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Search / Trial NCT06338215

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

Launched by CLINICA UNIVERSIDAD DE NAVARRA, UNIVERSIDAD DE NAVARRA · Mar 26, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Alcohol Drinking Pattern Abstention Advice Clinical Trial Moderation Mediterranean Alcohol Drinking Pattern

ClinConnect Summary

This clinical trial is studying the effects of two different types of advice about alcohol consumption on health outcomes, specifically focusing on whether moderate drinking is as safe as not drinking at all. The researchers want to find out if following a Mediterranean Alcohol Drinking Pattern—where people drink in moderation, avoid binge drinking, and prefer red wine—can help prevent serious health problems like heart disease, cancer, and diabetes, as well as overall death rates. The study will involve over 10,000 Spanish adults aged 50 and older.

To participate, men must be between 50 and 70 years old, and women between 55 and 75 years old. Eligible participants should currently drink alcohol and have a life expectancy of more than five years. During the four-year study, participants will receive guidance on how to drink healthier. It's important to note that those who do not have access to the internet, who drink too little or too much alcohol, or who have certain health issues like severe psychiatric conditions or liver problems, won't be able to join the trial. Overall, this study aims to provide valuable insights into how different drinking habits can impact long-term health.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Males aged 50-70 years, Women aged 55-75 years
  • 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:
  • 1. Participants without smartphone or a computer (or tablet) with Internet connection.
  • 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).
  • 7. Patients under habitual use of high-dose medications that completely preclude any use of alcohol. Most of these patients will be already excluded by the second or fourth exclusion criteria.

About Clinica Universidad De Navarra, Universidad De Navarra

Clinica Universidad de Navarra, affiliated with Universidad de Navarra, is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and patient care. With a commitment to excellence, it integrates cutting-edge medical research with comprehensive clinical services, fostering an environment that promotes the development of new therapies and treatment protocols. The institution is recognized for its robust clinical trial programs, which aim to enhance patient outcomes and contribute to the global medical community's knowledge. Through collaboration with various research entities and a focus on ethical standards, Clinica Universidad de Navarra plays a pivotal role in translating scientific discoveries into practical applications in medicine.

Locations

Pamplona, Navarra, Spain

Patients applied

0 patients applied

Trial Officials

Miguel A Martinez-Gonzalez, MD, MPH, PhD

Principal Investigator

University of Navarra

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported