Alcohol Drinking
Conditions
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.
Interventions
BEHAVIORALAbstention
All the intervention will be carried out online once a month for a year, focusing on nutritional, behavioral and scientific evidence aspects, that promote abstention.
BEHAVIORALMediterranean alcohol-drinking pattern
All the intervention will be carried out online once a month for a year, focusing on nutritional, behavioral and scientific evidence aspects, that promote the Mediterranean alcohol-drinking pattern.
Sponsors
Ministry of Health, Spain
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure (mm Hg) | 1 year | Changes differences in systolic and diastolic blood pressure |
| Alanine Aminotransferase (ALT) (IU/L) | 1 year | Changes differences in ALT |
| Aspartate transaminase (AST) (IU/L) | 1 year | Changes differences in AST |
| Gamma-glutamyltransferase (GGT) (IU/L) | 1 year | Changes differences in GGT |
| c-Reactive Protein (CRP) (mg/L) | 1 year | Changes differences in CRP |
| Glucose (mg/dl) | 1 year | Changes differences in glucose levels |
| HDL-Cholesterol (mg/dl) | 1year | Changes differences in HDL-Cholesterol levels |
| Total cholesterol (mg/dl) | 1year | Changes differences in total cholesterol levels |
| Triglycerides (mg/dl) | 1 year | Changes differences in triglycerides |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight (kg) | 1 year | Changes in weight (kg) |
| Adherence to the intervention | 1 year | Levels of resveratrol in urine and hydroxytyrosol in plasma and urine |
| Body Mass Index (BMI) (kg/m2) | 1 year | Changes in BMI, assessed through weight(kg) and height (m) (BMI=Weight/(Height)\^2 |
| Mental health | 1 year | Through Beck's questionnaire, Lobo's mini-cognitive exam (Mini-Mental State examination) and clock drawing test |
Countries
Spain
Outcome results
None listed