Pharmacokinetic study to assess the bioavailability of the cocoa flavanols catechin and epicatechin from different matrices.

Cocoa and chocolate products have generated significant interest due to their
association with various health-protective and therapeutic activities. Cocoa
and chocolate are rich sources of flavan-3-ols, which are present in monomeric
and polymeric forms. Although the concentration of specific flavan-3-ol species
in cocoa and chocolate varies greatly depending on the raw material, the type
of processing, and the nature of the finished product, monomers are one of the
predominant forms present. Major monomeric flavan-3-ols present in cocoa and
chocolate include (+)-catechin and (-)-catechin and (-)-epicatechin. Many of
the proposed health-protective activities associated with the consumption of
cocoa and chocolate have been attributed to such flavan-3-ols, including
monomers. Interest in these activities has resulted in the need to better
understand the bioavailability of flavan-3-ol monomers, especially when
consumed at levels reasonably found in commercial cocoa matrices. Due to the
fact that the net absorption and resulting circulating levels of flavan-3-ols
are regarded to be generally low, designing matrices to optimize the
flavan-3-ol bioavailability resulting from cocoa consumption could prove to be
an important strategy for maximizing the in vivo health benefits from cocoa
products.

The objective of the study is to assess the impact of the physical form of five
different cocoa matrices on the bioavailability of the monomeric flavan-3-ols.
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.

Blinded, randomized, placebo-controlled cross-over studie with 6 subjects.

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.

The risk for the volunteers is considerd negligible. The study comprises around
5 weeks and in total 31 venous blood samples are taken (a total of 515 mL
blood) using 1 venapunction and 5 peripheral intravenous catheters. The trial
comprises of 6 site visits. Vounteers will not benefit directly from
participation.