Wine Implementation for Surgical Recovery Enhancement

Quality of Life Clinical Trial

— WISE  

Official title:

W.I.S.E.-Wine Implementation for Surgical Recovery Enhancement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05261620
• Other study ID #: WISE trial
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: December 12, 2024

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: Umberto Capitanio
• Phone: 3492503788
• Email: capitanio.umberto[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 the toxicity related to the surgery.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 12, 2024
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
Italy	Umberto Capitanio	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	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	30 days
Secondary	Number of Participants consuming red wine experiencing hospital readmissions after surgery	Rate of hospital readmissions from surgery	30 days
Secondary	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	30 days
Secondary	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.	30 days