Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-27 @ 6:42 PM
Study NCT ID:
NCT06286657
Status:
RECRUITING
Last Update Posted:
2025-04-15
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Xanthohumol and Viral Infections (XL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C104536', 'term': 'xanthohumol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in severity and duration of viral infections', 'timeFrame': '90 days', 'description': 'Changes in score of Wisconsin Upper Respiratory Symptom Survey'}], 'secondaryOutcomes': [{'measure': 'Changes in blood lipid levels', 'timeFrame': '90 days', 'description': 'Changes in triglyceride levels (mg/dl) and cholesterol levels (mg/dl)'}, {'measure': 'Changes in cognitive skills', 'timeFrame': '90 days', 'description': 'Assessment of cognitive processes using stroop test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection Viral']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to determine if a regular oral supplementation of xanthohumol attenuate the severity of symptoms and duration of´viral infections.', 'detailedDescription': 'In this placebo-controlled study, blood is taken on the first day of the study, followed by a 90-day intervention with xanthohumol or a placebo, which is taken twice daily. Blood samples will be taken on day 0, day 45 and day 90. Should the study participants develop a respiratory infection during the study, they will be asked to perform a self-test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n* BMI \\>18 kg/m² or \\< 28kg/m²\n\nExclusion Criteria:\n\n* food intolerances\n* food allergies\n* chronic inflammatory diseases\n* metabolic diseases\n* viral or bacterial infections within the last 3 weeks of inclusion\n* intake of immunosuppressive medication\n* severe acute respiratory syndrome coronavirus type 2-infection in the last 4 months\n* influenza infection in the "current" flu season'}, 'identificationModule': {'nctId': 'NCT06286657', 'briefTitle': 'Xanthohumol and Viral Infections (XL)', 'organization': {'class': 'OTHER', 'fullName': 'University of Vienna'}, 'officialTitle': 'Xanthohumol in the Prevention of Virus-mediated Upper Respiratory Tract Infections in Humans', 'orgStudyIdInfo': {'id': 'UVienna23a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants consume twice per day a study drink which contains 0,75 mg soluble Xanthohumol for 90 days', 'interventionNames': ['Dietary Supplement: Xanthohumol']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Participants consume twice per day a study drink which contains 0 mg soluble Xanthohumol for 90 days', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Xanthohumol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants consume twice per day a study drink which contains 0,75 mg soluble Xanthohumol for 90 days', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants consume twice per day a study drink which contains 0 mg soluble Xanthohumol for 90 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Ina Bergheim, Prof. Dr.', 'role': 'CONTACT', 'email': 'ina.bergheim@univie.ac.at', 'phone': '+43-1-4277-54981'}], 'facility': 'University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Ina Bergheim, Prof. Dr.', 'role': 'CONTACT', 'email': 'ina.bergheim@univie.ac.at', 'phone': '+43-1-4277-54981'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Ina Bergheim', 'investigatorFullName': 'Prof. Dr. Ina Bergheim', 'investigatorAffiliation': 'University of Vienna'}}}}