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Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality

Study acronym: UNATI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2024 to May 15, 2024
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Clinica Universidad de Navarra, Universidad de Navarra
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and 2 more diseases
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.
Trial Details
NCT Number NCT06338215
Lead Sponsor Clinica Universidad de Navarra, Universidad de Navarra
Conditions
(from sponsor)		 All Cause Mortality, Cardiovascular Diseases, Invasive Cancer, Liver Cirrhosis, Type 2 Diabetes, Depression, Dementia, Injury Traumatic +2 more
Related terms Cardiovascular Diseases, Dementia, Depression, Diabetes Mellitus, Type 2, Infections, Liver Cirrhosis, Tuberculosis, Wounds and Injuries
Enrollment 10,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov