Condition category
Circulatory System
Date applied
05/11/2010
Date assigned
20/12/2010
Last edited
20/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Milos Taborsky

ORCID ID

Contact details

Olomouc University Hospital
First Clinic Of Internal Medicine
I. P. Pavlova 6
Olomouc
77520
Czech Republic
+420 588 442 211
milos.taborsky@seznam.cz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1-9-2010

Study information

Scientific title

In Vino Veritas (IVV) a long-term, prospective, multicentre, randomised trial comparing long-term effects of red wine and white wine on the biomarkers of atherosclerosis

Acronym

IVV

Study hypothesis

Regular consumption of Moravian wine will improve the profile of laboratory parameters associated with the development of atherosclerosis.

Ethics approval

The Ethics Committee of University Hospital Olomouc approved on the 16th November 2009 (ref: 124/09)

Study design

Long term prospective multicentre randomised parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact Ms Dagmar Strnkova [dagmar.strnkova@fnol.cz] to request a patient information sheet

Condition

Primary prevention of atherosclerosis in individuals at mild to moderate

Intervention

Eligible individuals will be randomised to regular drinking of either red wine (Pinot Noir, 2008, Moravia, Czech Republic) or white wine (Chardonnay-Pinot, 2008, Moravia, Czech Republic) for 12 months.

1. Women with body with body weight less than 70 kg: 0.2 litre per day
2. Women over 70 kg and men: 0.3 litre per day

Participants will be followed for 12 months on an intention-to-treat basis, and monitored on a continuous basis for 24 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Level of high density lipoprotein (HDL) cholesterol, measured at 6 and 12 months.

Secondary outcome measures

1. Total and low density lipoprotein (LDL) cholesterol
2. Triglycerides
3. Oxidized LDL
4. C-reactive protein (CRP)
4. Advanced oxidation protein product (AOPP)
5. Myeloperoxidase
6. Interleukin 6 (IL-6)
7. IL-18
8. Matrix metalloproteinases
9. Glutathione s-transferase
10. Monocyte chemoattractant protein 1
11. Solube CD40L
12. Fatty acid binding protein

Outcomes will be measured at 6 and 12 months.

Overall trial start date

01/12/2010

Overall trial end date

01/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age over 18 years
2. No symptoms of atherosclerosis
3. Mild to moderate risk of cardiovascular disease

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Acute or chronic inflammatory disease
2. Liver disease
3. Renal disease

Recruitment start date

01/12/2010

Recruitment end date

01/12/2012

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Olomouc University Hospital
Olomouc
77520
Czech Republic

Sponsor information

Organisation

Olomouc University Hospital (Czech Republic)

Sponsor details

First Clinic of Internal Medicine
I. P. Pavlova 6
Olomouc
77520
Czech Republic
+420 588 443 716
milos.taborsky@seznam.cz

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Olomouc University Hospital (Czech Republic)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes