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Completed

NCT Number: NCT02975856

Bioavailability of 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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CINTESIS - Faculty of Medicine of the University of Porto

Porto, 4200-450, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Table Red Wine

Dietary Supplement

Young Port Red Wine

Dietary Supplement

Primary outcomes

  1. Plasma concentrations of anthocyanins and anthocyanins metabolites

    Time frame: At baseline and 15, 30, 60 and 120 minutes after wines consumption

Secondary outcomes

  1. Urinary concentrations of anthocyanins and anthocyanins metabolites

    Time frame: At baseline and 120 minutes after wines consumption

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

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

Registry information

Official study title

Bioavailability of Table Red Wine and Young Port Red Wine Anthocyanins

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 29, 2016
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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