|- candidate number||9302|
|- NTR Number||NTR2839|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-apr-2011|
|- Secondary IDs||11-3-026 / DRUM11-CACA; MEC azM/UM / DRUM|
|- Public Title||Pharmacokinetic study to assess the bioavailability of the cocoa flavanols catechin and epicatechin from different matrices.|
|- Scientific Title||Pharmacokinetic study to assess the bioavailability of the cocoa flavanols catechin and epicatechin from different matrices.|
|- ACRONYM||Bioavailability of cocoa flevols from different matrices|
|- hypothesis||To assess the impact of the physical form of five different cocoa matrices on the bioavailability of the monomeric flavan-3-ols. |
|- Healt Condition(s) or Problem(s) studied||Chocolate, Cocoa, Flavan-3-ols|
|- Inclusion criteria||1. Adults between 20 and 45 years old;|
2. Non-smoking individuals;
3. Capable and willing to sign the Informed Consent Form at voluntary basis;
4. Considered healthy based on their medical history and physical examination;
5. Female volunteers do not intend to become pregnant prior to or during the study and using adequate contraception.
|- Exclusion criteria||1. Clinically significant abnormal liver biochemistry;|
2. Clinically significant abnormal serum creatinin;
3. Abnormal body mass index;
4. Use of concomitant medications or supplements.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||15-mei-2011|
|- planned closingdate||15-jul-2011|
|- Target number of participants||6|
|- Interventions||Five single doses of a cocoa products in randomised order with a minimal 5-day interval. Four of those cocoa products contain a high level of flavenols and are commercially available. One product is nog commercially available and is only made for clinical trials. This placebo product has exactly the same recipe as the other product, but uses the lowest level of flavenols as possible. |
|- Primary outcome||Area under the blood concentration - time curve (AUC).|
|- Secondary outcome||Maximal blood concentration (Cmax) and time to maximal blood concentration (Tmax).|
|- Timepoints||Blood samples will be collected pre-dose and after 30, 60, 120, 240 and 360 min.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. F. Vanmolkot|
|- CONTACT for SCIENTIFIC QUERIES||Dr. F. Vanmolkot|
|- Sponsor/Initiator ||ProDigest BVBA|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
Cocoa and chocolate products have generated significant interest due to their association with various health-protective and therapeutic activities, into a large extent related to the presence of high amounts of flavan-3-ols such as catechin and epicatechin. However, previous research has also shown that the final bioavailability and biological activity greatly depends on the physical form/matrix in which cocoa is ingested.
The objective of the study is therefore to assess the impact of the physical form and matrix in which they are included, on the bioavailability of the monomeric flavan-3-ols catechin and epicatechin, following consumption of different cocoa formulations.
Double-blinded, randomized, placebo-controlled cross-over study with 6 healthy volunteers. In this study, 5 specific cocoa formulations will be used.
6 healthy, non-smoking adults between 20 and 45 years old.
The study will consist of five separate days with a minimal 5-day washout period in between. Each subject will consume each of the five products once in a crossover design, with a minimal 5-day washout period between samples. The order of the consumption will be randomized for each individual.
Main study parameter:
The aim of the study is to evaluate the effect of the physical form and the composition of cocoa matrices on monomeric flavan-3-ol bioavailability. Assessment and evaluation will be done by comparing the kinetics of the main study parameter: catechin and epicatechin in the serum following a single oral consumption of the cocoa formulation. To do this, blood samples will be collected pre-dose and after 30, 60, 120, 240 and 360 min.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
After an overnight fasting, a catheter is placed in the arm of each subject for repeated blood collection. Per study day, 6 times 16mL blood sample will be taken. The participants are to refrain from high flavan-3-ol containing products for a period starting 2 days prior to the start of each study day. The participants are asked not to change their normal dietary habits during the study period. No adverse effects are expected. Participants will not benefit directly from participation.
|- Main changes (audit trail)|
|- RECORD||4-apr-2011 - 12-sep-2012|