NCT06591767

Brief 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 associated risks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

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

October 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

September 8, 2024

Last Update Submit

October 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effect on circulatory uric acid

    Change in plasma uric acid level

    90 days

Secondary Outcomes (11)

  • Effect on lipids

    90 days

  • Effect on lipids

    90 days

  • Effect on glycemia

    90 days

  • Effect on glycemia

    90 days

  • Effect on body internal organs muscles

    90 days

  • +6 more secondary outcomes

Study Arms (3)

Quercetin group

EXPERIMENTAL

In this group hyperuricemic patients (uric acid \> 8 mg/dL) received oral supplemental Quercetin, twice a day for 90 days.

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.

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.

Combination Product: Berberol K®

Interventions

QuercetinDIETARY_SUPPLEMENT

200 mg supplemental Quercefit®

Also known as: Quevir®
Quercetin group
Berberol K®COMBINATION_PRODUCT

Berberine Phytosome® 730 mg \+ MonakoPure® containing 2.9 mg of monacolin K and KA from red yeast rice extract

Control group 1Control group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Current use of uric acid-lowering medications (e.g., allopurinol, febuxostat).
  • Diagnosed with oncological diseases.
  • Diagnosed with neurological diseases.
  • Diagnosed with inflammatory bowel diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S. Orsola-Malpighi Polyclinic Hospital

Bologna, Italy

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

First Submitted

September 8, 2024

First Posted

September 19, 2024

Study Start

October 1, 2023

Primary Completion

April 30, 2024

Study Completion

August 31, 2024

Last Updated

October 17, 2024

Record last verified: 2024-10

Locations