Pragmatic Clinical Trial of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL (NAMETI_ALCOHOL)

Pragmatic Clinical Trial to Compare the Short and Medium Term Effects of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: Abstention; Behavioral: Mediterranean alcohol-drinking pattern

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • University of Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Abstention; These participants will be encouraged to totally avoid alcohol consumption.	Behavioral: Abstention; 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.
Active Comparator: Mediterranean alcohol-drinking pattern; 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.	Behavioral: Mediterranean 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.
No Intervention: Control of abstainers; This group will include all participants who consume less than 3 alcohol drinks a week at the time of recruitment.
No Intervention: Control of drinkers; This group will include all participants who don't want to change their alcohol-drinking pattern.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	1 year

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: Ministry of Health, Spain

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: NAMETI_ALCOHOL_10_2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No