Bioavailability of Red Wine Anthocyanins

November 23, 2016 updated by: Universidade do Porto

Bioavailability of Table Red Wine and Young Port Red Wine Anthocyanins

The main aim of this study is to evaluate the bioavailability of table red wine and young Port red wine anthocyanins in healthy men.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anthocyanins (ANT) are water soluble pigments found in plants, flowers and fruits that are consumed as part of the human diet, many times in higher amounts than other flavonoid classes. Red wine is also an important source of anthocyanins, especially Mv3glc.

Several epidemiological studies have suggested that the consumption of anthocyanin-rich foods, including the moderate consumption of red wine, is positively associated with the prevention of cardiovascular heart disease.

It has become clear that the flavonoid bioactive forms in vivo are not necessarily those which occur in nature, but metabolites arising after absorption takes place.Therefore, studying the bioavailability of red wine ANT is very important to identify which metabolites (originated in vivo) can actually reach the target organs (and in which concentrations) and may be responsible for the postulated health benefits of red wine.

Intervention protocol:

Urine samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting subjects. Afterwards, each volunteer will consume 250 ml of table red wine or 150 ml of young Port red wine and blood samples will be collected 15, 30, 60 and 120 min after wines ingestion. Another urine sample will be collected at 120 min.

Table red wine 12 % (250 ml) and young Port red wine 20 % (150 ml), two different food matrices rich in ANT, provided the same amount of ethanol (24 g of ethanol).

A thorough screening analysis for ANT will be performed in plasma and urine samples collected from the volunteers at different time points.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4200-450
        • CINTESIS - Faculty of Medicine of the University of Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men
  • Age 18-65 years
  • BMI < 25 kg/m2
  • Willing and able to provide written consent

Exclusion Criteria:

  • Subjects with current or previous CVD, diabetes or other severe chronic disease
  • Subjects under prescription of any chronic medication
  • Intake of red fruits or red wine in the last 24 h prior to the beginning of the intervention
  • Subjects involved in any clinical or food study within the preceding month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Table Red Wine
250 ml Table Red Wine (12% ethanol)
Dietary supplement: Table Red Wine
Experimental: Young Port Red Wine
150 ml Young Port Red Wine (20% ethanol)
Dietary supplement: Young Port Red Wine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentrations of anthocyanins and anthocyanins metabolites
Time Frame: At baseline and 15, 30, 60 and 120 minutes after wines consumption
At baseline and 15, 30, 60 and 120 minutes after wines consumption

Secondary Outcome Measures

Outcome Measure
Time Frame
Urinary concentrations of anthocyanins and anthocyanins metabolites
Time Frame: At baseline and 120 minutes after wines consumption
At baseline and 120 minutes after wines consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

Center for Health Technology and Services Research
REQUIMTE/LAQV, Departamento de Química e Bioquímica, FCUP
Vinoflavo

Investigators

  • Principal Investigator: Conceição Calhau, PhD, CINTESIS - Faculty of Medicine of University of Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VINOFLAVO_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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