HyperuricemiaNCT06591767
Quercetin as Possible Supportive Therapy for Mild to Moderate Hyperuricemia
A study testing Quercetin and Berberol K® in people with Hyperuricemia, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial summary
Uric acid, a metabolic byproduct of purine degradation in humans, is a known risk factor for conditions such as gout and type 2 diabetes. Research has shown that supplementation with quercetin can significantly reduce plasma uric acid levels in individuals with mild hyperuricemia, potentially mitigating these… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Quercetin and Berberol K®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2023to 31 Aug 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years.
- Diagnosed with obesity.
- Diagnosed with hypercholesterolemia.
- With or without moderate hyperuricemia (serum uric acid ≥ 8 mg/dL).
- No restrictions on BMI, alcohol consumption, or smoking habits.
Who cannot join
- Current use of uric acid-lowering medications (e.g., allopurinol, febuxostat).
- Diagnosed with oncological diseases.
- Diagnosed with neurological diseases.
- Diagnosed with inflammatory bowel diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Pharmacological Effects of Supplemental Quercetin in the Management of Mild to Moderate Hyperuricemia
Uric acid, a metabolic byproduct of purine degradation in humans, is a known risk factor for conditions such as gout and type 2 diabetes. Research has shown that supplementation with quercetin can significantly reduce plasma uric acid levels in individuals with mild hyperuricemia, potentially mitigating these associated risks.
Read the detailed description
Uric acid, a metabolic byproduct of purine degradation in humans, is a significant risk factor for the development of gout and type 2 diabetes. Supplementation with quercetin, a flavonol not naturally produced by the human body, has been shown to significantly reduce plasma uric acid levels in individuals with mild hyperuricemia. This effect is primarily achieved through the inhibition of xanthine oxidoreductase, an enzyme crucial to uric acid production.
Quercetin is the most abundant polyphenol found in fruits and vegetables and is widely used as a dietary supplement to boost the immune system and promote overall health. It is characterized by three key properties: antioxidant, anti-inflammatory, and immunomodulatory. These combined actions make quercetin a promising candidate for supporting various health conditions where oxidative stress, inflammation, and immune function play a role, including cardiovascular health, healthy aging, bone and joint health, sports and physical activity, gut health, and respiratory well-being.
The above-described properties of quercetin prompted investigators to explore its potential uricosuric therapeutic effect in two clinical studies. The first study will assess this effect in a retrospective cohort of COVID-19 patients who received quercetin as a supplemental therapy. In the second study, its potential uricosuric therapeutic effect will be assessed in a randomized controlled prospective clinical trial involving patients with mild to moderate hyperuricemia.
- Conditions
- Hyperuricemia
- Being tested
- Quercetin, Berberol K®
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinDietary supplement
Also called Quevir®
200 mg supplemental Quercefit®
Berberol K®Combination product
Berberine Phytosome® 730 mg
+ MonakoPure® containing 2.9 mg of monacolin K and KA from red yeast rice extract
| Study group | Role | What they receive |
|---|---|---|
| Quercetin group | Experimental | In this group hyperuricemic patients (uric acid > 8 mg/dL) received oral supplemental Quercetin, twice a day for 90 days. Receives: Dietary Supplement: Quercetin |
| Control group 1 | Active comparator | In this group hyperuricemic patients (uric acid > 8 mg/dL) received oral supplemental Berberine and monacolins based supplement, twice a day for 90 days. Receives: Combination Product: Berberol K® |
| Control group 2 | Active comparator | In this group normouricemic patients (uric acid < 7 mg/dL) received oral supplemental Berberine and monacolins based supplement, twice a day for 90 days. Receives: Combination Product: Berberol K® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on circulatory uric acid
Change in plasma uric acid level
Measured: 90 days
Secondary outcomes (11)
Effect on lipids
Change in plasma cholesterol level
Measured: 90 days
Effect on lipids
Change in plasma triglycerides level
Measured: 90 days
Effect on glycemia
Change in plasma glucose level
Measured: 90 days
Effect on glycemia
Change in plasma insulin level
Measured: 90 days
Effect on body internal organs muscles
Change in the Creatine Phosphokinase (CPK) levels
Measured: 90 days
Effect on liver function
Change in the Alanine Aminotransferase levels
Measured: 90 days
Effect on liver function
Change in the Aspartate Aminotransferase levels
Measured: 90 days
Effect on liver function
Change in the Alkaline Phosphatase levels
Measured: 90 days
Effect on liver function
Change in the Gamma-Glutamyl Transferase levels
Measured: 90 days
Effect on liver function
Change in the Bilirubin levels
Measured: 90 days
Supplement safety and tolerability
Number of patients reporting possible side effects
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2023
- Primary completion30 Apr 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591767
- Sponsor's protocol ID
- 88_18.01.2023_QuercetinFit
- Status last verified
- Oct 2024
- First submitted
- 8 Sep 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Pharmacological Effects of Supplemental Quercetin in the Management of Mild to Moderate Hyperuricemia
- ClinicalTrials.gov ID
- NCT06591767
- Acronym / sponsor ID
- 88_18.01.2023_QuercetinFit
- Conditions
- Hyperuricemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 19 Sep 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.
