- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975856
Bioavailability of Red Wine Anthocyanins
Bioavailability of Table Red Wine and Young Port Red Wine Anthocyanins
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Porto, Portugal, 4200-450
- CINTESIS - Faculty of Medicine of the University of Porto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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)
|
|
|
Experimental: Young Port Red Wine
150 ml Young Port Red Wine (20% ethanol)
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Conceição Calhau, PhD, CINTESIS - Faculty of Medicine of University of Porto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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