Condition category
Circulatory System
Date applied
09/07/2009
Date assigned
07/08/2009
Last edited
31/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bbsrc.ac.uk/index.html

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

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes