HyperuricemiaNCT06652035
Possible Pharmacological Effect of Quercetin in the Management of Hyperuricemia - Results From Real-life Clinical Studies
An observational study of Hyperuricemia, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial summary
Quercetin, a natural flavonoid found in various fruits and vegetables, has gained attention for its potential role in managing hyperuricemia. Emerging evidence suggests that quercetin may reduce plasma uric acid levels by inhibiting xanthine oxidase, an enzyme responsible for uric acid production. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Quevir® (Quercetin Phytosome®) and Bactoblis®
- Type of treatment
- Pill or oral medicine
- How many people
- 161 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 15 Jun 2023
- Phase
- Observational
- 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
Study population: Healthy participants visited the nutritional clinics during the COVID-19 pandemic for general health check up to improve their immunological protection against COVID-19 infection.
Who may be able to join
- Healthy adults
- BMI between 18.5 and 29.9 kg/m²
- Non-smoker
- Consumtion of less than 3 units of alcohol per day
Who cannot join
- - Plasma uric acid concentrations above 7 mg/dL
- Diagnosis of endocrinological, metabolic, oncological, neurological, or bowel inflammatory disease diseases, gout, kidney stones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Possible Pharmacological Effect of Quercetin in the Management of Hyperuricemia
Quercetin, a natural flavonoid found in various fruits and vegetables, has gained attention for its potential role in managing hyperuricemia. Emerging evidence suggests that quercetin may reduce plasma uric acid levels by inhibiting xanthine oxidase, an enzyme responsible for uric acid production. Additionally, its anti-inflammatory and antioxidant properties could help mitigate the oxidative stress and inflammation associated with hyperuricemia. As a result, quercetin supplementation offers a promising avenue for therapeutic intervention in conditions like gout and other uric acid-related disorders.
Read the detailed description
In the present retrospective cross-sectional observational study, the investigators assessed the potential pharmacological effect of supplemental quercetin on the plasma uric acid levels of health adults. These participants visited nutritional clinics in Italy during the Coronavirus disease (COVID-19) pandemic for general health check-up in real-life to enhance their immune system with supplements aimed at providing additional protection against COVID-19 infection. The supplements, either quercetin or probiotic Streptococcus salivarius K12 (BLIS K12), were advised randomly to the participants for 90 days, tailored to individual needs and in the absence of any pre-defined criteria.
- Conditions
- Hyperuricemia
- Being tested
- Quevir® (Quercetin Phytosome®), Bactoblis®
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quevir® (Quercetin Phytosome®)Dietary supplement
Also called Quevir®
500 mg Quevir® (Quercetin Phytosome®) tablet
Bactoblis®Dietary supplement
Probiotic Streptococcus Salivarius K12 (ATCC BAA-1024)
| Study group | Role | What they receive |
|---|---|---|
| Supplemental Quercetin group | These participants received oral 500 mg Quevir® (Quercetin Phytosome®) tablet, twice a day for 90 days. Each Quevir® tablet contains 200 mg pure Quercetin. Receives: Dietary Supplement: Quevir® (Quercetin Phytosome®) | |
| Supplemental Probiotic Strptococcus salivarius K12 (ATCC BAA-1024) group | These participants received orally dissolving Bactoblis® tablet, once daily before bedtime for 90 days. Each Bactoblis® tablet contains at least 1x10⁹ CFU of probiotic S. salivarius K12 (ATCC BAA-1024). Receives: Dietary Supplement: Bactoblis® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma uric acid level
Supplement effect on plasma uric acid level
Measured: 90 days
Secondary outcomes (11)
Change in plasma cholesterol level
Supplement effect on plasma cholesterol level
Measured: 90 days
Change in plasma triglycerides level
Supplement effect on plasma triglycerides level
Measured: 90 days
Change in plasma glucose level
Supplement effect on plasma glucose level
Measured: 90 days
Change in plasma insulin level
Supplement effect on plasma insulin level
Measured: 90 days
Change in plasma creatine phosphokinase level
Supplement effect on plasma creatine phosphokinase level
Measured: 90 days
Change in alanine transaminase level
Supplement effect on liver function
Measured: 90 days
Change in aspartate aminotransferase level
Supplement effect on liver function
Measured: 90 days
Change in alkaline phosphatase level
Supplement effect on liver function
Measured: 90 days
Change in gamma-glutamyl transferase level
Supplement effect on liver function
Measured: 90 days
Change in bilirubin level
Supplement effect on liver function
Measured: 90 days
Incidence of side effects
Number of patients reporting 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 posted22 Oct 2024
- Study start1 Sep 2021
- Primary completion31 Dec 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Urbino Carlo Bo, Italy
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652035
- Sponsor's protocol ID
- 88_18.01.2023_QuercetinFit - A
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Pierro F, Rabbani F, Tareen M, Nigar R, Khan A, Zerbinati N, Tanda ML, Cazzaniga M, Bertuccioli A, Falasca P, Damiani G, Villanova N. Potential pharmacological effect of Quercetin Phytosome in the management of hyperuricemia: results from real-life clinical studies. Front Nutr. 2025 Feb 7;12:1519459. doi: 10.3389/fnut.2025.1519459. eCollection 2025.
