Wine Implementation for Surgical Recovery Enhancement (WISE)

March 6, 2024 updated by: Umberto Capitanio, IRCCS San Raffaele

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years-old or older
  • Candidate to surgery
  • Willing to follow the protocol
  • Signed informed consent

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SoC + WISE
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) both for woman and men.
Dietary supplement: red wine
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.
No Intervention: SoC
Control Arm subjects adhere to diet free of any alcohol-containing beverages, as normally recommended by surgeons in their clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants consuming red wine With post-operative complications assessed with Clavien-Dindo classification
Time Frame: 30 days
Rate of post-operative complications according to Clavien-Dindo classification
30 days
Number of Participants consuming red wine experiencing hospital readmissions after surgery
Time Frame: 30 days
Rate of hospital readmissions from surgery
30 days
Number of male Participants consuming red wine with change in sexual perceptions after surgery using IIEF questionnaire
Time Frame: 30 days
To evaluate changes in sexual perceptions after surgery using IIEF questionnaire
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
Oxidative stress will be assessed using ORAC (Oxygen Radical Absorbance Capacity) tests.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Estimated)

December 12, 2024

Study Completion (Estimated)

December 12, 2024

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

February 20, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • WISE trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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