Clinical Trials Directory

Trials / Completed

CompletedNCT00937313

The Pharmacokinetics and Potential Health Effects of Champagne Wine in Human Subjects

Status
Completed
Phase
Study type
Observational
Enrollment
15 (actual)
Sponsor
University of Reading · Academic / Other
Sex
All
Age
20 Years – 65 Years
Healthy volunteers
Accepted

Summary

* To assess whether acute, moderate Champagne wine consumption modulates endothelial function in healthy human volunteers. * To establish the bioavailability of Champagne wine polyphenols and their metabolism.

Detailed description

Subjects refrained from consuming high polyphenol foods for 48 h prior to the start of the study and for 32 h post initiation. In particular, the following foods and beverages were excluded from volunteer diets: cocoa containing products, coffee, tea and wine. The study was designed as a single blind, randomized, crossover intervention trial, where volunteers were asked to consume either 375 ml of Champagne wine or a placebo matched for alcohol content, sugars and fruit-derived acids. Subjects were assessed for anthropometric measurements and provided a urine sample prior baseline Laser Doppler Imaging with iontophoresis (LDI) measurements. Subjects were then cannulated and a baseline blood sample was collected. Subjects were then randomly assigned to either the Champagne wine or placebo group and asked to consume the beverage within a 10 min period. Following a standardised breakfast blood samples were collected at: 15, 30, 45, 60, 120, 180, 240, 300, 360 and 480 minutes post consumption and pooled urine samples were collected over 3 x 8 h periods. A standardised breakfast and lunch were also consumed at 15 and 200 minutes post beverage. LDI measurements were carried out at 120, 240, 360 and 480 minutes. Subjects also provided 24 h and 32 h blood and urine samples. Following a washout period of 28 days, volunteers returned to the unit to complete the second arm of the study where the procedure above was repeated.

Conditions

Interventions

TypeNameDescription
OTHERChampagne wine interventionPlacebo-controlled randomised cross-over human trial

Timeline

Start date
2007-07-01
Primary completion
2008-02-01
Completion
2008-09-01
First posted
2009-07-13
Last updated
2009-07-13

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT00937313. Inclusion in this directory is not an endorsement.