Uric acid, a metabolic byproduct of purine degradation in humans, is a known risk factor for conditions such as gout and type 2 diabetes. Research has shown that supplementation with quercetin can significantly reduce plasma uric acid levels in individuals with mild hyperuricemia, potentially mitigating these associated risks.
Detailed description
Uric acid, a metabolic byproduct of purine degradation in humans, is a significant risk factor for the development of gout and type 2 diabetes. Supplementation with quercetin, a flavonol not naturally produced by the human body, has been shown to significantly reduce plasma uric acid levels in individuals with mild hyperuricemia. This effect is primarily achieved through the inhibition of xanthine oxidoreductase, an enzyme crucial to uric acid production.
Quercetin is the most abundant polyphenol found in fruits and vegetables and is widely used as a dietary supplement to boost the immune system and promote overall health. It is characterized by three key properties: antioxidant, anti-inflammatory, and immunomodulatory. These combined actions make quercetin a promising candidate for supporting various health conditions where oxidative stress, inflammation, and immune function play a role, including cardiovascular health, healthy aging, bone and joint health, sports and physical activity, gut health, and respiratory well-being.
The above-described properties of quercetin prompted investigators to explore its potential uricosuric therapeutic effect in two clinical studies. The first study will assess this effect in a retrospective cohort of COVID-19 patients who received quercetin as a supplemental therapy. In the second study, its potential uricosuric therapeutic effect will be assessed in a randomized controlled prospective clinical trial involving patients with mild to moderate hyperuricemia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quercetin group | Experimental | Dietary Supplement: QuercetinIn this group hyperuricemic patients (uric acid > 8 mg/dL) received oral supplemental Quercetin, twice a day for 90 days. |
| Control group 1 | Active comparator | Combination Product: Berberol K®In this group hyperuricemic patients (uric acid > 8 mg/dL) received oral supplemental Berberine and monacolins based supplement, twice a day for 90 days. |
| Control group 2 | Active comparator | Combination Product: Berberol K®In this group normouricemic patients (uric acid < 7 mg/dL) received oral supplemental Berberine and monacolins based supplement, twice a day for 90 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 75 years.
- Diagnosed with obesity.
- Diagnosed with hypercholesterolemia.
- With or without moderate hyperuricemia (serum uric acid ≥ 8 mg/dL).
- No restrictions on BMI, alcohol consumption, or smoking habits.
Key exclusion criteria (4 listed)
- Current use of uric acid-lowering medications (e.g., allopurinol, febuxostat).
- Diagnosed with oncological diseases.
- Diagnosed with neurological diseases.
- Diagnosed with inflammatory bowel 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 |
|---|---|---|
| QuercetinAlso: Quevir®200 mg supplemental Quercefit® | Dietary supplement | Quercetin group |
| Berberol K®Berberine Phytosome® 730 mg + MonakoPure® containing 2.9 mg of monacolin K and KA from red yeast rice extract | Combination product | Control group 1, Control group 2 |
Primary outcome
Effect on circulatory uric acid
Time frame: 90 days
Change in plasma uric acid level
11 secondary outcomes
Effect on lipids
Time frame: 90 days
Effect on lipids
Time frame: 90 days
Effect on glycemia
Time frame: 90 days
Effect on glycemia
Time frame: 90 days
Effect on body internal organs muscles
Time frame: 90 days
Effect on liver function
Time frame: 90 days
Effect on liver function
Time frame: 90 days
Effect on liver function
Time frame: 90 days
Effect on liver function
Time frame: 90 days
Effect on liver function
Time frame: 90 days
Supplement safety and tolerability
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quercetin and Berberol K® in people with Hyperuricemia, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
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: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on circulatory uric acid (time frame: 90 days). 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 17 Oct 2024.