Status:
COMPLETED
Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Top Institute Food and Nutrition
Conditions:
Endothelial Dysfunction
Bioavailability
Eligibility:
MALE
40-80 years
Phase:
NA
Brief Summary
Intervention studies support a protective effect of flavonoid-rich foods such as chocolate and tea on cardiovascular disease risk. In a previous study we found that pure epicatechin improves markers o...
Detailed Description
Twenty male participants between the ages of 40 and 80 will visit the university on three days, separated by a 2-week washout. During each visit the participants will, in random order, be allocated to...
Eligibility Criteria
Inclusion
- Age between 40 and 80 years,
- BMI between \> 20 and ≤ 30
- 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, GGT), serum glucose and HDL, LDL and total cholesterol.
Exclusion
- 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 greater than or equal to 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)
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02221791
Start Date
June 1 2014
End Date
October 1 2014
Last Update
October 15 2014
Active Locations (1)
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1
Wageningen University
Wageningen, Netherlands, 6703 HD