Quercetin as Possible Supportive Therapy for Mild to Moderate Hyperuricemia

NCT ID: NCT06591767

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-08-31

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.

Detailed Description

Uric acid, a metabolic byproduct of purine degradation in humans, is a significant risk factor for the development of gout and type 2 diabetes. Supplementation with quercetin, a flavonol not naturally produced by the human body, has been shown to significantly reduce plasma uric acid levels in individuals with mild hyperuricemia. This effect is primarily achieved through the inhibition of xanthine oxidoreductase, an enzyme crucial to uric acid production.

Quercetin is the most abundant polyphenol found in fruits and vegetables and is widely used as a dietary supplement to boost the immune system and promote overall health. It is characterized by three key properties: antioxidant, anti-inflammatory, and immunomodulatory. These combined actions make quercetin a promising candidate for supporting various health conditions where oxidative stress, inflammation, and immune function play a role, including cardiovascular health, healthy aging, bone and joint health, sports and physical activity, gut health, and respiratory well-being.

The above-described properties of quercetin prompted investigators to explore its potential uricosuric therapeutic effect in two clinical studies. The first study will assess this effect in a retrospective cohort of COVID-19 patients who received quercetin as a supplemental therapy. In the second study, its potential uricosuric therapeutic effect will be assessed in a randomized controlled prospective clinical trial involving patients with mild to moderate hyperuricemia.

Conditions

Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Quercetin group

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

Group Type: EXPERIMENTAL

Quercetin

Intervention Type: DIETARY_SUPPLEMENT

200 mg supplemental Quercefit®

Control group 1

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

Group Type: ACTIVE_COMPARATOR

Berberol K®

Intervention Type: COMBINATION_PRODUCT

Berberine Phytosome® 730 mg

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

Control group 2

In this group normouricemic patients (uric acid \< 7 mg/dL) received oral supplemental Berberine and monacolins based supplement, twice a day for 90 days.

Group Type: ACTIVE_COMPARATOR

Berberol K®

Intervention Type: COMBINATION_PRODUCT

Berberine Phytosome® 730 mg

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

Interventions

Quercetin

200 mg supplemental Quercefit®

Intervention Type: DIETARY_SUPPLEMENT

Berberol K®

Berberine Phytosome® 730 mg

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Quevir®

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Urbino "Carlo Bo"

OTHER

Sponsor Role: collaborator

Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

S. Orsola-Malpighi Polyclinic Hospital

Bologna, , Italy

Countries

Italy

Other Identifiers

88_18.01.2023_QuercetinFit

Identifier Type: -

Identifier Source: org_study_id