Daily Intake of Cocoa Flavanols and Arterial Stiffness in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      A randomized, double-masked and cross-over dietary intervention study to investigate the
      effects of diet supplementation with cocoa flavanols on arterial stiffness in healthy adult
      human subjects.
    

Detailed description: 
      Cocoa flavanols (CF) are plant-derived compounds commonly present in the human diet. Examples
      of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries,
      pomegranate and nuts. Flavanols encompass a group of different compounds, and the final
      profile of flavanols in foods will depend on multiple factors including plant origin, time of
      harvesting, storage, food processing, and cooking techniques. The term "cocoa flavanols" (CF)
      as used here refers to the particular profile of flavanols and procyanidins naturally found
      in cocoa beans, and CF mainly consist of the monomeric flavanol (-)-epicatechin and its
      oligomeric derivatives (procyanidins) containing up to 10 monomer subunits.

      Accumulating data resulting from dietary intervention studies suggest that the intake of
      diets rich in flavanols can exert a beneficial cardiovascular health effect in humans.
      However, most of these investigations have been conducted with patients with diverse health
      complications (e.g. hypertension, diabetes and coronary heart disease) rather than healthy
      subjects. Thus, the interpretation of these data in the context of nutrition, primary
      prevention, and dietary recommendations is limited. In the current study, the investigators
      propose to investigate the effects of cocoa flavanol intake on arterial stiffness in a
      healthy population of adults. The investigators submit that this investigation will provide
      novel insights into the potential health benefits of dietary flavanols and procyanidins in
      the context of cardiovascular health in humans. The data resulting from this study will be
      key to the design of larger scale studies in this context, which are needed to
      comprehensively study the role of dietary flavanols and procyanidins with regard to potential
      dietary recommendations and public health.
    

Intervention name(s): Cocoa flavanols I; Control I; Cocoa flavanols II; Control II
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks.; Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.; Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks.; Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-masked and cross-over dietary intervention study in healthy adults.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: flavanol; cocoa flavanols; arterial stiffness; blood pressure; step test