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

Completed

• Conditions: No Condition. Assessment of Healthy Volunteers.
• Interventions: Other: Champagne wine intervention

• Registration Number: NCT00937313
• Lead Sponsor: University of Reading

Brief 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.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-02
• Study Completion: 2008-09
• Status Verified: 2009-07
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Last Update Submitted: 2009-07-10
• Study First Posted: 2009-07-13
• Last Update Posted: 2009-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Champagne wine	Champagne wine intervention	-
Placebo	Champagne wine intervention	alcohol with sparkling mineral water

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Bioavailability of phytochemicals and metabolite excretion.	6 months

Trial Locations

Locations (1)

Department of Food and Nutritional Sciences; 🇬🇧 Reading, Berkshire, United Kingdom