Department of Nutrition and Food Hygiene
      • Contact: Min Xia, PhD; Phone Number: +86 20 87332433; Email: xiamin@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary Supplement: anserine; Subjects are instructed to take one capsule of anserine daily for a total of 3 months	Dietary supplement: anserine; 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.
Experimental: Dietary Supplement: Sunflower peptide; Subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months	Dietary supplement: Sunflower 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.
Placebo Comparator: Dietary Supplement: Placebo control; Subjects are instructed to take one capsule of placebo daily for a total of 3 months	Dietary supplement: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of serum Uric acid	change of fasting uric acid level assessed by biochemical detector	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	from baseline to 12 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Gut microbiota	Alterations of the composition of gut microbiota evaluated by metagenomics	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	from baseline to 12 weeks after intervention
Change in blood pressure	Change in blood pressure assessed by electronic sphygmomanometer	from baseline to 12 weeks after intervention
Change in fasting glucose	Change in fasting glucose assessed by biochemical detector	from baseline to 12 weeks after intervention
Change in waist circumference	Change in waist circumference assessed by tape	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	from baseline to 12 weeks after intervention

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Min Xia, PhD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: Pre-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No