All Cause MortalityUNATINCT06338215
Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
A study testing Moderate Alcohol Drinking Pattern and Abstention in people with All Cause Mortality and Cardiovascular Diseases, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years). The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- All Cause Mortality, Cardiovascular Diseases, Invasive Cancer
- What is being tested?
- Moderate Alcohol Drinking Pattern and Abstention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2024to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males aged 50-70 years, Women aged 55-75 years
- Drinkers of any alcoholic beverage initially consuming 3 or more but 40 or less drinks/wk
- Projected life expectancy more than 5 years (according to the judgment of their attending physician)
- Willing to receive advice during up to 4 years on how to improve their alcohol intake making it healthier
Who cannot join
- Participants without smartphone or a computer (or tablet) with Internet connection.
- Drinkers of less than 30 g of pure alcohol/wk or more than 400 g of pure alcohol/wk
- Illiteracy, inability/unwillingness to give written consent or communicate with study staff, or inadequate abilities for the use of on-line technologies
- Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia.
- Participants with liver cirrhosis or prior liver cancer.
- Patients with a recent diagnosis of breast cancer (diagnosed in the last 10 years).
- Patients under habitual use of high-dose medications that completely preclude any use of alcohol. Most of these patients will be already excluded by the second or fourth exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Navarra
Pamplona, Navarre, 31008
Estíbaliz Goñi, Nutritionist, 34948425600 ext. 80-6596, egonioch@unav.es
Rafael Perez-Araluce, PharmD, +34948425600 ext. 80-6672, rperez.21@alumni.unav.es
About this study
Official title: A Non-inferiority Randomized Trial Testing an Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years).
The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes.
Read more
Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine.
Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases.
Read the detailed description
Policymakers and clinicians are currently perplexed on how to reduce alcohol harms in drinkers, because of contradictory guidelines: abstention is proposed as the healthiest option by many health advocates, stating that "there is no safe level of alcohol intake"; but most nonrandomized studies found lower all-cause mortality and other beneficial outcomes in moderate drinkers than in abstainers among subjects \>50 years. However, potential biases may compromise these latter studies, particularly when effects are null or moderate. A large pragmatic randomized controlled trial (RCT) of realistic advice aimed to change behaviour addressing clinical endpoints is long overdue. It will provide first-level evidence to confront the harms of one of the most widely used substances by humankind.
The European Research Council has funded, through an Advanced Research Grant (2023-2028) to the University of Navarra (Spain), as Host Institution, a 4-year non-inferiority RCT with more than 10,000 drinkers (men 50-70 years or women 55-75 years consuming 3 or more but 40 or less drinks/wk). The name of the trial is UNATI (University of Navarra Alumni Trialist Initiative).
At least ten thousand drinkers will be randomized in a 1:1 ratio to repeatedly (4 contacts/year) receive during 4 years two different advices:
- abstention;
- moderation (7 or less drinks/wk in women and 14 or less drinks/wk in men), avoidance of binge drinking, with preference for red wine consumed always with meals, and consumption spread out throughout the week, following the traditional Mediterranean Alcohol Drinking Pattern (MADP). Moderate consumption is hypothesized to be non-inferior. No initiation or increment in alcohol intake will be promoted.
The primary endpoint will be a global index of all-cause mortality, cardiovascular events, any invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, injury requiring hospital admission or tuberculosis or other infections requiring hospitalization. As a secondary analysis, the most severe outcomes (mortality, invasive cancer, stroke, myocardial infarction, liver cirrhosis) will be considered independently with sufficient priority over less severe outcomes, using ad hoc methods.
The UNATI trial will provide for the first time an evidence-based answer to a question of the utmost interest in clinical medicine, given the high prevalence of moderate alcohol intake, and the current situation of equipoise with opposing views in the scientific community on the most sensible advice for moderate drinkers. The starting date for the project is December 1, 2023. The randomization of participants will start on June 2024.
- Conditions
- All Cause Mortality, Cardiovascular Diseases, Invasive Cancer, Liver Cirrhosis, Type 2 Diabetes, Depression
- Being tested
- Moderate Alcohol Drinking Pattern, Abstention
- Keywords
- Alcohol, Drinking Pattern, Abstention, Advice, Clinical Trial, Moderation, Mediterranean Alcohol Drinking Pattern
- Medical subject headings
- Cardiovascular Diseases, Liver Cirrhosis, Diabetes Mellitus, Type 2, Depression, Dementia, Wounds and Injuries, Tuberculosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Alcohol Drinking PatternBehavioural
Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months.
Goals of intervention:
- moderate consumption (7 or less drinks/wk for women, 14 or less drinks/wk for men) of red wine (a drink=150 ml).
- always during meals
- spread out throughout the whole week, and
- avoidance of binge-drinking episodes. No participant will be invited to start or increase his/her alcohol intake.
AbstentionBehavioural
Remotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months.
