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

ISRCTN	ISRCTN54359610
DOI	https://doi.org/10.1186/ISRCTN54359610
Protocol serial number	1-9-2010
Sponsor	Olomouc University Hospital (Czech Republic)
Funder	Olomouc University Hospital (Czech Republic)

Submission date: 05/11/2010
Registration date: 20/12/2010
Last edited: 20/12/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Milos Taborsky
Scientific

Olomouc University Hospital
First Clinic Of Internal Medicine
I. P. Pavlova 6
Olomouc
77520
Czech Republic

Phone	+420 588 442 211
Email	milos.taborsky@seznam.cz

Study information

Primary study design	Interventional
Study design	Long term prospective multicentre randomised parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	IVV
Study objectives	Regular consumption of Moravian wine will improve the profile of laboratory parameters associated with the development of atherosclerosis.
Ethics approval(s)	The Ethics Committee of University Hospital Olomouc approved on the 16th November 2009 (ref: 124/09)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Level of high density lipoprotein (HDL) cholesterol, measured at 6 and 12 months.
Key secondary outcome measure(s)	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.
Completion date	01/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Age over 18 years 2. No symptoms of atherosclerosis 3. Mild to moderate risk of cardiovascular disease
Key exclusion criteria	1. Acute or chronic inflammatory disease 2. Liver disease 3. Renal disease
Date of first enrolment	01/12/2010
Date of final enrolment	01/12/2012

Locations

Countries of recruitment

Czech Republic

Study participating centre

Olomouc University Hospital

Olomouc
77520
Czech Republic

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes