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

NCT ID: NCT00937313

Last Updated: 2009-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-09-30

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.

Conditions

No Condition. Assessment of Healthy Volunteers.

Study Groups

Champagne wine

Champagne wine intervention

Intervention Type: OTHER

Placebo-controlled randomised cross-over human trial

Placebo

alcohol with sparkling mineral water

Champagne wine intervention

Intervention Type: OTHER

Placebo-controlled randomised cross-over human trial

Interventions

Champagne wine intervention

Placebo-controlled randomised cross-over human trial

Intervention Type: OTHER

Other Intervention Names

Non applicable

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Reading

OTHER

Sponsor Role: lead

Responsible Party

Department of Food and Nutritional Sciences

Principal Investigators

Jeremy PE Spencer, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Reading

David Vauzour, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Reading

Julie Lovegrove, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Reading

Locations

Department of Food and Nutritional Sciences

Reading, Berkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

UoR 07/16

Identifier Type: -

Identifier Source: org_study_id