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

NCT06214416 | Completed DMC

• 1 other identifier: NAMETI_ALCOHOL_10_2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Mental health

  1 year

• Weight (kg)

  1 year

• Adherence to the intervention

  1 year

• Body Mass Index (BMI) (kg/m2)

  1 year

Study Arms (4)

Abstention

ACTIVE COMPARATOR

These participants will be encouraged to totally avoid alcohol consumption.

Behavioral: Abstention

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.

Behavioral: Mediterranean alcohol-drinking pattern

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.

Interventions

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.

Abstention

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.

Mediterranean alcohol-drinking pattern

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Ministry of Health, Spain: collaborator

Study Sites (1)

University of Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: January 19, 2024
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

ES (1)