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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014