Quality of LifeWISENCT05261620
Wine Implementation for Surgical Recovery Enhancement
A study testing red wine in people with Quality of Life, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a monocenter, prospective randomized clinical trial. The study aims to investigate whether moderate consumption of red wine (1 unit at lunch and 1 unit at dinner) for 30 days after surgery could improve the quality of life (QoL) and health perception status of the patient, without increasing the morbidity and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- red wine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteItaly
- Study dates
- 12 Dec 2022to 12 Jun 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years-old or older
- Candidate to surgery
- Willing to follow the protocol
- Signed informed consent
Who cannot join
- Severe Chronic Kidney Disease (eGFR<30)
- Severe liver disease (Child-Pugh B or C)
- Severe heart failure (NYHA Classes III-IV)
- body mass index lower than 18 or higher than 30 kg/m2
- Pregnant woman
- Teetotal subjects
Show all 11Show fewer
- History of alcohol abuse evaluated through AUDIT questionnaire and qualitative interview by a psychologist
- Higher than moderate alcohol intake consumers (more than 25 g of alcohol per day for women and 40 g of alcohol per day for men)
- Type I diabetes
- Severe respiratory diseases like chronic obstructive pulmonary disease (GOLD classes III-IV)
- Neurological diseases such as Alzheimer's, Parkinson's, fibromyalgia or multiple sclerosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: W.I.S.E.-Wine Implementation for Surgical Recovery Enhancement
This is a monocenter, prospective randomized clinical trial. The study aims to investigate whether moderate consumption of red wine (1 unit at lunch and 1 unit at dinner) for 30 days after surgery could improve the quality of life (QoL) and health perception status of the patient, without increasing the morbidity and the toxicity related to the surgery.
Read the detailed description
Participants are randomized to receive either the standard of care (SoC - no alcohol assumption) (Control Arm) or the standard of care plus wine-controlled intake (Experimental Arm). All participants are candidates for surgery and habitual consumers of alcohol-containing beverages (7-21 alcohol-containing beverages per week) with a body mass index between 18 and 30 kg/m2.
Control Arm subjects adhere to diet free of any alcohol-containing beverages, as normally recommended by surgeons in their clinical practice.
Subjects assigned to the Experimental Arm adhere to usual diet, but were instructed to "Western prudent" dietary principles of the Lyon Diet Heart study, which is the reference in terms of cardiovascular protection, to avoid supplementation of multivitamin, minerals or probiotics, to not drink more than 2 cups of coffee, black or green tea per day and to supervise the intake of food rich in phenolic compounds through providing a list of suggested foods. Subjects will be randomly assigned to consume exclusively during meals one glass (around 150 ml at lunch and 150 ml at dinner) of red wine containing ethanol (˜13% EtOH v/v) with a high content of phenolic compounds (800 mg of Gallic acid equivalent) both for woman and men. Total polyphenolic contents and antioxidant activity (Folin-Ciocalteu method with calibration curve in gallic acid), antioxidant/radical scavenger capacity [DPPH (2,2-diphenyl-1-picrylhydrazyl) test] and phenolic profiles [HPLC (High Performance Liquid Chromatography)/DAD (diode-array detector) /ESI-MS (Electrospray Ionisation Mass Spectrometry) analysis] will be performed for wine selection for the clinical trial. The wine administered for the study purposes will be chosen from a series of wines that will be proposed by the sponsor of the study. The wine with the best polyphenolic and antioxidant properties will be chosen to be administered to the enrolled patients.
