protocolSection identificationModule nctId: NCT06338215, orgStudyIdInfo id: UNATI_2024, secondaryIdInfos id: 101097681, type: OTHER_GRANT, domain: European Research Council, briefTitle: Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality, acronym: UNATI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Clinica Universidad de Navarra, Universidad de Navarra, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years).The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes.Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine.Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases., conditionsModule conditions: All Cause Mortality, conditions: Cardiovascular Diseases, conditions: Invasive Cancer, conditions: Liver Cirrhosis, conditions: Type 2 Diabetes, conditions: Depression, conditions: Dementia, conditions: Injury Traumatic, conditions: Tuberculosis, conditions: Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Moderate Alcohol Drinking Pattern, interventions name: Abstention, outcomesModule primaryOutcomes measure: Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases, secondaryOutcomes measure: Comparison between groups of the incidence of the most severe outcomes, otherOutcomes measure: Comparison between groups of invasive cancer incidence with extended follow-up, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Navarra, city: Pamplona, state: Navarra, zip: 31008, country: Spain, contacts name: Estíbaliz Goñi, Nutritionist, role: CONTACT, phone: 34948425600, phoneExt: 80-6596, email: egonioch@unav.es, contacts name: Rafael Perez-Araluce, PharmD, role: CONTACT, phone: +34948425600, phoneExt: 80-6672, email: rperez.21@alumni.unav.es, contacts name: Miguel A Martinez-Gonzalez, MD, MPH, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.81687, lon: -1.64323, hasResults: False