PubMed 39990611
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Pharmacological Effect of Quercetin in the Management of Hyperuricemia
- ClinicalTrials.gov ID
- NCT06652035
- Acronym / sponsor ID
- 88_18.01.2023_QuercetinFit - A
- Conditions
- Hyperuricemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- The University of Urbino Carlo Bo, Italy
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 22 Oct 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.
Quercetin, a natural flavonoid found in various fruits and vegetables, has gained attention for its potential role in managing hyperuricemia. Emerging evidence suggests that quercetin may reduce plasma uric acid levels by inhibiting xanthine oxidase, an enzyme responsible for uric acid production. Additionally, its anti-inflammatory and antioxidant properties could help mitigate the oxidative stress and inflammation associated with hyperuricemia. As a result, quercetin supplementation offers a promising avenue for therapeutic intervention in conditions like gout and other uric acid-related disorders.
Detailed description
In the present retrospective cross-sectional observational study, the investigators assessed the potential pharmacological effect of supplemental quercetin on the plasma uric acid levels of health adults. These participants visited nutritional clinics in Italy during the Coronavirus disease (COVID-19) pandemic for general health check-up in real-life to enhance their immune system with supplements aimed at providing additional protection against COVID-19 infection. The supplements, either quercetin or probiotic Streptococcus salivarius K12 (BLIS K12), were advised randomly to the participants for 90 days, tailored to individual needs and in the absence of any pre-defined criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental Quercetin group | – | Dietary Supplement: Quevir® (Quercetin Phytosome®)These participants received oral 500 mg Quevir® (Quercetin Phytosome®) tablet, twice a day for 90 days. Each Quevir® tablet contains 200 mg pure Quercetin. |
| Supplemental Probiotic Strptococcus salivarius K12 (ATCC BAA-1024) group | – | Dietary Supplement: Bactoblis®These participants received orally dissolving Bactoblis® tablet, once daily before bedtime for 90 days. Each Bactoblis® tablet contains at least 1x10⁹ CFU of probiotic S. salivarius K12 (ATCC BAA-1024). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants visited the nutritional clinics during the COVID-19 pandemic for general health check up to improve their immunological protection against COVID-19 infection.
Key inclusion criteria (4 listed)
- Healthy adults
- BMI between 18.5 and 29.9 kg/m²
- Non-smoker
- Consumtion of less than 3 units of alcohol per day
Key exclusion criteria (2 listed)
- - Plasma uric acid concentrations above 7 mg/dL
- Diagnosis of endocrinological, metabolic, oncological, neurological, or bowel inflammatory disease diseases, gout, kidney stones
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 |
|---|---|---|
| Quevir® (Quercetin Phytosome®)Also: Quevir®500 mg Quevir® (Quercetin Phytosome®) tablet | Dietary supplement | Supplemental Quercetin group |
| Bactoblis®Probiotic Streptococcus Salivarius K12 (ATCC BAA-1024) | Dietary supplement | Supplemental Probiotic Strptococcus salivarius K12 (ATCC BAA-1024) group |
Primary outcome
Change in plasma uric acid level
Time frame: 90 days
Supplement effect on plasma uric acid level
11 secondary outcomes
Change in plasma cholesterol level
Time frame: 90 days
Change in plasma triglycerides level
Time frame: 90 days
Change in plasma glucose level
Time frame: 90 days
Change in plasma insulin level
Time frame: 90 days
Change in plasma creatine phosphokinase level
Time frame: 90 days
Change in alanine transaminase level
Time frame: 90 days
Change in aspartate aminotransferase level
Time frame: 90 days
Change in alkaline phosphatase level
Time frame: 90 days
Change in gamma-glutamyl transferase level
Time frame: 90 days
Change in bilirubin level
Time frame: 90 days
Incidence of side effects
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 29 Oct 2024.
- Derived from this study: PubMed 39990611Di Pierro F, Rabbani F, Tareen M, Nigar R, Khan A, Zerbinati N, Tanda ML, Cazzaniga M, Bertuccioli A, Falasca P, Damiani G, Villanova N. Potential pharmacological effect of Quercetin Phytosome in the management of hyperuricemia: results from real-life clinical studies. Front Nutr. 2025 Feb 7;12:1519459. doi: 10.3389/fnut.2025.1519459. eCollection 2025.
- 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.
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?
An observational study of 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 4 inclusion and 2 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 29 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?
Change in plasma uric acid level (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06652035, which also lists 1 linked publication.
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 29 Oct 2024.