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| Name | Class |
|---|---|
| Ministry of Health, Spain | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abstention | Active Comparator | These participants will be encouraged to totally avoid alcohol consumption. |
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| Mediterranean alcohol-drinking pattern | Active Comparator | These participants will be encouraged to change their pattern of consumption to a more Mediterranean way, which includes 5 aspects: moderate alcohol consumption (maximum of 2 drinks/day for women and 4 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. |
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| Control of abstainers | No Intervention | This group will include all participants who consume less than 3 alcohol drinks a week at the time of recruitment. | |
| Control of drinkers | No Intervention | This group will include all participants who don't want to change their alcohol-drinking pattern. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abstention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose (mg/dl) | Changes differences in glucose levels | 1 year |
| HDL-Cholesterol (mg/dl) | Changes differences in HDL-Cholesterol levels | 1year |
| Total cholesterol (mg/dl) | Changes differences in total cholesterol levels | 1year |
| Triglycerides (mg/dl) | Changes differences in triglycerides | 1 year |
| Alanine Aminotransferase (ALT) (IU/L) | Changes differences in ALT | 1 year |
| Aspartate transaminase (AST) (IU/L) | Changes differences in AST | 1 year |
| Gamma-glutamyltransferase (GGT) (IU/L) | Changes differences in GGT | 1 year |
| c-Reactive Protein (CRP) (mg/L) | Changes differences in CRP | 1 year |
| Blood pressure (mm Hg) | Changes differences in systolic and diastolic blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Mental health | Through Beck's questionnaire, Lobo's mini-cognitive exam (Mini-Mental State examination) and clock drawing test | 1 year |
| Weight (kg) | Changes in weight (kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Navarra | Pamplona | Navarre | 31008 | Spain |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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.
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| Mediterranean alcohol-drinking pattern | Behavioral | 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. |
|
| 1 year |
| 1 year |
| Adherence to the intervention | Levels of resveratrol in urine and hydroxytyrosol in plasma and urine | 1 year |
| Body Mass Index (BMI) (kg/m2) | Changes in BMI, assessed through weight(kg) and height (m) (BMI=Weight/(Height)^2 | 1 year |