Subjects With HyperuricemiaNCT05385003
Effect of Prebiotics on Hyperuricemia
A study testing anserine and Sunflower peptide in people with Subjects With Hyperuricemia, run by Sun Yat-sen University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjects With Hyperuricemia
- What is being tested?
- anserine and Sunflower peptide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 14 May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Department of Nutrition and Food Hygiene
Guangzhou, Guangdong, 510080
Min Xia, PhD, +86 20 87332433, xiamin@mail.sysu.edu.cn
- Recruiting
Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Min Xia, PhD, +86-2087332433, xiamin@mail.sysu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Subjects With Hyperuricemia
- Being tested
- anserine, Sunflower peptide, Placebo control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anserineDietary supplement
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.
Sunflower peptideDietary supplement
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 controlDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: anserine | Experimental | Subjects are instructed to take one capsule of anserine daily for a total of 3 months Receives: Dietary Supplement: anserine |
| Dietary Supplement: Sunflower peptide | Experimental | Subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months Receives: Dietary Supplement: Sunflower peptide |
| Dietary Supplement: Placebo control | Placebo comparator | Subjects are instructed to take one capsule of placebo daily for a total of 3 months Receives: Dietary Supplement: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum Uric acid
change of fasting uric acid level assessed by biochemical detector
Measured: 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
Measured: from baseline to 12 weeks after intervention
Secondary outcomes (6)
Change of Gut microbiota
Alterations of the composition of gut microbiota evaluated by metagenomics
Measured: 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
Measured: from baseline to 12 weeks after intervention
Change in blood pressure
Change in blood pressure assessed by electronic sphygmomanometer
Measured: from baseline to 12 weeks after intervention
Change in fasting glucose
Change in fasting glucose assessed by biochemical detector
Measured: from baseline to 12 weeks after intervention
Change in waist circumference
Change in waist circumference assessed by tape
Measured: 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
Measured: from baseline to 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start14 May 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Xia, Sun Yat-sen University
- Investigators
- Min Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385003
- Sponsor's protocol ID
- Pre-2022
- Status last verified
- May 2022
- First submitted
- 13 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study for the Beneficial Effects of Prebiotics on Hyperuricemia in Chinese Subjects
- ClinicalTrials.gov ID
- NCT05385003
- Acronym / sponsor ID
- Pre-2022
- Conditions
- Subjects With Hyperuricemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 May 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: anserine | Experimental | Dietary Supplement: anserineSubjects are instructed to take one capsule of anserine daily for a total of 3 months |
| Dietary Supplement: Sunflower peptide | Experimental | Dietary Supplement: Sunflower peptideSubjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months |
| Dietary Supplement: Placebo control | Placebo comparator | Dietary Supplement: Placebo controlSubjects are instructed to take one capsule of placebo daily for a total of 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anserineDuring 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 supplement | Dietary Supplement: anserine |
| Sunflower peptideDuring 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 supplement | Dietary Supplement: Sunflower peptide |
| Placebo controlDuring 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. | Dietary supplement | Dietary Supplement: Placebo control |
Primary outcome
Change of serum Uric acid
Time frame: from baseline to 12 weeks after intervention
change of fasting uric acid level assessed by biochemical detector
Change of excretion of uric acid
Time frame: from baseline to 12 weeks after intervention
excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours
6 secondary outcomes
Change of Gut microbiota
Time frame: from baseline to 12 weeks after intervention
Change of Microbial metabolites
Time frame: from baseline to 12 weeks after intervention
Change in blood pressure
Time frame: from baseline to 12 weeks after intervention
Change in fasting glucose
Time frame: from baseline to 12 weeks after intervention
Change in waist circumference
Time frame: from baseline to 12 weeks after intervention
Change in lipid profiles
Time frame: from baseline to 12 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Xia, PhD principal investigator
Sun Yat-sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anserine and Sunflower peptide in people with Subjects With Hyperuricemia, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Xia, PhD (+86-20-87332433, xiamin@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum Uric acid (time frame: from baseline to 12 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.