Quercetin as Possible Supportive Therapy for Mild to Moderate Hyperuricemia

Potential Pharmacological Effects of Supplemental Quercetin in the Management of Mild to Moderate Hyperuricemia

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.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia
• Intervention / Treatment: Dietary supplement: Quercetin; Combination product: Berberol K®

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • S. Orsola-Malpighi Polyclinic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quercetin group; In this group hyperuricemic patients (uric acid > 8 mg/dL) received oral supplemental Quercetin, twice a day for 90 days.	Dietary supplement: Quercetin; 200 mg supplemental Quercefit®; Other Names: Quevir®
Active Comparator: 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.	Combination product: Berberol K®; Berberine Phytosome® 730 mg + MonakoPure® containing 2.9 mg of monacolin K and KA from red yeast rice extract
Active Comparator: 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.	Combination product: Berberol K®; Berberine Phytosome® 730 mg + MonakoPure® containing 2.9 mg of monacolin K and KA from red yeast rice extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on circulatory uric acid	Change in plasma uric acid level	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on lipids	Change in plasma cholesterol level	90 days
Effect on lipids	Change in plasma triglycerides level	90 days
Effect on glycemia	Change in plasma glucose level	90 days
Effect on glycemia	Change in plasma insulin level	90 days
Effect on body internal organs muscles	Change in the Creatine Phosphokinase (CPK) levels	90 days
Effect on liver function	Change in the Alanine Aminotransferase levels	90 days
Effect on liver function	Change in the Aspartate Aminotransferase levels	90 days
Effect on liver function	Change in the Alkaline Phosphatase levels	90 days
Effect on liver function	Change in the Gamma-Glutamyl Transferase levels	90 days
Effect on liver function	Change in the Bilirubin levels	90 days
Supplement safety and tolerability	Number of patients reporting possible side effects	90 days

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: University of Urbino "Carlo Bo"

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: September 8, 2024
• First Submitted That Met QC Criteria: September 8, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Quercetin
• Other Study ID Numbers: 88_18.01.2023_QuercetinFit

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No