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 |
| Secondary identifying numbers | 1-9-2010 |
- 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
Scientific
Olomouc University Hospital
First Clinic Of Internal Medicine
I. P. Pavlova 6
Olomouc
77520
Czech Republic
| Phone | +420 588 442 211 |
|---|---|
| milos.taborsky@seznam.cz |
Study information
| Study design | Long term prospective multicentre randomised parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact Ms Dagmar Strnkova [dagmar.strnkova@fnol.cz] to request a patient 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 | 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 study start date | 01/12/2010 |
| Completion date | 01/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
77520
Czech Republic
Sponsor information
Olomouc University Hospital (Czech Republic)
Hospital/treatment centre
Hospital/treatment centre
First Clinic of Internal Medicine
I. P. Pavlova 6
Olomouc
77520
Czech Republic
| Phone | +420 588 443 716 |
|---|---|
| milos.taborsky@seznam.cz | |
"ROR" |
https://ror.org/01jxtne23 |
Funders
Funder type
Hospital/treatment centre
Olomouc University Hospital (Czech Republic)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
