Back to resultsEffect of Prebiotics on Hyperuricemia
Primary Purpose
Subjects With Hyperuricemia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
anserine
Sunflower peptide
Placebo control
Sponsored by
About this trial
This is an interventional prevention trial for Subjects With Hyperuricemia
Eligibility Criteria
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
Sites / Locations
- Department of Nutrition and Food HygieneRecruiting
- Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Dietary Supplement: anserine
Dietary Supplement: Sunflower peptide
Dietary Supplement: Placebo control
Arm Description
Subjects are instructed to take one capsule of anserine daily for a total of 3 months
Subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months
Subjects are instructed to take one capsule of placebo daily for a total of 3 months
Outcomes
Primary Outcome Measures
Change of serum Uric acid
change of fasting uric acid level assessed by biochemical detector
Change of excretion of uric acid
excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours
Secondary Outcome Measures
Change of Gut microbiota
Alterations of the composition of gut microbiota evaluated by metagenomics
Change of Microbial metabolites
Untargeted metabolomics will be used to assess the alterations of microbial metabolites with High performance liquid chromatography-mass spectrometry
Change in blood pressure
Change in blood pressure assessed by electronic sphygmomanometer
Change in fasting glucose
Change in fasting glucose assessed by biochemical detector
Change in waist circumference
Change in waist circumference assessed by tape
Change in lipid profiles
Change in total cholesterol, triglycerides, LDL-c and HDL-c assessed by biochemical detector
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05385003
Brief Title
Effect of Prebiotics on Hyperuricemia
Official Title
An Interventional Study for the Beneficial Effects of Prebiotics on Hyperuricemia in Chinese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects With Hyperuricemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary Supplement: anserine
Arm Type
Experimental
Arm Description
Subjects are instructed to take one capsule of anserine daily for a total of 3 months
Arm Title
Dietary Supplement: Sunflower peptide
Arm Type
Experimental
Arm Description
Subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months
Arm Title
Dietary Supplement: Placebo control
Arm Type
Placebo Comparator
Arm Description
Subjects are instructed to take one capsule of placebo daily for a total of 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
anserine
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Sunflower peptide
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of serum Uric acid
Description
change of fasting uric acid level assessed by biochemical detector
Time Frame
from baseline to 12 weeks after intervention
Title
Change of excretion of uric acid
Description
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
Secondary Outcome Measure Information:
Title
Change of Gut microbiota
Description
Alterations of the composition of gut microbiota evaluated by metagenomics
Time Frame
from baseline to 12 weeks after intervention
Title
Change of Microbial metabolites
Description
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
Title
Change in blood pressure
Description
Change in blood pressure assessed by electronic sphygmomanometer
Time Frame
from baseline to 12 weeks after intervention
Title
Change in fasting glucose
Description
Change in fasting glucose assessed by biochemical detector
Time Frame
from baseline to 12 weeks after intervention
Title
Change in waist circumference
Description
Change in waist circumference assessed by tape
Time Frame
from baseline to 12 weeks after intervention
Title
Change in lipid profiles
Description
Change in total cholesterol, triglycerides, LDL-c and HDL-c assessed by biochemical detector
Time Frame
from baseline to 12 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Xia, PhD
Phone
+86-20-87332433
Email
xiamin@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Xia, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition and Food Hygiene
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Xia, PhD
Phone
+86 20 87332433
Email
xiamin@mail.sysu.edu.cn
Facility Name
Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Xia, PhD
Phone
+86-2087332433
Email
xiamin@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Prebiotics on Hyperuricemia
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