Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
All Genders
Healthy Volunteers
NCT06338215

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

Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2024-12-12

10000

Participants Needed

1

Research Sites

267 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males aged 50 to 70 years, females aged 55 to 75 years
  • Drinkers consuming between 3 and 40 alcoholic drinks per week
  • Projected life expectancy of more than 5 years based on physician judgment
  • Willingness to receive advice on healthier alcohol consumption for up to 4 years
Not Eligible

You will not qualify if you...

  • No access to smartphone, computer, or tablet with internet connection
  • Drinking less than 30 g or more than 400 g of pure alcohol per week
  • Illiteracy, inability or unwillingness to give written consent or communicate with study staff, or inadequate skills to use online technologies
  • Severe psychiatric conditions or diagnosis of cognitive impairment or dementia
  • Presence of liver cirrhosis or previous liver cancer
  • Diagnosis of breast cancer within the last 10 years
  • Habitual use of high-dose medications that prevent any alcohol use

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

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Research Team

M

Miguel A Martinez-Gonzalez, MD, MPH, PhD

CONTACT

M

Maira Bes-Rastrollo, PharmD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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