Goals of intervention:
Abstention. Message of 0 alcohol.
| Study group | Role | What they receive |
|---|---|---|
| Moderation | Experimental | Advice about alcohol intake following a Mediterranean Alcohol Drinking Pattern: Moderation (7 or less drinks/wk in women and 14 or less drinks/wk in men), avoidance of binge drinking, consumption of alcohol with meals and preference for red wine. Receives: Behavioral: Moderate Alcohol Drinking Pattern; Behavioral: Abstention |
| Abstention | Active comparator | Advice on alcohol abstention. Receives: Behavioral: Moderate Alcohol Drinking Pattern; Behavioral: Abstention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases
Global index of all-cause mortality, cardiovascular events, any invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, injury requiring hospital admission, tuberculosis or other infections requiring hospitalization evaluated from the information on clinical records.
Measured: From enrollment to the end of the intervention up to 4 years.
Secondary outcomes (1)
Comparison between groups of the incidence of the most severe outcomes
The most severe outcomes (mortality, invasive cancer, stroke, myocardial infarction, liver cirrhosis) will be considered independently with sufficient priority over less sever outcomes, using ad hoc methods, using information on clinical records.
Measured: From enrollment to the end of the intervention up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start15 May 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for All Cause MortalityStudies 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel A Martinez-Gonzalez, MD, MPH, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338215
- Sponsor's protocol ID
- UNATI_2024
- Other IDs
- 101097681
- Acronym
- UNATI
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The generated dataset (completely anonymized) will be made available to every proficient researcher who may present a relevant research proposal to the Steering Committee for further exploitation of the data upon all the usual legal precautions for the protection of individual data will be respected.
Publications
Martinez-Gonzalez MA. Should we remove wine from the Mediterranean diet?: a narrative review. Am J Clin Nutr. 2024 Feb;119(2):262-270. doi: 10.1016/j.ajcnut.2023.12.020. Epub 2023 Dec 28.
PubMed 38157987Martinez-Gonzalez MA, Hernandez Hernandez A. Effect of the Mediterranean diet in cardiovascular prevention. Rev Esp Cardiol (Engl Ed). 2024 Jul;77(7):574-582. doi: 10.1016/j.rec.2024.01.006. Epub 2024 Feb 7. English, Spanish.
PubMed 38336153Barberia-Latasa M, Bes-Rastrollo M, Perez-Araluce R, Martinez-Gonzalez MA, Gea A. Mediterranean Alcohol-Drinking Patterns and All-Cause Mortality in Women More Than 55 Years Old and Men More Than 50 Years Old in the "Seguimiento Universidad de Navarra" (SUN) Cohort. Nutrients. 2022 Dec 14;14(24):5310. doi: 10.3390/nu14245310.
PubMed 36558468
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-inferiority Randomized Trial Testing an Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
- ClinicalTrials.gov ID
- NCT06338215
- Acronym / sponsor ID
- UNATI / UNATI_2024
- Conditions
- All Cause Mortality, Cardiovascular Diseases, Invasive Cancer, Liver Cirrhosis, Type 2 Diabetes, Depression
- Keywords
- Alcohol, Drinking Pattern, Abstention, Advice, Clinical Trial, Moderation, Mediterranean Alcohol Drinking Pattern
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 29 Mar 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.
The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years).
The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes.
Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine.
Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases.
Detailed description
Policymakers and clinicians are currently perplexed on how to reduce alcohol harms in drinkers, because of contradictory guidelines: abstention is proposed as the healthiest option by many health advocates, stating that "there is no safe level of alcohol intake"; but most nonrandomized studies found lower all-cause mortality and other beneficial outcomes in moderate drinkers than in abstainers among subjects \>50 years. However, potential biases may compromise these latter studies, particularly when effects are null or moderate. A large pragmatic randomized controlled trial (RCT) of realistic advice aimed to change behaviour addressing clinical endpoints is long overdue. It will provide first-level evidence to confront the harms of one of the most widely used substances by humankind.
The European Research Council has funded, through an Advanced Research Grant (2023-2028) to the University of Navarra (Spain), as Host Institution, a 4-year non-inferiority RCT with more than 10,000 drinkers (men 50-70 years or women 55-75 years consuming 3 or more but 40 or less drinks/wk). The name of the trial is UNATI (University of Navarra Alumni Trialist Initiative).
At least ten thousand drinkers will be randomized in a 1:1 ratio to repeatedly (4 contacts/year) receive during 4 years two different advices:
- abstention;
- moderation (7 or less drinks/wk in women and 14 or less drinks/wk in men), avoidance of binge drinking, with preference for red wine consumed always with meals, and consumption spread out throughout the week, following the traditional Mediterranean Alcohol Drinking Pattern (MADP). Moderate consumption is hypothesized to be non-inferior. No initiation or increment in alcohol intake will be promoted.
