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"We need the maximum scientific evidence about health advice on alcohol consumption and this trial can provide us with it." Miguel Ángel Martínez, Professor of Preventive Medicine at the University of Navarra and researcher at CIBEROBN has just been selected by the European Research Council (ERC) as one of the beneficiaries of its Advanced Grants, one of the most prestigious and best endowed calls for European scientific funding.

The subsidy, of 2.5 million euros, has been awarded to the UNATI project (acronym for University of Navarra Trialists Initiative), whose objective is to provide evidence on alcohol consumption and its effects on health.

"There is no doubt that, in young people, in Spain, alcohol is doing a lot of damage, especially through a consumption of the 'botellón' type," says Martínez. However, he continues, in older people with other consumption patterns, more studies are needed.

"The relevant question arises in older people whether they follow a 'prudent' pattern of drinking. There are currently two divergent positions regarding the health advice that should be given to those over 50 who regularly maintain a moderate alcohol consumption (between 1 and 2 drinks a day). Great experts in public health defend that health education for these people should lead them towards a Mediterranean pattern of alcohol consumption, which minimizes the risks. But other voices, also very authoritative, defend that they should only be recommended total abstinence. The reality is that there is a lack of top-level scientific evidence to opt for one or the other, "says the researcher through the email.

"What is known so far is based only on observational studies that may have biases or on small short-term trials." This new research "will allow an answer based for the first time on a large randomized trial with long-term follow-up," he adds.

Effects of alcohol

The study, which will be carried out over the next five years, will compare in 10,000 volunteers aged between 50 and 70 years the long-term effects of two different types of advice on alcohol consumption: total abstinence versus moderate consumption of alcohol - mainly wine - in the framework of a Mediterranean diet.

"It is a randomized trial of non-inferiority", underlines Martínez- "It is about assessing whether the advice that points towards moderate alcohol consumption following the Mediterranean pattern is comparable (not inferior) to the advice of total abstention", he points out.

The trial, says the researcher, will not only evaluate the effects of following one or the other pattern, but also to what extent both types of advice have been met.

The project plans to invite doctors graduated from the University of Navarra to participate in the project as researchers. "The design of this trial has aroused great interest because, in addition to answering very practical questions, it applies new technologies and thus allows the workload for medical researchers to be minimized and not interfere with the clinical care of their patients," adds the researcher.

"We need the UNATI trial because there are many things we still don't know for sure. What we know about the effects of alcohol suggests that the answer depends fundamentally on three factors: sex, age and pattern of consumption. The balance of what we know is that it is worse in young people, it is worse in women and it is worse if it is concentrated on the weekend, it is consumed outside of meals and strong drinks are preferred ('botellón' pattern)," says Martínez.

It is not the first time that Martínez has received funding for an ERC research project. Previously, the PREDIMED-Plus study, designed to evaluate the effect of a traditional Mediterranean diet with energy restriction, physical activity and behavioral treatment on the prevention of cardiovascular disease. Interim results of the research were published in 2019 and final conclusions are expected in the coming months.

"We hope that thanks to this grant, Spain will once again be a world leader, as it has been with the Mediterranean diet," concludes Martínez. "It will allow for a response based for the first time on a large randomized trial with long-term follow-up."

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