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.

Study Overview

• Status: Completed
• Conditions: No Condition. Assessment of Healthy Volunteers.
• Intervention / Treatment: Other: Champagne wine intervention

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AP
      • Department of Food and Nutritional Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy volunteers

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Champagne wine	Other: Champagne wine intervention; Placebo-controlled randomised cross-over human trial; Other Names: Non applicable
Placebo; alcohol with sparkling mineral water	Other: Champagne wine intervention; Placebo-controlled randomised cross-over human trial; Other Names: Non applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Bioavailability of phytochemicals and metabolite excretion.	6 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): July 13, 2009
• Last Update Submitted That Met QC Criteria: July 10, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: UoR 07/16