Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05261620
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2021-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wine Implementation for Surgical Recovery Enhancement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2022-02-20', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants consuming red wine after surgery showing improved health perception status assessed with the Mental Health Index (MHI) of the Short Form-36 Health Survey questionnaire', 'timeFrame': '30 days', 'description': 'Health perception status measured using the Mental Health Index (MHI) of the Short Form-36 Health Survey'}], 'secondaryOutcomes': [{'measure': 'Number of Participants consuming red wine With post-operative complications assessed with Clavien-Dindo classification', 'timeFrame': '30 days', 'description': 'Rate of post-operative complications according to Clavien-Dindo classification'}, {'measure': 'Number of Participants consuming red wine experiencing hospital readmissions after surgery', 'timeFrame': '30 days', 'description': 'Rate of hospital readmissions from surgery'}, {'measure': 'Number of male Participants consuming red wine with change in sexual perceptions after surgery using IIEF questionnaire', 'timeFrame': '30 days', 'description': 'To evaluate changes in sexual perceptions after surgery using IIEF questionnaire'}, {'measure': 'Number of Participants consuming red wine with a change in blood oxidative stress markers assessed using ORAC (Oxygen Radical Absorbance Capacity) tests', 'timeFrame': '30 days', 'description': 'Oxidative stress will be assessed using ORAC (Oxygen Radical Absorbance Capacity) tests.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life']}, 'referencesModule': {'references': [{'pmid': '22540046', 'type': 'BACKGROUND', 'citation': 'Kim SJ, Kim DJ. 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Epub 2017 Jul 25.'}, {'pmid': '24631946', 'type': 'BACKGROUND', 'citation': 'Turati F, Galeone C, Rota M, Pelucchi C, Negri E, Bagnardi V, Corrao G, Boffetta P, La Vecchia C. Alcohol and liver cancer: a systematic review and meta-analysis of prospective studies. Ann Oncol. 2014 Aug;25(8):1526-35. doi: 10.1093/annonc/mdu020. Epub 2014 Mar 14.'}, {'pmid': '25422909', 'type': 'BACKGROUND', 'citation': 'Bagnardi V, Rota M, Botteri E, Tramacere I, Islami F, Fedirko V, Scotti L, Jenab M, Turati F, Pasquali E, Pelucchi C, Galeone C, Bellocco R, Negri E, Corrao G, Boffetta P, La Vecchia C. Alcohol consumption and site-specific cancer risk: a comprehensive dose-response meta-analysis. Br J Cancer. 2015 Feb 3;112(3):580-93. doi: 10.1038/bjc.2014.579. Epub 2014 Nov 25.'}, {'pmid': '27156220', 'type': 'BACKGROUND', 'citation': 'Gubner NR, Delucchi KL, Ramo DE. Associations between binge drinking frequency and tobacco use among young adults. 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BJU Int. 2006 Feb;97(2):274-8. doi: 10.1111/j.1464-410X.2005.05893.x.'}]}, 'descriptionModule': {'briefSummary': 'This is a monocenter, prospective randomized clinical trial. The study aims to investigate whether moderate consumption of red wine (1 unit at lunch and 1 unit at dinner) for 30 days after surgery could improve the quality of life (QoL) and health perception status of the patient, without increasing the morbidity and the toxicity related to the surgery.', 'detailedDescription': 'Participants are randomized to receive either the standard of care (SoC - no alcohol assumption) (Control Arm) or the standard of care plus wine-controlled intake (Experimental Arm). All participants are candidates for surgery and habitual consumers of alcohol-containing beverages (7-21 alcohol-containing beverages per week) with a body mass index between 18 and 30 kg/m2.\n\nControl Arm subjects adhere to diet free of any alcohol-containing beverages, as normally recommended by surgeons in their clinical practice.