Clinical trial NCT00937313: The Pharmacokinetics and Potential Health Effects of Champagne Wine in Human Subjects
Official title: The Pharmacokinetics and Potential Health Effects of Champagne Wine in Human Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: No Condition. Assessment of Healthy Volunteers.
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2009-07-13
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Bioavailability of phytochemicals and metabolite excretion.
timeFrame: 6 months
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences
state: Berkshire
Study officials:
affiliation: The University of Reading
name: Jeremy PE Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Reading
name: David Vauzour, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Reading
name: Julie Lovegrove, PhD
role: PRINCIPAL_INVESTIGATOR
References: