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
  Purpose
  • 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.

Condition Intervention
No Condition. Assessment of Healthy Volunteers.
Other: Champagne wine intervention

Study Type: Observational
Official Title: The Pharmacokinetics and Potential Health Effects of Champagne Wine in Human Subjects

Further study details as provided by University of Reading:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Bioavailability of phytochemicals and metabolite excretion. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

plasma serum urine


Enrollment: 15
Study Start Date: July 2007
Study Completion Date: September 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Champagne wine Other: Champagne wine intervention
Placebo-controlled randomised cross-over human trial
Other Name: Non applicable
Placebo
alcohol with sparkling mineral water
Other: Champagne wine intervention
Placebo-controlled randomised cross-over human trial
Other Name: Non applicable

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy volunteers

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937313

Locations
United Kingdom
Department of Food and Nutritional Sciences
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Investigators
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
  More Information

No publications provided

Responsible Party: Jeremy Paul Edward Spencer, PhD, Department of Food and Nutritional Sciences
ClinicalTrials.gov Identifier: NCT00937313     History of Changes
Other Study ID Numbers: UoR 07/16
Study First Received: July 10, 2009
Last Updated: July 10, 2009
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on April 16, 2014