UNATI
Financiado
A non inferiority randomized trial testing an advice of modeA non inferiority ra...
A non inferiority randomized trial testing an advice of modeA non inferiority randomized trial testing an advice of moderate drinking pattern versus advice on abstention on major disease and mortality
Europeans are the largest alcohol consumers. Policymakers and clinicians are currently perplexed on how to reduce alcohol harms in drinkers, due to contradictory guidelines: abstention is proposed as the healthiest option by many...
Europeans are the largest alcohol consumers. Policymakers and clinicians are currently perplexed on how to reduce alcohol harms in drinkers, due to contradictory guidelines: abstention is proposed as the healthiest option by many health advocates, stating that there is no safe level of alcohol intake; but most nonrandomized studies found lower all-cause mortality and other outcomes in moderate drinkers than in abstainers among subjects >50 years. However, potential biases may compromise these latter studies, particularly when effects are null or moderate. A large pragmatic randomized controlled trial (RCT) of realistic advice aimed to change behavior addressing clinical endpoints is long overdue. It will provide first-level evidence to confront the harms of one of the most widely used substances by humankind. Business issues and conflicts of interests are also at stake.
We propose a 4-year non-inferiority RCT with >10,000 drinkers (men 50-70 years or women 55-70 years consuming >=3 but <40 drinks/wk). To reduce alcohol-associated harms they will be randomized in a 1:1 ratio to 2 advices: 1) abstention; 2) moderation (<=7 drinks/wk (females) and <=14 drinks/wk (males)), and avoidance of binge drinking, with preferential consumption of red wine with meals, and consumption spread out throughout the week. Moderate consumption is hypothesized to be non-inferior. No participant will be invited to increase his/her alcohol intake.
The primary endpoint will be a global index of all-cause mortality, cardiovascular events, cancer, liver disease, depression, dementia, diabetes, tuberculosis or other major infection or injury.
The difficulties for feasibility are significant, but more complex large behavioral trials developed by the principal investigator (PREDIMED and PREDIMED-Plus, two largest nutritional trials conducted in Europe) have attained sufficient compliance in changing not only one aspect of the dietary pattern (alcohol) but many aspects of diet and lifestyle.
ver más
Duración del proyecto: 65 meses
Fecha Inicio: 2023-06-29
Fecha Fin: 2028-11-30
Fecha Fin: 2028-11-30
Línea de financiación: concedida
El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2023-06-29
Línea de financiación objetivo
El proyecto se financió a través de la siguiente ayuda:
ERC-2022-ADG:
ERC ADVANCED GRANTS
Cerrada
hace 2 años
Presupuesto
El presupuesto total del proyecto asciende a
2M€
Líder del proyecto
UNIVERSIDAD DE NAVARRA
No se ha especificado una descripción o un objeto social para esta compañía.
Total investigadores
849
Total investigadores
849