The pharmacokinetics and potential health effects of champagne wine in human subjects
- Conditions
- Cardiovascular disease (CVD) risk factorsCirculatory SystemComplications and ill-defined descriptions of heart disease
- Registration Number
- ISRCTN38867650
- Lead Sponsor
- Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Assessment of endothelial function by Laser Doppler Imaging with iontophoresis, at baseline and 28 days<br>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
Name Time Method 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