Possible Pharmacological Effect of Quercetin in the Management of Hyperuricemia - Results From Real-life Clinical Studies

October 27, 2024 updated by: Dr. Amjad Khan, Liaquat University of Medical & Health Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Dr. Buccomino Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Healthy adults
  • BMI between 18.5 and 29.9 kg/m²
  • Non-smoker
  • Consumtion of less than 3 units of alcohol per day

Exclusion Criteria:

  • - Plasma uric acid concentrations above 7 mg/dL
  • Diagnosis of endocrinological, metabolic, oncological, neurological, or bowel inflammatory disease diseases, gout, kidney stones

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Dietary supplement: Quevir® (Quercetin Phytosome®)
500 mg Quevir® (Quercetin Phytosome®) tablet
Other Names:
  • Quevir®
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).
Dietary supplement: Bactoblis®
Probiotic Streptococcus Salivarius K12 (ATCC BAA-1024)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in plasma uric acid level
Time Frame: 90 days
Supplement effect on plasma uric acid level
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in plasma cholesterol level
Time Frame: 90 days
Supplement effect on plasma cholesterol level
90 days
Change in plasma triglycerides level
Time Frame: 90 days
Supplement effect on plasma triglycerides level
90 days
Change in plasma glucose level
Time Frame: 90 days
Supplement effect on plasma glucose level
90 days
Change in plasma insulin level
Time Frame: 90 days
Supplement effect on plasma insulin level
90 days
Change in plasma creatine phosphokinase level
Time Frame: 90 days
Supplement effect on plasma creatine phosphokinase level
90 days
Change in alanine transaminase level
Time Frame: 90 days
Supplement effect on liver function
90 days
Change in aspartate aminotransferase level
Time Frame: 90 days
Supplement effect on liver function
90 days
Change in alkaline phosphatase level
Time Frame: 90 days
Supplement effect on liver function
90 days
Change in gamma-glutamyl transferase level
Time Frame: 90 days
Supplement effect on liver function
90 days
Change in bilirubin level
Time Frame: 90 days
Supplement effect on liver function
90 days
Incidence of side effects
Time Frame: 90 days
Number of patients reporting side effects
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liaquat University of Medical & Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Urbino Carlo Bo, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 88_18.01.2023_QuercetinFit - A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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