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Advice about alcohol intake following a Mediterranean Alcohol Drinking Pattern: Moderation (7 or less drinks/wk in women and 14 or less drinks/wk in men), avoidance of binge drinking, consumption of alcohol with meals and preference for red wine.

Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months.

Goals of intervention:

1. moderate consumption (7 or less drinks/wk for women, 14 or less drinks/wk for men) of red wine (a drink=150 ml).
2. always during meals
3. spread out throughout the whole week, and
4. avoidance of binge-drinking episodes. No participant will be invited to start or increase his/her alcohol intake.

Moderate Alcohol Drinking Pattern

Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months.

Goals of intervention:

Abstention. Message of 0 alcohol.

Abstention

Miguel A Martinez-Gonzalez, MD, MPH, PhD

Maira Bes-Rastrollo, PharmD, PhD

Estíbaliz Goñi, Nutritionist

Rafael Perez-Araluce, PharmD

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.

Policymakers and clinicians are currently perplexed on how to reduce alcohol harms in drinkers, because of contradictory guidelines: abstention is proposed as the healthiest option by many health advocates, stating that "there is no safe level of alcohol intake"; but most nonrandomized studies found lower all-cause mortality and other beneficial outcomes in moderate drinkers than in abstainers among subjects \&amp;gt;50 years. However, potential biases may compromise these latter studies, particularly when effects are null or moderate. A large pragmatic randomized controlled trial (RCT) of realistic advice aimed to change behaviour addressing clinical endpoints is long overdue. It will provide first-level evidence to confront the harms of one of the most widely used substances by humankind.

The European Research Council has funded, through an Advanced Research Grant (2023-2028) to the University of Navarra (Spain), as Host Institution, a 4-year non-inferiority RCT with more than 10,000 drinkers (men 50-70 years or women 55-75 years consuming 3 or more but 40 or less drinks/wk). The name of the trial is UNATI (University of Navarra Alumni Trialist Initiative).

At least ten thousand drinkers will be randomized in a 1:1 ratio to repeatedly (4 contacts/year) receive during 4 years two different advices:

1. abstention;
2. moderation (7 or less drinks/wk in women and 14 or less drinks/wk in men), avoidance of binge drinking, with preference for red wine consumed always with meals, and consumption spread out throughout the week, following the traditional Mediterranean Alcohol Drinking Pattern (MADP). Moderate consumption is hypothesized to be non-inferior. No initiation or increment in alcohol intake will be promoted.

The primary endpoint will be a global index of all-cause mortality, cardiovascular events, any invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, injury requiring hospital admission or tuberculosis or other infections requiring hospitalization. As a secondary analysis, the most severe outcomes (mortality, invasive cancer, stroke, myocardial infarction, liver cirrhosis) will be considered independently with sufficient priority over less severe outcomes, using ad hoc methods.

The UNATI trial will provide for the first time an evidence-based answer to a question of the utmost interest in clinical medicine, given the high prevalence of moderate alcohol intake, and the current situation of equipoise with opposing views in the scientific community on the most sensible advice for moderate drinkers. The starting date for the project is December 1, 2023. The randomization of participants will start on June 2024.

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

A Non-inferiority Randomized Trial Testing an Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality

The generated dataset (completely anonymized) will be made available to every proficient researcher who may present a relevant research proposal to the Steering Committee for further exploitation of the data upon all the usual legal precautions for the protection of individual data will be respected.

The trial may not be long enough to observe effects on cancer endpoints. Therefore, a comparison between groups of cancer incidence endpoints after 10-year follow-up, assessed through the information on clinical records, will be included as an ancillary analysis.

Global index of all-cause mortality, cardiovascular events, any invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, injury requiring hospital admission, tuberculosis or other infections requiring hospitalization evaluated from the information on clinical records.

The most severe outcomes (mortality, invasive cancer, stroke, myocardial infarction, liver cirrhosis) will be considered independently with sufficient priority over less sever outcomes, using ad hoc methods, using information on clinical records.

Clinica Universidad de Navarra, Universidad de Navarra

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality	NCT06338215	All Cause Morta... Cardiovascular ... Invasive Cancer Liver Cirrhosis Type 2 Diabetes Depression Dementia Injury Traumati... Tuberculosis Infections	Moderate Alcoho... Abstention	50 Years - 75 Years	Clinica Universidad de Navarra, Universidad de Navarra
Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality	NCT06338215	All Cause Morta... Cardiovascular ... Invasive Cancer Liver Cirrhosis Type 2 Diabetes Depression Dementia Injury Traumati... Tuberculosis Infections	Moderate Alcoho... Abstention	50 Years - 75 Years	Clinica Universidad de Navarra, Universidad de Navarra

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