Should we remove wine from the Mediterranean diet?: a narrative review.
Miguel A Martínez-González
https://pubmed.ncbi.nlm.nih.gov/38157987Actively Recruiting
Phase Not Applicable
Age: 50Years - 75Years
All Genders
Healthy Volunteers
ID06338215
A Non-inferiority Randomized Trial Testing Advice on Moderate Drinking Pattern Versus 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different advice approaches on alcohol drinking in more than 10,000 Spanish adult drinkers aged 50 or older for men and 55 or older for women. The study aims to compare whether following a moderate alcohol drinking pattern, specifically the Mediterranean Alcohol Drinking Pattern (MADP), is not worse than abstaining from alcohol in preventing all-cause mortality and other chronic diseases such as cardiovascular disease, cancer, type 2 diabetes, depression, dementia, and infections. This large, randomized trial addresses the ongoing debate about alcohol consumption and health risks in older adults. Participants will be randomly assigned to one of two groups for four years. One group will receive advice to follow the MADP, which includes moderate alcohol consumption (7 or fewer drinks per week for women and 14 or fewer for men), avoiding binge drinking, preferring red wine consumed with meals, and spreading intake throughout the week. The other group will receive advice to abstain from alcohol. Both groups will receive support through quarterly remote sessions with specialized coaches, including psychologists and dietitians, involving small group meetings, personal interviews, and educational videos. During the study, participants will have four contacts per year for up to four years to receive their assigned advice and support. Researchers will monitor the incidence of a combined index of health outcomes including mortality, cardiovascular events, invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, serious injuries, and infections requiring hospitalization. Safety and adherence will be tracked through these regular contacts and assessments. The study's main measurement is the comparison of these health outcomes between the two groups over the intervention period.
CONDITIONS
Brief 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
You may qualify if you...
- Males aged 50-70 years, women aged 55-75 years
- Drinkers consuming between 3 and 40 alcoholic drinks per week
- Projected life expectancy of more than 5 years according to their attending physician
- Willing to receive advice on improving alcohol consumption for up to 4 years
You will not qualify if you...
- No access to a smartphone, computer, or tablet with Internet
- Drinkers consuming 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 for using online technologies
- Severe psychiatric conditions, cognitive impairment, or dementia
- History of liver cirrhosis or prior liver cancer
- Recent diagnosis of breast cancer within the last 10 years
- Use of high-dose medications that fully prevent any alcohol use, usually excluded by other criteria
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Treatment
Duration - Up to 4 years
Participants receive advice on alcohol consumption through quarterly contacts over 4 years by specialized coaches to promote behavior change, either following a moderate drinking pattern or abstention.
4 contacts per year (remote small group sessions and personal interviews)
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
M
Maira Bes-Rastrollo, PharmD, PhD
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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Published Research Related To This Trial
Effect of the Mediterranean diet in cardiovascular prevention.
Miguel Á Martínez-González, Aitor Hernández Hernández
https://pubmed.ncbi.nlm.nih.gov/38336153Mediterranean 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.
María Barbería-Latasa, Maira Bes-Rastrollo, Rafael Pérez-Araluce...
https://pubmed.ncbi.nlm.nih.gov/36558468