Intake-dependent Effect of Cocoa Flavanol Absorption, Metabolism and Excretion in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      A randomized, double-masked and cross-over dietary intervention study in healthy young adult
      males to evaluate the concentration of F-derived metabolites in plasma and urine after single
      acute intakes of F-containing drinks on four different test days.
    

Detailed description: 
      Flavanols (F) are plant-derived compounds commonly present in the human diet. Examples of
      F-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and
      nuts. The consumption of F-containing foods and beverages has been associated with
      improvements in cardiovascular health. In this context, there exists a great interest in
      describing the absorption, metabolism and excretion of F in humans, as it is thought that
      F-derived metabolites present in circulation are the mediators of F-beneficial effects in
      humans. Recently, we described a series of F-derived metabolites in circulation that are
      present after the consumption of a single acute intake amount of F in humans. A key question,
      however, is if the metabolites we observed after a single acute feeding are the same as those
      that occur in individuals who consume F-rich diets on a regular basis. Studies investigating
      the metabolism of numerous other xenobiotics have shown that the profile of metabolites can
      greatly vary over time, as well as with the amount of xenobiotic ingested. In this context,
      and considering that i) the amount of F-consumed from diet greatly varies among individuals,
      ii) recent epidemiology studies indicate that the vascular protective effects of F diets
      primarily occur when daily intake of F are relatively high; and iii) there is evidence of an
      intake amount-dependency on the vascular effects of F in dietary intervention studies; we
      submit it is important to assess whether or not there are F intake amount-dependent effects
      on the levels and profile of F-derived metabolites in humans. This study will provide new
      information concerning the F-derived metabolites that may be responsible for mediating
      F-beneficial effects in humans. We suggest the information that will be obtained from the
      outlined work will be particularly timely given ongoing discussion concerning the possible
      generation of dietary recommendations for F-rich foods.
    

Intervention name(s): 100 mg of Cocoa Flavanols/70 kg BW; 200 mg of Cocoa Flavanols/70 kg BW; 400 mg of Cocoa Flavanols/70 kg BW; 1000 mg of Cocoa Flavanols/70 kg BW
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Fruit-flavored non-dairy drink containing 100 cocoa flavanols/70kg BW.; Fruit-flavored non-dairy drink containing 200 cocoa flavanols/70kg BW.; Fruit-flavored non-dairy drink containing 400 cocoa flavanols/70kg BW.; Fruit-flavored non-dairy drink containing 1000 cocoa flavanols/70kg BW.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-masked and cross-over dietary intervention study in healthy young adult males
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: flavanol; ADME; cocoa flavanols; polyphenols