A large randomized trial assessing alcohol cessation versus moderation on clinical events: UNATI.

The health effects of moderate alcohol consumption remain a highly debated topic in public health and epidemiology. While observational studies have suggested a possible protective effect of moderate drinking, particularly within Mediterranean patterns, concerns about confounding and selection bias persist. No randomized trial to date has definitively addressed whether alcohol cessation offers superior health benefits compared to sustained moderate drinking. In response to this evidence gap, the European Research Council has funded the University of Navarra Alumni Trialist Initiative (UNATI), a large, pragmatic, randomized controlled trial designed to assess the long-term effects of two behavioral interventions: complete alcohol cessation versus moderated consumption following a Mediterranean pattern. UNATI will enroll over 10,000 adults in Spain (men aged 50-70 and women aged 55-75) who currently consume alcohol regularly. Participants will be randomly assigned to one of the two interventions for four years, with annual clinical evaluations and lifestyle assessments. The trial's hybrid design-combining centralized coordination with a network of regional medical professionals-offers a unique opportunity to generate high-quality causal evidence in a real-world setting. If successful, UNATI could become a landmark study, helping to resolve a decades-long controversy regarding moderate alcohol use and health.