NCT06652035

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

October 16, 2024

Last Update Submit

October 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in plasma uric acid level

    Supplement effect on plasma uric acid level

    90 days

Secondary Outcomes (11)

  • Change in plasma cholesterol level

    90 days

  • Change in plasma triglycerides level

    90 days

  • Change in plasma glucose level

    90 days

  • Change in plasma insulin level

    90 days

  • Change in plasma creatine phosphokinase level

    90 days

  • +6 more secondary outcomes

Study Arms (2)

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®)

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®

Interventions

500 mg Quevir® (Quercetin Phytosome®) tablet

Also known as: Quevir®
Supplemental Quercetin group
Bactoblis®DIETARY_SUPPLEMENT

Probiotic Streptococcus Salivarius K12 (ATCC BAA-1024)

Supplemental Probiotic Strptococcus salivarius K12 (ATCC BAA-1024) group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Buccomino Medical Clinic

Milan, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 22, 2024

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

June 15, 2023

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations