Polyphenols bioavailability study on wine
| ISRCTN | ISRCTN74654313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74654313 |
| Secondary identifying numbers | IRB00003099 |
- Submission date
- 30/06/2014
- Registration date
- 06/08/2014
- Last edited
- 06/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Polyphenols are the most abundant antioxidants in the diet and are found in a number of fruit and vegetables. Antioxidants are chemicals that mop up other, damaging, chemicals called free radicals. Free radicals can cause damage to the bodys cells, which can eventually lead to a number of health problems including heart disease and cancer. The effects of polyphenols are dependent on how well they are absorbed (bioavailability) and how they react in, and are used by, the body. Numerous studies have found that people who drink a moderate amount of wine are less likely to have a heart attack or a stroke, among other things. In this study, we aim to find out whether the alcohol (ethanol) in wine increases the bioavailability of polyphenols.
Who can participate?
Healthy men, aged between 20-40 years, non-smokers, without previous history of cardiovascular disease, liver or kidney disease, homeostatic disorders, any several chronic diseases, high blood pressure or dyslipemia (abnormal amount of fat or cholesterol in the body), grape intolerance or allergic, alcoholism or other toxic abuse.
What does the study involve?
Participants are randomly allocated into one of three treatment (intervention) groups. For intervention 1, participants are given 339 mL of water to drink. For intervention 2, they are given 339 mL of wine. For intervention 3, they are given 417 mL of dealcoholized wine. Blood samples are taken at 15 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours and 24 hours after they have had their allotted drink. The first urine of the day before the start of the trial is also collected and then at 0 hours, 0-3 hours, 3-6 hours, 6-12 hours and 12-24 hours the day after they have had their allotted drink. Everyone will participate in all three intervention programmes, but with 3 day rest (wash-out period) in-between, when they are asked not to consume grapes or wine and to follow a polyphenol free diet the day before starting the next treatment.
What are the possible benefits and risks of participating?
There are no direct benefits to taking part in the study and no risks as long as the exclusion criteria are followed.
Where is the study run from?
Department of Nutrition and Food Science of the University of Barcelona (Spain)
When is the study starting and how long is it expected to run for?
March 2014 to November 2014
Who is funding the study?
1. Ministry of Economy and Competitiveness INNPRONTA (Spain)
2. CIBEROBN (Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición) (Biomedical Research Centre in Physiopathology of Obesity and Nutrition) (Spain)
Main contact
Dr. Rosa Lamuela-Raventós,
lamuela@ub.edu
Contact information
Scientific
Food Science Department
Pharmacy Faculty
University of Barcelona
Av/ Joan XXIII S/N
Barcelona
08028
Spain
Study information
| Study design | Cross-over randomized double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Bioavailability of polyphenols from wine and dealcoholized wine: a cross-over, randomized and double blind trial |
| Study acronym | BIOPOLIAL |
| Study objectives | Wine contains several phenolic compounds, which are known for their health benefits. Hypothesis 1: Ethanol increases the bioavailability of phenolic compounds |
| Ethics approval(s) | Ethics Committee of University of Barcelona, 06/03/2014, Institutional Review Board IRB00003099 |
| Health condition(s) or problem(s) studied | Concentration of phenolic metabolites in urine |
| Intervention | Intervention 1: 339 ml of water Intervention 2: 339 ml of wine Intervention 3: 417 ml of dealcoholized wine Before each intervention, participants will follow a 3-day washout period, avoiding consuming grape and wine, and the previous day follow a polyphenol-free diet. Co-sponsor details: CIBEROBN (Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición) (Biomedical Research Centre in Physiopathology of Obesity and Nutrition) (Spain) Instituto de Salud Carlos III C/Monforte de Lemos 3-5 Pabellón 11 Planta 0 28029 Madrid Spain gerencia@ciberisciii.es |
| Intervention type | Other |
| Primary outcome measure | 1. Polyphenols will be identified through liquid chromatography coupled to Orbitrap mass spectrometry 2. Concentrations of polyphenols will be determined by liquid chromatography coupled to tandem mass spectrometry (LCMS/MS) |
| Secondary outcome measures | N/A |
| Overall study start date | 15/03/2014 |
| Completion date | 15/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 20 |
| Key inclusion criteria | Healthy adult males, aged 20-40 years |
| Key exclusion criteria | 1. Previous history of cardiovascular disease (ischemic heart disease - angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease) 2. Homeostatic disorders 3. Any several chronic diseases 4. Hypertension or dyslipidemia 5. Grape intolerance or allergic 6. Smoking subjects 7. Alcoholism 8. Other toxic abuse |
| Date of first enrolment | 15/03/2014 |
| Date of final enrolment | 15/11/2014 |
Locations
Countries of recruitment
- Spain
Study participating centre
08028
Spain
Sponsor information
Government
C/Miguel Torres 6
Vilafranca del Penedés
Barcelona
08720
Spain
Funders
Funder type
Research organisation
No information available
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 |
