Condition category
Not Applicable
Date applied
30/06/2014
Date assigned
06/08/2014
Last edited
06/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rosa María Lamuela Raventos

ORCID ID

Contact details

Food Science Department
Pharmacy Faculty
University of Barcelona
Av/ Joan XXIII S/N
Barcelona
08028
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRB00003099

Study information

Scientific title

Bioavailability of polyphenols from wine and dealcoholized wine: a cross-over, randomized and double blind trial

Acronym

BIOPOLIAL

Study hypothesis

Wine contains several phenolic compounds, which are known for their health benefits.
Hypothesis 1: Ethanol increases the bioavailability of phenolic compounds

Ethics approval

Ethics Committee of University of Barcelona, 06/03/2014, Institutional Review Board IRB00003099

Study design

Cross-over randomized double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 (LC–MS/MS)

Secondary outcome measures

N/A

Overall trial start date

15/03/2014

Overall trial end date

15/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy adult males, aged 20-40 years

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

20

Participant 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

Recruitment start date

15/03/2014

Recruitment end date

15/11/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Food Science Department
Barcelona
08028
Spain

Sponsor information

Organisation

Ministry of Economy and Competitiveness – INNPRONTA (Miguel Torres S.A) (Spain)

Sponsor details

C/Miguel Torres 6
Vilafranca del Penedés
Barcelona
08720
Spain

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

Ministry of Economy and Competitiveness – INNPRONTA (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

CIBEROBN (Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición) (Biomedical Research Centre in Physiopathology of Obesity and Nutrition) (Spain)

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