The pharmacokinetics and potential health effects of champagne wine in human subjects

ISRCTN	ISRCTN38867650
DOI	https://doi.org/10.1186/ISRCTN38867650
ClinicalTrials.gov (NCT)	NCT00937313
Protocol serial number	N/A
Sponsor	Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
Funder	Biotechnology and Biological Sciences Research Council (BBSRC) (UK) (ref: BB/F008953/1; BB/C518222/1; BB/G005702/1)

Submission date: 09/07/2009
Registration date: 07/08/2009
Last edited: 31/01/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jeremy Paul Edward Spencer
Scientific

Department of Food and Nutritional Sciences
School of Chemistry, Food Biosciences and Pharmacy
The University of Reading
PO Box 226, Whiteknights
Reading
RG6 6AP
United Kingdom

Phone	+44 (0)118 378 8724
Email	j.p.e.spencer@reading.ac.uk

Study information

Primary study design	Interventional
Study design	Placebo-controlled randomised cross-over human trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The pharmacokinetics and potential health effects of champagne wine in human subjects: a placebo-controlled randomised cross-over human trial
Study objectives	Determine whether there is a link between champagne wine intake and changes in cardiovascular disease (CVD) risk factors, including blood lipid profile, platelet function and oxidative status. The study will also establish the absorption of polyphenol uptake following consumption of champagne wine.
Ethics approval(s)	The University of Reading Research Ethics Committee approved on the 8th May 2007 (ref: 07/16)
Health condition(s) or problem(s) studied	Cardiovascular disease (CVD) risk factors
Intervention	Acute consumption of three glasses of champagne wine (375 ml) or the equivalent alcohol with sparkling mineral water as the control (placebo) within a 10-minute period. This amount of champagne contains 4.5 units of alcohol, which is above the legal limit for operating a car or other machinery. 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. 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. The intervention was then performed. 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-hour 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-hour and 32-hour blood and urine samples.
Intervention type	Other
Primary outcome measure(s)	1. Assessment of endothelial function by Laser Doppler Imaging with iontophoresis, at baseline and 28 days 2. Blood assessment of lipid profile, inflammatory markers, plasma antioxidant and oxidant capacity, liver enzyme and metalloproteinase blood concentrations, measured at baseline, 15, 30, 45, 60, 120, 180, 240, 300, 360 and 480 minutes post-consumption at each intervention point
Key secondary outcome measure(s)	Bioavailability of phytochemicals and metabolite excretion, pooled urine samples were collected over 3 x 8-hour periods, at 24 hours and 32 hours at each intervention point
Completion date	01/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	15
Key inclusion criteria	1. Healthy male and female subjects 2. Aged between 20 and 65 years 3. Body mass index (BMI) between 19 and 25 kg/m^2 4. Normal concentrations of liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [gamma-GT]) 5. Normal haemoglobin, hematocrit and leucocyte counts 6. Absence of glucose and protein in urine
Key exclusion criteria	1. Diabetes mellitus 2. Any form of liver or gastrointestinal disorder 3. Low body mass index [BMI] (less than 19 kg/m^2) 4. High blood pressure (greater than 150/90 mmHg) 5. Anaemia 6. Gall bladder problems 7. Present illness 8. Taking dietary supplements 9. Vigorous exercise (greater than 3 x 20 minutes/week) 10. Alcohol consumption more than 120 g (women) and 168 g (men) per week 11. Pregnant or lactating females
Date of first enrolment	01/09/2008
Date of final enrolment	01/08/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Food and Nutritional Sciences

Reading
RG6 6AP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes