Dose dependent acute effects of decaffeinated coffee on endothelial function and glucose metabolism in healthy volunteers
Completed
- Conditions
- Cardiovascular and metabolic diseases/ clinical nutritionNutritional, Metabolic, EndocrineN/A
- Registration Number
- ISRCTN41583899
- Lead Sponsor
- niversity of Palermo (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
1. Male and female healthy subjects
2. Range of age: 25-50 years
3. Range of body mass index (BMI): 20-28 kg/m^2
Exclusion Criteria
1. Any metabolic, cardiovascular or systemic disease
2. Any drug treatment
3. Smoking habits
4. Pregnancy or lactation in the last six months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Fasting acute effects of the two different doses of coffee on endothelial function, measured as the flow mediated dilation (FMD). FMD measurements (outcome assessors blinded) will be performed before, 30 and 60 minutes after coffee ingestion.<br>2. Fasting acute effects of the two different doses of coffee on glucose metabolism, evaluated on the basis of blood concentrations of glucose, insulin and c-peptide. These blood measurements will be obtained before and 60 minutes after coffee ingestion.
- Secondary Outcome Measures
Name Time Method 1. Blood pressure, obtained before, 30 and 60 minutes after coffee ingestion <br>2. Heart rate, measured continuously for the entire duration of the test (60 min) <br>3. Electrocardiogram with QTc interval measurement, obtained before and 60 minutes after coffee ingestion <br>4. A blood sample will be collected before and 60 minutes after coffee ingestion in both occasions and the serum samples will be frozen at -80°C for future measurements (Interleukin-6 [IL-6], tumour necrosis factor-alpha [TNF-alpha], etc.)