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Completed

NCT Number: NCT06591767

Quercetin as Possible Supportive Therapy for 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S. Orsola-Malpighi Polyclinic Hospital

Bologna, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quercetin

Dietary Supplement

200 mg supplemental Quercefit®

Other names: Quevir®

Berberol K®

Combination Product

Berberine Phytosome® 730 mg

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

Primary outcomes

  1. Effect on circulatory uric acid

    Time frame: 90 days

    Change in plasma uric acid level

Secondary outcomes

  1. Effect on lipids

    Time frame: 90 days

    Change in plasma cholesterol level

  2. Effect on lipids

    Time frame: 90 days

    Change in plasma triglycerides level

  3. Effect on glycemia

    Time frame: 90 days

    Change in plasma glucose level

  4. Effect on glycemia

    Time frame: 90 days

    Change in plasma insulin level

  5. Effect on body internal organs muscles

    Time frame: 90 days

    Change in the Creatine Phosphokinase (CPK) levels

  6. Effect on liver function

    Time frame: 90 days

    Change in the Alanine Aminotransferase levels

  7. Effect on liver function

    Time frame: 90 days

    Change in the Aspartate Aminotransferase levels

  8. Effect on liver function

    Time frame: 90 days

    Change in the Alkaline Phosphatase levels

  9. Effect on liver function

    Time frame: 90 days

    Change in the Gamma-Glutamyl Transferase levels

  10. Effect on liver function

    Time frame: 90 days

    Change in the Bilirubin levels

  11. Supplement safety and tolerability

    Time frame: 90 days

    Number of patients reporting possible side effects

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • University of Urbino "Carlo Bo"

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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