\n\nSubjects assigned to the Experimental Arm adhere to usual diet, but were instructed to "Western prudent" dietary principles of the Lyon Diet Heart study, which is the reference in terms of cardiovascular protection, to avoid supplementation of multivitamin, minerals or probiotics, to not drink more than 2 cups of coffee, black or green tea per day and to supervise the intake of food rich in phenolic compounds through providing a list of suggested foods. Subjects will be randomly assigned to consume exclusively during meals one glass (around 150 ml at lunch and 150 ml at dinner) of red wine containing ethanol (˜13% EtOH v/v) with a high content of phenolic compounds (800 mg of Gallic acid equivalent) both for woman and men. Total polyphenolic contents and antioxidant activity (Folin-Ciocalteu method with calibration curve in gallic acid), antioxidant/radical scavenger capacity \\[DPPH (2,2-diphenyl-1-picrylhydrazyl) test\\] and phenolic profiles \\[HPLC (High Performance Liquid Chromatography)/DAD (diode-array detector) /ESI-MS (Electrospray Ionisation Mass Spectrometry) analysis\\] will be performed for wine selection for the clinical trial. The wine administered for the study purposes will be chosen from a series of wines that will be proposed by the sponsor of the study. The wine with the best polyphenolic and antioxidant properties will be chosen to be administered to the enrolled patients.\n\nFor both randomized groups, SoC plus W.I.S.E and SoC only, in order to assess participant\'s alcohol consumption, a trained psychologist will administer the AUDIT questionnaire specific for alcoholic drinks and a qualitative interview to patients. Frequency of intake is scheduled and each participant will be allowed to drink up to a single unit of wine at lunch and a single unit of red wine at dinner per day from the first post-operative day, during all the hospital stay, and for the next 30 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years-old or older\n* Candidate to surgery\n* Willing to follow the protocol\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe Chronic Kidney Disease (eGFR\\<30)\n* Severe liver disease (Child-Pugh B or C)\n* Severe heart failure (NYHA Classes III-IV)\n* body mass index lower than 18 or higher than 30 kg/m2\n* Pregnant woman\n* Teetotal subjects\n* History of alcohol abuse evaluated through AUDIT questionnaire and qualitative interview by a psychologist\n* Higher than moderate alcohol intake consumers (more than 25 g of alcohol per day for women and 40 g of alcohol per day for men)\n* Type I diabetes\n* Severe respiratory diseases like chronic obstructive pulmonary disease (GOLD classes III-IV)\n* Neurological diseases such as Alzheimer's, Parkinson's, fibromyalgia or multiple sclerosis."}, 'identificationModule': {'nctId': 'NCT05261620', 'acronym': 'WISE', 'briefTitle': 'Wine Implementation for Surgical Recovery Enhancement', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'W.I.S.E.-Wine Implementation for Surgical Recovery Enhancement', 'orgStudyIdInfo': {'id': 'WISE trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SoC + WISE', 'description': 'Candidates for surgery and habitual consumers of alcohol-containing beverages (7-21 alcohol-containing beverages per week) with a body mass index between 18 and 30 kg/m2. Subjects assigned to the Experimental Arm will be assigned to consume exclusively during meals one glass (around 150 ml at lunch and 150 ml at dinner) of red wine containing ethanol (˜13% EtOH v/v) with a high content of phenolic compounds (800 mg of Gallic acid equivalent).', 'interventionNames': ['Dietary Supplement: red wine']}, {'type': 'NO_INTERVENTION', 'label': 'SoC', 'description': 'Control Arm subjects adhere to diet free of any alcohol-containing beverages, as normally recommended by surgeons in their clinical practice'}], 'interventions': [{'name': 'red wine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects in the intervention arm (SoC+WISE) will be assigned to consume exclusively during meals one glass (around 150 ml at lunch and 150 ml at dinner) of red wine containing ethanol (˜13% EtOH v/v) with a high content of phenolic compounds (800 mg of Gallic acid equivalent) both for woman and men. Total polyphenolic contents and antioxidant activity (Folin-Ciocalteu method with calibration curve in gallic acid), antioxidant/radical scavenger capacity \\[DPPH (2,2-diphenyl-1-picrylhydrazyl) test\\] and phenolic profiles \\[HPLC (High Performance Liquid Chromatography)/DAD (diode-array detector) /ESI-MS (Electrospray Ionisation Mass Spectrometry) analysis\\] will be performed for wine selection for the clinical trial.', 'armGroupLabels': ['SoC + WISE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'facility': 'Umberto Capitanio', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Kidney Tumor Research Unit', 'investigatorFullName': 'Umberto Capitanio', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}