For both randomized groups, SoC plus W.I.S.E and SoC only, in order to assess participant's alcohol consumption, a trained psychologist will administer the AUDIT questionnaire specific for alcoholic drinks and a qualitative interview to patients. Frequency of intake is scheduled and each participant will be allowed to drink up to a single unit of wine at lunch and a single unit of red wine at dinner per day from the first post-operative day, during all the hospital stay, and for the next 30 days
- Conditions
- Quality of Life
- Being tested
- red wine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red wineDietary supplement
Subjects in the intervention arm (SoC+WISE) will be assigned to consume exclusively during meals one glass (around 150 ml at lunch and 150 ml at dinner) of red wine containing ethanol (˜13% EtOH v/v) with a high content of phenolic compounds (800 mg of Gallic acid equivalent) both for woman and men. Total polyphenolic contents and antioxidant activity (Folin-Ciocalteu method with calibration curve in gallic acid), antioxidant/radical scavenger capacity [DPPH (2,2-diphenyl-1-picrylhydrazyl) test] and phenolic profiles [HPLC (High Performance Liquid Chromatography)/DAD (diode-array detector) /ESI-MS (Electrospray Ionisation Mass Spectrometry) analysis] will be performed for wine selection for the clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| SoC + WISE | Experimental | Candidates for surgery and habitual consumers of alcohol-containing beverages (7-21 alcohol-containing beverages per week) with a body mass index between 18 and 30 kg/m2. Subjects assigned to the Experimental Arm will be assigned to consume exclusively during meals one glass (around 150 ml at lunch and 150 ml at dinner) of red wine containing ethanol (˜13% EtOH v/v) with a high content of phenolic compounds (800 mg of Gallic acid equivalent). Receives: Dietary Supplement: red wine |
| SoC | No intervention | Control Arm subjects adhere to diet free of any alcohol-containing beverages, as normally recommended by surgeons in their clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants consuming red wine after surgery showing improved health perception status assessed with the Mental Health Index (MHI) of the Short Form-36 Health Survey questionnaire
Health perception status measured using the Mental Health Index (MHI) of the Short Form-36 Health Survey
Measured: 30 days
Secondary outcomes (4)
Number of Participants consuming red wine With post-operative complications assessed with Clavien-Dindo classification
Rate of post-operative complications according to Clavien-Dindo classification
Measured: 30 days
Number of Participants consuming red wine experiencing hospital readmissions after surgery
Rate of hospital readmissions from surgery
Measured: 30 days
Number of male Participants consuming red wine with change in sexual perceptions after surgery using IIEF questionnaire
To evaluate changes in sexual perceptions after surgery using IIEF questionnaire
Measured: 30 days
Number of Participants consuming red wine with a change in blood oxidative stress markers assessed using ORAC (Oxygen Radical Absorbance Capacity) tests
Oxidative stress will be assessed using ORAC (Oxygen Radical Absorbance Capacity) tests.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start12 Dec 2022
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umberto Capitanio, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261620
- Sponsor's protocol ID
- WISE trial
- Acronym
- WISE
- Status last verified
- Jun 2025
- First submitted
- 16 Sep 2021
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim SJ, Kim DJ. Alcoholism and diabetes mellitus. Diabetes Metab J. 2012 Apr;36(2):108-15. doi: 10.4093/dmj.2012.36.2.108. Epub 2012 Apr 17.
PubMed 22540046Chiva-Blanch G, Arranz S, Lamuela-Raventos RM, Estruch R. Effects of wine, alcohol and polyphenols on cardiovascular disease risk factors: evidences from human studies. Alcohol Alcohol. 2013 May-Jun;48(3):270-7. doi: 10.1093/alcalc/agt007. Epub 2013 Feb 13.
PubMed 23408240Roerecke M, Rehm J. Alcohol consumption, drinking patterns, and ischemic heart disease: a narrative review of meta-analyses and a systematic review and meta-analysis of the impact of heavy drinking occasions on risk for moderate drinkers. BMC Med. 2014 Oct 21;12:182. doi: 10.1186/s12916-014-0182-6.
PubMed 25567363Schrieks IC, Heil AL, Hendriks HF, Mukamal KJ, Beulens JW. The effect of alcohol consumption on insulin sensitivity and glycemic status: a systematic review and meta-analysis of intervention studies. Diabetes Care. 2015 Apr;38(4):723-32. doi: 10.2337/dc14-1556.
PubMed 25805864Gea A, Beunza JJ, Estruch R, Sanchez-Villegas A, Salas-Salvado J, Buil-Cosiales P, Gomez-Gracia E, Covas MI, Corella D, Fiol M, Aros F, Lapetra J, Lamuela-Raventos RM, Warnberg J, Pinto X, Serra-Majem L, Martinez-Gonzalez MA; PREDIMED GROUP. Alcohol intake, wine consumption and the development of depression: the PREDIMED study. BMC Med. 2013 Aug 30;11:192. doi: 10.1186/1741-7015-11-192.
PubMed 23988010Gea A, Martinez-Gonzalez MA, Toledo E, Sanchez-Villegas A, Bes-Rastrollo M, Nunez-Cordoba JM, Sayon-Orea C, Beunza JJ. A longitudinal assessment of alcohol intake and incident depression: the SUN project. BMC Public Health. 2012 Nov 7;12:954. doi: 10.1186/1471-2458-12-954.
PubMed 23134690Rosell M, De Faire U, Hellenius ML. Low prevalence of the metabolic syndrome in wine drinkers--is it the alcohol beverage or the lifestyle? Eur J Clin Nutr. 2003 Feb;57(2):227-34. doi: 10.1038/sj.ejcn.1601548.
