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

Alcohol Drinking Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06214416
• Other study ID #: NAMETI_ALCOHOL_10_2020
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	University of Navarra	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose (mg/dl)	Changes differences in glucose levels	1 year
Primary	HDL-Cholesterol (mg/dl)	Changes differences in HDL-Cholesterol levels	1year
Primary	Total cholesterol (mg/dl)	Changes differences in total cholesterol levels	1year
Primary	Triglycerides (mg/dl)	Changes differences in triglycerides	1 year
Primary	Alanine Aminotransferase (ALT) (IU/L)	Changes differences in ALT	1 year
Primary	Aspartate transaminase (AST) (IU/L)	Changes differences in AST	1 year
Primary	Gamma-glutamyltransferase (GGT) (IU/L)	Changes differences in GGT	1 year
Primary	c-Reactive Protein (CRP) (mg/L)	Changes differences in CRP	1 year
Primary	Blood pressure (mm Hg)	Changes differences in systolic and diastolic blood pressure	1 year
Secondary	Mental health	Through Beck's questionnaire, Lobo's mini-cognitive exam (Mini-Mental State examination) and clock drawing test	1 year
Secondary	Weight (kg)	Changes in weight (kg)	1 year
Secondary	Adherence to the intervention	Levels of resveratrol in urine and hydroxytyrosol in plasma and urine	1 year
Secondary	Body Mass Index (BMI) (kg/m2)	Changes in BMI, assessed through weight(kg) and height (m) (BMI=Weight/(Height)^2	1 year