Clinical trial · Interventional
Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
A Non-inferiority Randomized Trial Testing an Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| All Cause Mortality | — | UNRESOLVED | — |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Dementia | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Infections | — | UNRESOLVED | — |
| Injury Traumatic | — | UNRESOLVED | — |
| Invasive Cancer | Invasive Malignant Neoplasm | ALIAS | 0.90 |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Tuberculosis | — | UNRESOLVED | — |
| Type 2 Diabetes |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abstention | Behavioral | — | UNRESOLVED |
| Moderate Alcohol Drinking Pattern | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Moderation
- description
- 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.
- interventionNames
- Behavioral: Moderate Alcohol Drinking Pattern
- Behavioral: Abstention
- type
- ACTIVE_COMPARATOR
- label
- Abstention
- description
- Advice on alcohol abstention.
- interventionNames
- Behavioral: Moderate Alcohol Drinking Pattern
- Behavioral: Abstention
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDMartinez-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. PMID 38157987
- BACKGROUNDMartinez-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. PMID 38336153
- BACKGROUNDBarberia-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. PMID 36558468