PubMed 12571653Scrimgeour LA, Potz BA, Elmadhun NY, Chu LM, Sellke FW. Alcohol attenuates myocardial ischemic injury. Surgery. 2017 Sep;162(3):680-687. doi: 10.1016/j.surg.2017.04.014. Epub 2017 Jun 9.
PubMed 28602493Roerecke M, Rehm J. The cardioprotective association of average alcohol consumption and ischaemic heart disease: a systematic review and meta-analysis. Addiction. 2012 Jul;107(7):1246-60. doi: 10.1111/j.1360-0443.2012.03780.x. Epub 2012 Mar 21.
PubMed 22229788Cosmi F, Di Giulio P, Masson S, Finzi A, Marfisi RM, Cosmi D, Scarano M, Tognoni G, Maggioni AP, Porcu M, Boni S, Cutrupi G, Tavazzi L, Latini R; GISSI-HF Investigators. Regular wine consumption in chronic heart failure: impact on outcomes, quality of life, and circulating biomarkers. Circ Heart Fail. 2015 May;8(3):428-37. doi: 10.1161/CIRCHEARTFAILURE.114.002091. Epub 2015 Apr 29.
PubMed 25925415Gonzalez-Rubio E, San Mauro I, Lopez-Ruiz C, Diaz-Prieto LE, Marcos A, Nova E. Relationship of moderate alcohol intake and type of beverage with health behaviors and quality of life in elderly subjects. Qual Life Res. 2016 Aug;25(8):1931-42. doi: 10.1007/s11136-016-1229-2. Epub 2016 Jan 21.
PubMed 26797806Mortensen EL, Jensen HH, Sanders SA, Reinisch JM. Better psychological functioning and higher social status may largely explain the apparent health benefits of wine: a study of wine and beer drinking in young Danish adults. Arch Intern Med. 2001 Aug 13-27;161(15):1844-8. doi: 10.1001/archinte.161.15.1844.
PubMed 11493125Hansel B, Thomas F, Pannier B, Bean K, Kontush A, Chapman MJ, Guize L, Bruckert E. Relationship between alcohol intake, health and social status and cardiovascular risk factors in the Urban Paris-Ile-de-France Cohort: is the cardioprotective action of alcohol a myth? Eur J Clin Nutr. 2010 Jun;64(6):561-8. doi: 10.1038/ejcn.2010.61. Epub 2010 May 19.
PubMed 20485310Ruidavets JB, Bataille V, Dallongeville J, Simon C, Bingham A, Amouyel P, Arveiler D, Ducimetiere P, Ferrieres J. Alcohol intake and diet in France, the prominent role of lifestyle. Eur Heart J. 2004 Jul;25(13):1153-62. doi: 10.1016/j.ehj.2003.12.022.
PubMed 15231374Mizumoto A, Ohashi S, Hirohashi K, Amanuma Y, Matsuda T, Muto M. Molecular Mechanisms of Acetaldehyde-Mediated Carcinogenesis in Squamous Epithelium. Int J Mol Sci. 2017 Sep 10;18(9):1943. doi: 10.3390/ijms18091943.
PubMed 28891965
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- W.I.S.E.-Wine Implementation for Surgical Recovery Enhancement
- ClinicalTrials.gov ID
- NCT05261620
- Acronym / sponsor ID
- WISE / WISE trial
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 2 Mar 2022 (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.
This is a monocenter, prospective randomized clinical trial. The study aims to investigate whether moderate consumption of red wine (1 unit at lunch and 1 unit at dinner) for 30 days after surgery could improve the quality of life (QoL) and health perception status of the patient, without increasing the morbidity and the toxicity related to the surgery.
Detailed description
Participants are randomized to receive either the standard of care (SoC - no alcohol assumption) (Control Arm) or the standard of care plus wine-controlled intake (Experimental Arm). All participants are candidates for surgery and habitual consumers of alcohol-containing beverages (7-21 alcohol-containing beverages per week) with a body mass index between 18 and 30 kg/m2.
Control Arm subjects adhere to diet free of any alcohol-containing beverages, as normally recommended by surgeons in their clinical practice.
