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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Spain
University of Navarra
RECRUITING
Pamplona
Contact Information
Primary
Miguel A Martinez-Gonzalez, MD, MPH, PhD
mamartinez@unav.es
+34948425600
Backup
Maira Bes-Rastrollo, PharmD, PhD
mbes@unav.es
+34948425600
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 10000
Treatments
Experimental: 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.
Active_comparator: Abstention
Advice on alcohol abstention.
Sponsors
Leads: Clinica Universidad de Navarra, Universidad de Navarra

This content was sourced from clinicaltrials.gov