Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
NCT ID: NCT06338215
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
10000 participants
INTERVENTIONAL
2024-05-15
2029-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Moderation
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.
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:
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.
Abstention
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
Advice on alcohol abstention.
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:
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.
Abstention
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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:
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.
Abstention
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Drinkers of any alcoholic beverage initially consuming 3 or more but 40 or less drinks/wk
* Projected life expectancy more than 5 years (according to the judgment of their attending physician)
* Willing to receive advice during up to 4 years on how to improve their alcohol intake making it healthier
Exclusion Criteria
2. Drinkers of less than 30 g of pure alcohol/wk or more than 400 g of pure alcohol/wk
3. Illiteracy, inability/unwillingness to give written consent or communicate with study staff, or inadequate abilities for the use of on-line technologies
4. Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia.
5. Participants with liver cirrhosis or prior liver cancer.
6. Patients with a recent diagnosis of breast cancer (diagnosed in the last 10 years).
50 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Miguel A Martinez-Gonzalez, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Navarra
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Navarra
Pamplona, Navarre, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Estíbaliz Goñi, Nutritionist
Role: primary
Rafael Perez-Araluce, PharmD
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Martinez-Gonzalez MA. Should we remove wine from the Mediterranean diet?: a narrative review. Am J Clin Nutr. 2024 Feb;119(2):262-270. doi: 10.1016/j.ajcnut.2023.12.020. Epub 2023 Dec 28.
Martinez-Gonzalez MA, Hernandez Hernandez A. Effect of the Mediterranean diet in cardiovascular prevention. Rev Esp Cardiol (Engl Ed). 2024 Jul;77(7):574-582. doi: 10.1016/j.rec.2024.01.006. Epub 2024 Feb 7. English, Spanish.
Barberia-Latasa M, Bes-Rastrollo M, Perez-Araluce R, Martinez-Gonzalez MA, Gea A. Mediterranean Alcohol-Drinking Patterns and All-Cause Mortality in Women More Than 55 Years Old and Men More Than 50 Years Old in the "Seguimiento Universidad de Navarra" (SUN) Cohort. Nutrients. 2022 Dec 14;14(24):5310. doi: 10.3390/nu14245310.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
101097681
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UNATI_2024
Identifier Type: -
Identifier Source: org_study_id