Subjects assigned to the Experimental Arm adhere to usual diet, but were instructed to "Western prudent" dietary principles of the Lyon Diet Heart study, which is the reference in terms of cardiovascular protection, to avoid supplementation of multivitamin, minerals or probiotics, to not drink more than 2 cups of coffee, black or green tea per day and to supervise the intake of food rich in phenolic compounds through providing a list of suggested foods. Subjects will be randomly assigned to consume exclusively during meals one glass (around 150 ml at lunch and 150 ml at dinner) of red wine containing ethanol (˜13% EtOH v/v) with a high content of phenolic compounds (800 mg of Gallic acid equivalent) both for woman and men. Total polyphenolic contents and antioxidant activity (Folin-Ciocalteu method with calibration curve in gallic acid), antioxidant/radical scavenger capacity [DPPH (2,2-diphenyl-1-picrylhydrazyl) test] and phenolic profiles [HPLC (High Performance Liquid Chromatography)/DAD (diode-array detector) /ESI-MS (Electrospray Ionisation Mass Spectrometry) analysis] will be performed for wine selection for the clinical trial. The wine administered for the study purposes will be chosen from a series of wines that will be proposed by the sponsor of the study. The wine with the best polyphenolic and antioxidant properties will be chosen to be administered to the enrolled patients.
For both randomized groups, SoC plus W.I.S.E and SoC only, in order to assess participant's alcohol consumption, a trained psychologist will administer the AUDIT questionnaire specific for alcoholic drinks and a qualitative interview to patients. Frequency of intake is scheduled and each participant will be allowed to drink up to a single unit of wine at lunch and a single unit of red wine at dinner per day from the first post-operative day, during all the hospital stay, and for the next 30 days
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SoC + WISE | Experimental | Dietary Supplement: red wineCandidates for surgery and habitual consumers of alcohol-containing beverages (7-21 alcohol-containing beverages per week) with a body mass index between 18 and 30 kg/m2. Subjects assigned to the Experimental Arm will be assigned to consume exclusively during meals one glass (around 150 ml at lunch and 150 ml at dinner) of red wine containing ethanol (˜13% EtOH v/v) with a high content of phenolic compounds (800 mg of Gallic acid equivalent). |
| SoC | No intervention | –Control Arm subjects adhere to diet free of any alcohol-containing beverages, as normally recommended by surgeons in their clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years-old or older
- Candidate to surgery
- Willing to follow the protocol
- Signed informed consent
Key exclusion criteria (11 listed)
- Severe Chronic Kidney Disease (eGFR<30)
- Severe liver disease (Child-Pugh B or C)
- Severe heart failure (NYHA Classes III-IV)
- body mass index lower than 18 or higher than 30 kg/m2
- Pregnant woman
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 |
|---|---|---|
| red wineSubjects in the intervention arm (SoC+WISE) will be assigned to consume exclusively during meals one glass (around 150 ml at lunch and 150 ml at dinner) of red wine containing ethanol (˜13% EtOH v/v) with a high content of phenolic compounds (800 mg of Gallic acid equivalent) both for woman and men. Total polyphenolic contents and antioxidant activity (Folin-Ciocalteu method with calibration curve in gallic acid), antioxidant/radical scavenger capacity [DPPH (2,2-diphenyl-1-picrylhydrazyl) test] and phenolic profiles [HPLC (High Performance Liquid Chromatography)/DAD (diode-array detector) /ESI-MS (Electrospray Ionisation Mass Spectrometry) analysis] will be performed for wine selection for the clinical trial. | Dietary supplement | SoC + WISE |
Primary outcome
Number of participants consuming red wine after surgery showing improved health perception status assessed with the Mental Health Index (MHI) of the Short Form-36 Health Survey questionnaire
Time frame: 30 days
Health perception status measured using the Mental Health Index (MHI) of the Short Form-36 Health Survey
4 secondary outcomes
Number of Participants consuming red wine With post-operative complications assessed with Clavien-Dindo classification
Time frame: 30 days
Number of Participants consuming red wine experiencing hospital readmissions after surgery
Time frame: 30 days
Number of male Participants consuming red wine with change in sexual perceptions after surgery using IIEF questionnaire
Time frame: 30 days
Number of Participants consuming red wine with a change in blood oxidative stress markers assessed using ORAC (Oxygen Radical Absorbance Capacity) tests
Time frame: 30 days
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 22 Jul 2025.
- Results publication: PubMed 22540046Kim SJ, Kim DJ. Alcoholism and diabetes mellitus. Diabetes Metab J. 2012 Apr;36(2):108-15. doi: 10.4093/dmj.2012.36.2.108. Epub 2012 Apr 17.
- Results publication: PubMed 23408240Chiva-Blanch G, Arranz S, Lamuela-Raventos RM, Estruch R. Effects of wine, alcohol and polyphenols on cardiovascular disease risk factors: evidences from human studies. Alcohol Alcohol. 2013 May-Jun;48(3):270-7. doi: 10.1093/alcalc/agt007. Epub 2013 Feb 13.