The primary endpoint will be a global index of all-cause mortality, cardiovascular events, any invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, injury requiring hospital admission or tuberculosis or other infections requiring hospitalization. As a secondary analysis, the most severe outcomes (mortality, invasive cancer, stroke, myocardial infarction, liver cirrhosis) will be considered independently with sufficient priority over less severe outcomes, using ad hoc methods.
The UNATI trial will provide for the first time an evidence-based answer to a question of the utmost interest in clinical medicine, given the high prevalence of moderate alcohol intake, and the current situation of equipoise with opposing views in the scientific community on the most sensible advice for moderate drinkers. The starting date for the project is December 1, 2023. The randomization of participants will start on June 2024.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderation | Experimental | Behavioral: Moderate Alcohol Drinking Pattern, Behavioral: AbstentionAdvice about alcohol intake following a Mediterranean Alcohol Drinking Pattern: Moderation (7 or less drinks/wk in women and 14 or less drinks/wk in men), avoidance of binge drinking, consumption of alcohol with meals and preference for red wine. |
| Abstention | Active comparator | Behavioral: Moderate Alcohol Drinking Pattern, Behavioral: AbstentionAdvice on alcohol abstention. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males aged 50-70 years, Women aged 55-75 years
- Drinkers of any alcoholic beverage initially consuming 3 or more but 40 or less drinks/wk
- Projected life expectancy more than 5 years (according to the judgment of their attending physician)
- Willing to receive advice during up to 4 years on how to improve their alcohol intake making it healthier
Key exclusion criteria (7 listed)
- Participants without smartphone or a computer (or tablet) with Internet connection.
- Drinkers of less than 30 g of pure alcohol/wk or more than 400 g of pure alcohol/wk
- Illiteracy, inability/unwillingness to give written consent or communicate with study staff, or inadequate abilities for the use of on-line technologies
- Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia.
- Participants with liver cirrhosis or prior liver cancer.
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 |
|---|---|---|
| Moderate Alcohol Drinking PatternRemotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months. Goals of intervention: 1. moderate consumption (7 or less drinks/wk for women, 14 or less drinks/wk for men) of red wine (a drink=150 ml). 2. always during meals 3. spread out throughout the whole week, and 4. avoidance of binge-drinking episodes. No participant will be invited to start or increase his/her alcohol intake. | Behavioural | Abstention, Moderation |
| AbstentionRemotely Intensive intervention by specialized coaches (psychologists, dietitians, and other health professionals) to promote a behavior change on alcohol consumption. Repeated quarterly small group sessions and periodical personal interviews and educational videos, during up to 4 years with 1 contact every 3 months. Goals of intervention: Abstention. Message of 0 alcohol. | Behavioural | Abstention, Moderation |
Primary outcome
Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases
Time frame: From enrollment to the end of the intervention up to 4 years.
Global index of all-cause mortality, cardiovascular events, any invasive cancer, liver cirrhosis, type 2 diabetes, depression, dementia, injury requiring hospital admission, tuberculosis or other infections requiring hospitalization evaluated from the information on clinical records.
1 secondary outcome
Comparison between groups of the incidence of the most severe outcomes
Time frame: From enrollment to the end of the intervention up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 38157987Martinez-Gonzalez MA. Should we remove wine from the Mediterranean diet?: a narrative review. Am J Clin Nutr. 2024 Feb;119(2):262-270. doi: 10.1016/j.ajcnut.2023.12.020. Epub 2023 Dec 28.
- Background: PubMed 38336153Martinez-Gonzalez MA, Hernandez Hernandez A. Effect of the Mediterranean diet in cardiovascular prevention. Rev Esp Cardiol (Engl Ed). 2024 Jul;77(7):574-582. doi: 10.1016/j.rec.2024.01.006. Epub 2024 Feb 7. English, Spanish.
- Background: PubMed 36558468Barberia-Latasa M, Bes-Rastrollo M, Perez-Araluce R, Martinez-Gonzalez MA, Gea A. Mediterranean Alcohol-Drinking Patterns and All-Cause Mortality in Women More Than 55 Years Old and Men More Than 50 Years Old in the "Seguimiento Universidad de Navarra" (SUN) Cohort. Nutrients. 2022 Dec 14;14(24):5310. doi: 10.3390/nu14245310.
- Individual participant dataSharing planned: Yes. The generated dataset (completely anonymized) will be made available to every proficient researcher who may present a relevant research proposal to the Steering Committee for further exploitation of the data upon all the usual legal precautions for the protection of individual data will be respected.
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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.
Miguel A Martinez-Gonzalez, MD, MPH, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Alcohol Drinking Pattern and Abstention in people with All Cause Mortality and Cardiovascular Diseases, 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel A Martinez-Gonzalez, MD, MPH, PhD (+34948425600 ext. 806463, mamartinez@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases (time frame: From enrollment to the end of the intervention up to 4 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338215, which also lists 3 linked publications.
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 12 Dec 2024.