- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06652035
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
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Milano, Italy
- Dr. Buccomino Medical Clinic
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
500 mg Quevir® (Quercetin Phytosome®) tablet
Other Names:
|
|
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).
|
Probiotic Streptococcus Salivarius K12 (ATCC BAA-1024)
|
What is the study measuring?
Primary Outcome Measures
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
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
|
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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.
Collaborators
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)
September 1, 2021
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
June 15, 2023
Study Registration Dates
First Submitted
October 16, 2024
First Submitted That Met QC Criteria
October 20, 2024
First Posted (Actual)
October 22, 2024
Study Record Updates
Last Update Posted (Actual)
October 29, 2024
Last Update Submitted That Met QC Criteria
October 27, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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