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

ISRCTN ISRCTN38867650
DOI https://doi.org/10.1186/ISRCTN38867650
ClinicalTrials.gov number NCT00937313
Secondary identifying numbers N/A
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

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

Study information

Study designPlacebo-controlled randomised cross-over human trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe pharmacokinetics and potential health effects of champagne wine in human subjects: a placebo-controlled randomised cross-over human trial
Study objectivesDetermine 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) studiedCardiovascular disease (CVD) risk factors
InterventionAcute 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 typeOther
Primary outcome measure1. 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 measuresBioavailability 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 study start date01/09/2008
Completion date01/08/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants15
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2008
Date of final enrolment01/08/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Food and Nutritional Sciences
Reading
RG6 6AP
United Kingdom

Sponsor information

Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
Research council

Polaris House
North Star Avenue
Swindon
SN2 1UH
United Kingdom

+44 (0)1793 413200
external.relations@bbsrc.ac.uk
http://www.bbsrc.ac.uk/index.html
ROR logo https://ror.org/00cwqg982

Funders

Funder type

Research council

Biotechnology and Biological Sciences Research Council (BBSRC) (UK) (ref: BB/F008953/1; BB/C518222/1; BB/G005702/1)
Government organisation / National government
Alternative name(s)
UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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