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

This study has been completed.
Sponsor:
Information provided by:
University of Reading
ClinicalTrials.gov Identifier:
NCT00937313
First received: July 10, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 10, 2009
July 10, 2009
July 2007
February 2008   (final data collection date for primary outcome measure)
Assessment of endothelial function by Laser Doppler Imaging with iontophoresis. Blood Assessment of lipid profile, inflammatory markers, plasma antioxidant and oxidant capacity, liver enzyme and metalloproteinase blood concentrations. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Bioavailability of phytochemicals and metabolite excretion. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Pharmacokinetics and Potential Health Effects of Champagne Wine in Human Subjects
The Pharmacokinetics and Potential Health Effects of Champagne Wine in Human Subjects
  • 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.

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.

Observational
Not Provided
Not Provided
Retention:   Samples Without DNA
Description:

plasma serum urine

Probability Sample

Healthy volunteers

No Condition. Assessment of Healthy Volunteers.
Other: Champagne wine intervention
Placebo-controlled randomised cross-over human trial
Other Name: Non applicable
  • Champagne wine
    Intervention: Other: Champagne wine intervention
  • Placebo
    alcohol with sparkling mineral water
    Intervention: Other: Champagne wine intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female subjects, aged between 20 and 65 years, with a Body Mass Index (BMI) between 19 and 25 kg/m². Normal concentrations of liver enzymes (AST, ALT, gamma GT), normal hemoglobin, hematocrit and leucocyte counts and an absence of glucose and protein in urine

Exclusion Criteria:

  • Individuals with diabetes, any form of liver or gastrointestinal disorder, low BMI (<19), high blood pressure (>150/90 mm/Hg), anaemia, gall bladder problems, present illness, or those taking dietary supplements, vigorous exercise (> 3 x 20 min/week), or alcohol consumption more than 120 g (women) and 168 g (men) per week , pregnant or lactating females.
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00937313
UoR 07/16
No
Jeremy Paul Edward Spencer, PhD, Department of Food and Nutritional Sciences
University of Reading
Not Provided
Principal Investigator: Jeremy PE Spencer, PhD The University of Reading
Principal Investigator: David Vauzour, PhD The University of Reading
Principal Investigator: Julie Lovegrove, PhD The University of Reading
University of Reading
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP