Clinical trial NCT06214416: Pragmatic Clinical Trial of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL
Official title: Pragmatic Clinical Trial to Compare the Short and Medium Term Effects of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Spain
First posted: 2024-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is intended to recruit a total of 100 participants, including two observational cohorts of abstainers and drinkers. The intervention will be carried out in drinkers willing to change their alcohol consumption, divided into 2 groups of 150 participants, the abstention group and the Mediterranean alcohol-drinking pattern group.
Primary purpose: PREVENTION

Brief summary: NAMETI-Alcohol, from the acronym for Navarra Medical Trialist Initiative, is a pilot study in which two patterns of alcohol consumption, abstention and Mediterranean alcohol-drinking pattern, and their effects on health in the short and medium term will be compared.

Detailed description: Background: Alcohol is the most consumed psychoactive substance in Spain. In 2016 it was the seventh leading risk factor for death and disability-adjusted lost years worldwide, and the first one in people between 15 and 49 years old.In the scientific community there is some controversy about what would be the best approach to face this great problem. On the one hand, there is evidence to recommend that there is no safe level of alcohol. However, on the other hand, there are studies that demonstrate the protective role of a moderate alcohol consumption. In this pilot study both options will be compared.

Methods: It is intended to recruit a total of 100 participants, including two observational cohorts of abstainers and drinkers. The intervention will be carried out in drinkers willing to change their alcohol consumption, divided into 2 groups of 50 participants, the abstention group and the Mediterranean alcohol-drinking pattern group. The Mediterranean alcohol-drinking pattern includes 5 aspects: moderate alcohol consumption (maximum of 1 drinks/day for women and 2 drinks/day for men), spread consumption throughout the week, drink with meals and never with an empty stomach, prefer wine and mainly red wine, as well as completely avoid episodes of binge-drinking. The main objective will be to compare the short and medium term effects on health of both patterns.

Eligibility criteria: Inclusion Criteria:

* Consuming more than 3 drinks a week (except for the abstention-control arm)

Exclusion Criteria:

* Sever chronic disease (cancer, cardiovascular disease, chronic hepatitis and mental illness)
* Pregnant women or breastfeeding
* Family or personal history of addiction, alcoholism or alcohol abuse

Primary outcomes:
measure: Glucose (mg/dl)
timeFrame: 1 year
measure: HDL-Cholesterol (mg/dl)
timeFrame: 1year
measure: Total cholesterol (mg/dl)
timeFrame: 1year
measure: Triglycerides (mg/dl)
timeFrame: 1 year
measure: Alanine Aminotransferase (ALT) (IU/L)
timeFrame: 1 year
measure: Aspartate transaminase (AST) (IU/L)
timeFrame: 1 year
measure: Gamma-glutamyltransferase (GGT) (IU/L)
timeFrame: 1 year
measure: c-Reactive Protein (CRP) (mg/L)
timeFrame: 1 year
measure: Blood pressure (mm Hg)
timeFrame: 1 year
Secondary outcomes:
measure: Mental health
timeFrame: 1 year
measure: Weight (kg)
timeFrame: 1 year
measure: Adherence to the intervention
timeFrame: 1 year
measure: Body Mass Index (BMI) (kg/m2)
timeFrame: 1 year
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: University of Navarra
state: Navarra
Study officials:
References: