Bioavailability of Red Wine Anthocyanins

Healthy Clinical Trial

Official title:

Bioavailability of Table Red Wine and Young Port Red Wine Anthocyanins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975856
• Other study ID #: VINOFLAVO_02
• Status: Completed
• Phase: Phase 1
• First received: November 23, 2016
• Last updated: November 23, 2016
• Start date: December 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: INFARMED, National Authority of Medicines and Health Products, IP
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Table Red Wine

• Young Port Red Wine

Locations

Country	Name	City	State
Portugal	CINTESIS - Faculty of Medicine of the University of Porto	Porto

Sponsors (5)

Lead Sponsor	Collaborator
Universidade do Porto	Center for Health Technology and Services Research, Faculdade de Medicina, Universidade do Porto, REQUIMTE/LAQV, Departamento de Química e Bioquímica, FCUP, Vinoflavo

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of anthocyanins and anthocyanins metabolites		At baseline and 15, 30, 60 and 120 minutes after wines consumption	No
Secondary	Urinary concentrations of anthocyanins and anthocyanins metabolites		At baseline and 120 minutes after wines consumption	No