Alcohol DrinkingNAMETI_ALCOHOLNCT06214416
Pragmatic Clinical Trial of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL
A study testing Abstention and Mediterranean alcohol-drinking pattern in people with Alcohol Drinking, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Abstention and Mediterranean alcohol-drinking pattern
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consuming more than 3 drinks a week (except for the abstention-control arm)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Drinking
- Being tested
- Abstention, Mediterranean alcohol-drinking pattern
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbstentionBehavioural
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 patternBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Abstention | Active comparator | These participants will be encouraged to totally avoid alcohol consumption. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose (mg/dl)
Changes differences in glucose levels
Measured: 1 year
HDL-Cholesterol (mg/dl)
Changes differences in HDL-Cholesterol levels
Measured: 1year
Total cholesterol (mg/dl)
Changes differences in total cholesterol levels
Measured: 1year
Triglycerides (mg/dl)
Changes differences in triglycerides
Measured: 1 year
Alanine Aminotransferase (ALT) (IU/L)
Changes differences in ALT
Measured: 1 year
Aspartate transaminase (AST) (IU/L)
Changes differences in AST
Measured: 1 year
Gamma-glutamyltransferase (GGT) (IU/L)
Changes differences in GGT
Measured: 1 year
c-Reactive Protein (CRP) (mg/L)
Changes differences in CRP
Measured: 1 year
Blood pressure (mm Hg)
Changes differences in systolic and diastolic blood pressure
Measured: 1 year
Secondary outcomes (4)
Mental health
Through Beck's questionnaire, Lobo's mini-cognitive exam (Mini-Mental State examination) and clock drawing test
Measured: 1 year
Weight (kg)
Changes in weight (kg)
Measured: 1 year
Adherence to the intervention
Levels of resveratrol in urine and hydroxytyrosol in plasma and urine
Measured: 1 year
Body Mass Index (BMI) (kg/m2)
Changes in BMI, assessed through weight(kg) and height (m) (BMI=Weight/(Height)^2
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Nov 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Spain
- Responsible party
- Principal investigator, Maira Bes Rastrollo, Clinica Universidad de Navarra, Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214416
- Sponsor's protocol ID
- NAMETI_ALCOHOL_10_2020
- Acronym
- NAMETI_ALCOHOL
- Status last verified
- Jan 2024
- First submitted
- 25 May 2022
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Clinical Trial to Compare the Short and Medium Term Effects of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL
- ClinicalTrials.gov ID
- NCT06214416
- Acronym / sponsor ID
- NAMETI_ALCOHOL / NAMETI_ALCOHOL_10_2020
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Ministry of Health, Spain
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Abstention | Active comparator | Behavioral: AbstentionThese participants will be encouraged to totally avoid alcohol consumption. |
| Mediterranean alcohol-drinking pattern | Active comparator | Behavioral: Mediterranean alcohol-drinking patternThese 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consuming more than 3 drinks a week (except for the abstention-control arm)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbstentionAll the intervention will be carried out online once a month for a year, focusing on nutritional, behavioral and scientific evidence aspects, that promote abstention. | Behavioural | Abstention |
| Mediterranean alcohol-drinking patternAll 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. | Behavioural | Mediterranean alcohol-drinking pattern |
Primary outcome
Glucose (mg/dl)
Time frame: 1 year
Changes differences in glucose levels
HDL-Cholesterol (mg/dl)
Time frame: 1year
Changes differences in HDL-Cholesterol levels
Total cholesterol (mg/dl)
Time frame: 1year
Changes differences in total cholesterol levels
Triglycerides (mg/dl)
Time frame: 1 year
Changes differences in triglycerides
Alanine Aminotransferase (ALT) (IU/L)
Time frame: 1 year
Changes differences in ALT
Aspartate transaminase (AST) (IU/L)
Time frame: 1 year
Changes differences in AST
Gamma-glutamyltransferase (GGT) (IU/L)
Time frame: 1 year
Changes differences in GGT
c-Reactive Protein (CRP) (mg/L)
Time frame: 1 year
Changes differences in CRP
Blood pressure (mm Hg)
Time frame: 1 year
Changes differences in systolic and diastolic blood pressure
4 secondary outcomes
Mental health
Time frame: 1 year
Weight (kg)
Time frame: 1 year
Adherence to the intervention
Time frame: 1 year
Body Mass Index (BMI) (kg/m2)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
Related trials for Alcohol Drinking
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abstention and Mediterranean alcohol-drinking pattern in people with Alcohol Drinking, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose (mg/dl) (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.