Subjects With HyperuricemiaNCT06420401
Prebiotics and the Management of Hyperuricemia
A study testing araboxylan, inulin and inulin and araboxylan 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 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjects With Hyperuricemia
- What is being tested?
- araboxylan, inulin and inulin and araboxylan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 15 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Local residents aged between 18-80 years old;
- Stable weight (<5% weight change over the past 3 months);
- Fsating uric acid > 420 umol/L for male and > 360 umol/L for female on two different days;
- Not taking uric acid lowering drugs or have stopped taking uric acid lowering drugs for over 4 weeks at the time of recruitment;
- Absence of any diet or medication that might interfere with uric acid metabolims or gut microbiota, especially antibiotics, prebiotics or probiotics at the least 4 weeks before recruitment
Who cannot join
- Acute illness or evidence of any acute or chronic inflammatroy of infective diseases;
- Participation in regular diet program more than 2 times per week in the lastest 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 pregant, breast-feeding or preparing for pregnancy; patients who had surgey within the past 6 months or planned surgery during the trial period.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
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: Precision Treatment of Hyperuricemia Based on Different Combinations of Prebiotics
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.
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 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.
- Conditions
- Subjects With Hyperuricemia
- Being tested
- araboxylan, inulin, inulin and araboxylan, placebo control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
araboxylanDietary supplement
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.
inulinDietary supplement
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.
inulin and araboxylanDietary supplement
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.
placebo controlDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement: araboxylan | Experimental | 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. Receives: Dietary Supplement: araboxylan |
| Dietary supplement: inulin | Experimental | 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. Receives: Dietary Supplement: inulin |
| Dietary supplement: inulin and araboxylan | Experimental | 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. Receives: Dietary Supplement: inulin and araboxylan |
| Dietary supplement: placebo | Placebo comparator | 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. 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 insulin sensitivity
HOMA-IR will be used to assess the change of insulin sensitivity
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 blood pressure
change in blood pressure assessed by electronic sphymomanometer
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 posted20 May 2024
- Study start15 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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
- 160 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420401
- Sponsor's protocol ID
- Prebiotics-2024
- Status last verified
- Jun 2024
- First submitted
- 14 May 2024
- Last updated
- 5 Jun 2024
- 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Treatment of Hyperuricemia Based on Different Combinations of Prebiotics
- ClinicalTrials.gov ID
- NCT06420401
- Acronym / sponsor ID
- Prebiotics-2024
- Conditions
- Subjects With Hyperuricemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 May 2024 (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 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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement: araboxylan | Experimental | Dietary Supplement: araboxylanEligilable 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: inulin | Experimental | Dietary Supplement: inulinEligilable 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 and araboxylan | Experimental | Dietary Supplement: inulin and araboxylanEligilable 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: placebo | Placebo comparator | Dietary Supplement: placebo controlEligilable subjects are instructed to take one pocket of maltodextrin during the first week, followed by two pockets of maltodextrin during the remaining 11 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Local residents aged between 18-80 years old;
Key exclusion criteria (4 listed)
- Acute illness or evidence of any acute or chronic inflammatroy of infective diseases;
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 |
|---|---|---|
| araboxylanDuring 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. | Dietary supplement | Dietary supplement: araboxylan |
| inulinDuring 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. | Dietary supplement | Dietary supplement: inulin |
| inulin and araboxylanDuring 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. | Dietary supplement | Dietary supplement: inulin and araboxylan |
| placebo controlDuring 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. | Dietary supplement | Dietary supplement: placebo |
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 insulin sensitivity
Time frame: from baseline to 12 weeks after intervention
Change in waist circumference
Time frame: from baseline to 12 weeks after intervention
Change in blood pressure
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing araboxylan, inulin and inulin and araboxylan 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: looking for participants now, as of the sponsor's last update on 5 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Liu, PhD (+86-20-87331974, liuyan215@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 5 Jun 2024.