- Results publication: PubMed 25567363Roerecke M, Rehm J. Alcohol consumption, drinking patterns, and ischemic heart disease: a narrative review of meta-analyses and a systematic review and meta-analysis of the impact of heavy drinking occasions on risk for moderate drinkers. BMC Med. 2014 Oct 21;12:182. doi: 10.1186/s12916-014-0182-6.
- Results publication: PubMed 25805864Schrieks IC, Heil AL, Hendriks HF, Mukamal KJ, Beulens JW. The effect of alcohol consumption on insulin sensitivity and glycemic status: a systematic review and meta-analysis of intervention studies. Diabetes Care. 2015 Apr;38(4):723-32. doi: 10.2337/dc14-1556.
- Results publication: PubMed 23988010Gea A, Beunza JJ, Estruch R, Sanchez-Villegas A, Salas-Salvado J, Buil-Cosiales P, Gomez-Gracia E, Covas MI, Corella D, Fiol M, Aros F, Lapetra J, Lamuela-Raventos RM, Warnberg J, Pinto X, Serra-Majem L, Martinez-Gonzalez MA; PREDIMED GROUP. Alcohol intake, wine consumption and the development of depression: the PREDIMED study. BMC Med. 2013 Aug 30;11:192. doi: 10.1186/1741-7015-11-192.
- Results publication: PubMed 23134690Gea A, Martinez-Gonzalez MA, Toledo E, Sanchez-Villegas A, Bes-Rastrollo M, Nunez-Cordoba JM, Sayon-Orea C, Beunza JJ. A longitudinal assessment of alcohol intake and incident depression: the SUN project. BMC Public Health. 2012 Nov 7;12:954. doi: 10.1186/1471-2458-12-954.
- Results publication: PubMed 12571653Rosell M, De Faire U, Hellenius ML. Low prevalence of the metabolic syndrome in wine drinkers--is it the alcohol beverage or the lifestyle? Eur J Clin Nutr. 2003 Feb;57(2):227-34. doi: 10.1038/sj.ejcn.1601548.
- Results publication: PubMed 28602493Scrimgeour LA, Potz BA, Elmadhun NY, Chu LM, Sellke FW. Alcohol attenuates myocardial ischemic injury. Surgery. 2017 Sep;162(3):680-687. doi: 10.1016/j.surg.2017.04.014. Epub 2017 Jun 9.
- Results publication: PubMed 22229788Roerecke M, Rehm J. The cardioprotective association of average alcohol consumption and ischaemic heart disease: a systematic review and meta-analysis. Addiction. 2012 Jul;107(7):1246-60. doi: 10.1111/j.1360-0443.2012.03780.x. Epub 2012 Mar 21.
- Results publication: PubMed 25925415Cosmi F, Di Giulio P, Masson S, Finzi A, Marfisi RM, Cosmi D, Scarano M, Tognoni G, Maggioni AP, Porcu M, Boni S, Cutrupi G, Tavazzi L, Latini R; GISSI-HF Investigators. Regular wine consumption in chronic heart failure: impact on outcomes, quality of life, and circulating biomarkers. Circ Heart Fail. 2015 May;8(3):428-37. doi: 10.1161/CIRCHEARTFAILURE.114.002091. Epub 2015 Apr 29.
- Results publication: PubMed 26797806Gonzalez-Rubio E, San Mauro I, Lopez-Ruiz C, Diaz-Prieto LE, Marcos A, Nova E. Relationship of moderate alcohol intake and type of beverage with health behaviors and quality of life in elderly subjects. Qual Life Res. 2016 Aug;25(8):1931-42. doi: 10.1007/s11136-016-1229-2. Epub 2016 Jan 21.
- Results publication: PubMed 11493125Mortensen EL, Jensen HH, Sanders SA, Reinisch JM. Better psychological functioning and higher social status may largely explain the apparent health benefits of wine: a study of wine and beer drinking in young Danish adults. Arch Intern Med. 2001 Aug 13-27;161(15):1844-8. doi: 10.1001/archinte.161.15.1844.
- Individual participant dataSharing planned: Undecided
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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. 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 red wine in people with Quality of Life, run by IRCCS San Raffaele at 1 site in Italy.
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 11 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 22 Jul 2025. 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 Italy. 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?
Number of participants consuming red wine after surgery showing improved health perception status assessed with the Mental Health Index (MHI) of the Short Form-36 Health Survey questionnaire (time frame: 30 days). 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 NCT05261620, which also lists 42 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 22 Jul 2025.