The Pharmacokinetics and Potential Health Effects of Champagne Wine in Human Subjects
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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 |
- 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 ]
- 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 |
Healthy volunteers
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| United Kingdom | |
| Department of Food and Nutritional Sciences | |
| Reading, Berkshire, United Kingdom, RG6 6AP | |
| 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 June 18, 2013