Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT06652035
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2024-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Possible Pharmacological Effect of Quercetin in the Management of Hyperuricemia - Results From Real-life Clinical Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-27', 'studyFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2024-10-20', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma uric acid level', 'timeFrame': '90 days', 'description': 'Supplement effect on plasma uric acid level'}], 'secondaryOutcomes': [{'measure': 'Change in plasma cholesterol level', 'timeFrame': '90 days', 'description': 'Supplement effect on plasma cholesterol level'}, {'measure': 'Change in plasma triglycerides level', 'timeFrame': '90 days', 'description': 'Supplement effect on plasma triglycerides level'}, {'measure': 'Change in plasma glucose level', 'timeFrame': '90 days', 'description': 'Supplement effect on plasma glucose level'}, {'measure': 'Change in plasma insulin level', 'timeFrame': '90 days', 'description': 'Supplement effect on plasma insulin level'}, {'measure': 'Change in plasma creatine phosphokinase level', 'timeFrame': '90 days', 'description': 'Supplement effect on plasma creatine phosphokinase level'}, {'measure': 'Change in alanine transaminase level', 'timeFrame': '90 days', 'description': 'Supplement effect on liver function'}, {'measure': 'Change in aspartate aminotransferase level', 'timeFrame': '90 days', 'description': 'Supplement effect on liver function'}, {'measure': 'Change in alkaline phosphatase level', 'timeFrame': '90 days', 'description': 'Supplement effect on liver function'}, {'measure': 'Change in gamma-glutamyl transferase level', 'timeFrame': '90 days', 'description': 'Supplement effect on liver function'}, {'measure': 'Change in bilirubin level', 'timeFrame': '90 days', 'description': 'Supplement effect on liver function'}, {'measure': 'Incidence of side effects', 'timeFrame': '90 days', 'description': 'Number of patients reporting side effects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperuricemia']}, 'referencesModule': {'references': [{'pmid': '39990611', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'In the present retrospective cross-sectional observational study, the investigators assessed the potential pharmacological effect of supplemental quercetin on the plasma uric acid levels of health adults. These participants visited nutritional clinics in Italy during the Coronavirus disease (COVID-19) pandemic for general health check-up in real-life to enhance their immune system with supplements aimed at providing additional protection against COVID-19 infection. The supplements, either quercetin or probiotic Streptococcus salivarius K12 (BLIS K12), were advised randomly to the participants for 90 days, tailored to individual needs and in the absence of any pre-defined criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n* BMI between 18.5 and 29.9 kg/m²\n* Non-smoker\n* Consumtion of less than 3 units of alcohol per day\n\nExclusion Criteria:\n\n* \\- Plasma uric acid concentrations above 7 mg/dL\n* Diagnosis of endocrinological, metabolic, oncological, neurological, or bowel inflammatory disease diseases, gout, kidney stones'}, 'identificationModule': {'nctId': 'NCT06652035', 'briefTitle': 'Possible Pharmacological Effect of Quercetin in the Management of Hyperuricemia - Results From Real-life Clinical Studies', 'organization': {'class': 'OTHER', 'fullName': 'Liaquat University of Medical & Health Sciences'}, 'officialTitle': 'Possible Pharmacological Effect of Quercetin in the Management of Hyperuricemia', 'orgStudyIdInfo': {'id': '88_18.01.2023_QuercetinFit - A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Supplemental Quercetin group', 'description': 'These participants received oral 500 mg Quevir® (Quercetin Phytosome®) tablet, twice a day for 90 days. Each Quevir® tablet contains 200 mg pure Quercetin.', 'interventionNames': ['Dietary Supplement: Quevir® (Quercetin Phytosome®)']}, {'label': 'Supplemental Probiotic Strptococcus salivarius K12 (ATCC BAA-1024) group', 'description': '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).', 'interventionNames': ['Dietary Supplement: Bactoblis®']}], 'interventions': [{'name': 'Quevir® (Quercetin Phytosome®)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Quevir®'], 'description': '500 mg Quevir® (Quercetin Phytosome®) tablet', 'armGroupLabels': ['Supplemental Quercetin group']}, {'name': 'Bactoblis®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic Streptococcus Salivarius K12 (ATCC BAA-1024)', 'armGroupLabels': ['Supplemental Probiotic Strptococcus salivarius K12 (ATCC BAA-1024) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Dr. Buccomino Medical Clinic', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaquat University of Medical & Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Urbino Carlo Bo, Italy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Biochemistry and Experimental Medicine', 'investigatorFullName': 'Dr. Amjad Khan', 'investigatorAffiliation': 'Liaquat University of Medical & Health Sciences'}}}}