Contact information
Type
Scientific
Primary contact
Dr Jeremy Paul Edward Spencer
ORCID ID
Contact details
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
+44 (0)118 378 8724
j.p.e.spencer@reading.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00937313
Protocol/serial number
N/A
Study information
Scientific title
The pharmacokinetics and potential health effects of champagne wine in human subjects: a placebo-controlled randomised cross-over human trial
Acronym
Study hypothesis
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
The University of Reading Research Ethics Committee approved on the 8th May 2007 (ref: 07/16)
Study design
Placebo-controlled randomised cross-over human trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
01/09/2008
Overall trial end date
01/08/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15
Participant 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
Recruitment start date
01/09/2008
Recruitment end date
01/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Food and Nutritional Sciences
Reading
RG6 6AP
United Kingdom
Sponsor information
Organisation
Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
Sponsor details
Polaris House
North Star Avenue
Swindon
SN2 1UH
United Kingdom
+44 (0)1793 413200
external.relations@bbsrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Biotechnology and Biological Sciences Research Council (BBSRC) (UK) (ref: BB/F008953/1; BB/C518222/1; BB/G005702/1)
Alternative name(s)
BBSRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19943984
Publication citations
-
Results
Vauzour D, Houseman EJ, George TW, Corona G, Garnotel R, Jackson KG, Sellier C, Gillery P, Kennedy OB, Lovegrove JA, Spencer JP, Moderate Champagne consumption promotes an acute improvement in acute endothelial-independent vascular function in healthy human volunteers., Br. J. Nutr., 2010, 103, 8, 1168-1178, doi: 10.1017/S0007114509992959.