A Phase 1 interventional study of Table Red Wine and Young Port Red Wine in Healthy, sponsored by Universidade do Porto. Completed at 1 site in Portugal. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-29.
Sponsored by Universidade do Porto · Phase 1, Interventional, and Basic science
The main aim of this study is to evaluate the bioavailability of table red wine and young Port red wine anthocyanins in healthy men.
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.
Universidade do Porto is the lead sponsor of 172 studies on the registry; 53 are open to participants now.
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Exclusion Criteria:
250 ml Table Red Wine (12% ethanol)
Dietary Supplement: Table Red Wine
150 ml Young Port Red Wine (20% ethanol)
Dietary Supplement: Young Port Red Wine
Plasma concentrations of anthocyanins and anthocyanins metabolites
Time frame: At baseline and 15, 30, 60 and 120 minutes after wines consumption
Urinary concentrations of anthocyanins and anthocyanins metabolites
Time frame: At baseline and 120 minutes after wines consumption
The record gives a start of Dec 2015, a primary completion of Mar 2016 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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