Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Functio
- Conditions
- endothelial functionVascular function10057166
- Registration Number
- NL-OMON41113
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- Age between 40 and 80 years
- BMI > 20 and <= 30
- Apparently healthy (no reported current or previous metabolic diseases, no history of cardiovascular diseases, no history of renal, liver or thyroid diseases, no history of gastrointestinal diseases, no diagnosed diabetes mellitus, fasting laboratory parameters within normal range as judged by the study physician: renal function (serum creatinine, ureum), liver function (ALAT, ASAT, *-GT), serum glucose and HDL, LDL and total cholesterol.
• Body mass index >30 or <=20 kg/m2
• Usage of CVD medication (e.g. anti-hypertensive and/or lipid-modifying medication, non-steroidal anti-inflammatory drugs, acetylsalicylic acid), antibiotics, corticosteroids or opioids and not able or willing to stop taking them from at least 4 weeks prior to the study
• Taking nutritional supplements and unwilling to discontinue
• Reported dietary habits: medically prescribed diet, slimming diet;
• Reported average alcohol consumption >= 3 glasses/d
• Reported intense sporting activities > 10 h/w
• Weight loss or weight gain of 5 kg or more during the last 2 months
• Smokers
• Vegetarians
• Problems with consuming the supplements or following the study guidelines
• Recent blood donation (i.e. 1 month) prior to the study and/or planned donation during and shortly after the study period
• Not agreeing to be informed about unexpected and medically relevant personal test-results, or not agreeing that their general practitioner will be informed about these results
• Participation in another biomedical trial less than 2 months before the start of the study or at the same time
• No signed informed consent form
• Unable to comply with the study procedure (e.g. holidays, urine collection, blood sampling)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the acute response in Flow-Mediated Dilation (FMD) as a<br /><br>marker of vascular function. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcomes are:<br /><br><br /><br>- plasma and urine epicatechin concentrations<br /><br>- pulse wave analysis<br /><br>- plasma nitric oxide and endothelin-1 concentrations</p><br>