Absorption, Metabolism and Excretion of Dietary Polyphenolic Bioactives in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      The objectives of this study are to i) describe the absorption, distribution, metabolism and
      excretion (ADME) and pharmacokinetic parameters of selected dietary (poly)phenols in humans;
      and ii) to compare the ADME and pharmacokinetic parameters of selected dietary (poly)phenols
      in humans.
    

Detailed description: 
      Dietary (poly)phenols are a large group of bioactive food constituents that can be classified
      in flavonoids, stilbenes, lignans and phenolic acids. Flavonoids can be subclassified in
      different subgroups, including but not limited to flavanols (e.g. (-)-epicatechin,
      (+)-catechin, procyanidins, EGCG, EGC, etc) and flavones (apigenin and luteolin). Examples of
      flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries,
      pomegranate and nuts. Examples of flavone-containing foods and beverages are parsley, celery,
      and chamomile.

      (Poly)phenolic bioactives are actively investigated for their putative beneficial health
      effects in humans. In this context, understanding the ADME of dietary (poly)phenols is
      recognized as a key step to gain insight into the nutritional and biomedical relevance of
      this group of compounds. Understanding the ADME of polyphenols may aid towards i) the
      identification of metabolites as potential nutritional biomarkers of (poly)phenol
      consumption, ii) the identification of potential active metabolites mediating the effects
      observed after (poly)phenol intake, and iii) the design and execution of dietary intervention
      studies aiming at assess safety and efficacy of (poly)phenols.

      Over the last years, significant progress has been made on the description of the ADME of
      certain (poly)phenols. The investigators recently described the ADME of (-)-epicatechin.
      However, there is still need to understand the ADME of other polyphenolic bioactives as well
      as the importance of the role of the gut microbiome in the metabolism of these compounds. In
      this context, the investigators aim at describing and comparing the ADME of dietary
      polyphenolic bioactives in humans. To accomplish this, the investigators propose conducting a
      randomized, double-masked and cross-over dietary intervention study in healthy young adult
      males. The investigators will evaluate the concentration of polyphenol-derived metabolites in
      plasma and urine after single acute intakes of polyphenol-containing test materials on 8
      different test days.
    

Intervention name(s): Thearubigins; Theaflavins; Procyanidin Dimer B2 (DB2); (-)-Epigallocatechin-3-O-gallate (EGCG); (-)-Epicatechin-3-O-gallate (ECG); (-)-Epicatechin (EC); (-)-Epigallocatechin (EGC); Control
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Single oral intake of 94.9 mg of therubigins (isolated from black tea) in a flavanol-free, fruit flavored, non-dairy drink; Single oral intake of 120 µmol of an equimolar mixture of theaflavins (isolated from black tea) in a flavanol-free, fruit flavored, non-dairy drink. The theaflavin mix includes theaflavin, theaflavin-3-gallate and theaflavin-3,3'-gallate; Single oral intake of 120 µmol of Procyanidin Dimer B2 (DB2) (isolated from Theobroma cacao) in a flavanol-free, fruit flavored, non-dairy drink.; Single oral intake of 120 µmol of (-)-Epigallocatechin-3-O-gallate (EGCG)(isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.; Single oral intake of 120 µmol of (-)-Epicatechin-3-O-gallate (ECG) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.; Single oral intake of 120 µmol of (-)-Epicatechin (EC) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.; Single oral intake of 120 µmol of (-)-Epigallocatechin (EGC) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.; Single oral intake of a flavanol-free, fruit flavored, non-dairy drink.
Intervention MeSH terms: Proanthocyanidin; Epicatechin gallate; Epigallocatechin gallate; Procyanidin; Theaflavin
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: Flavanols; Cocoa Flavanols; Epicatechins; Polyphenols; Procyanidins; EGCG; EGC; ECG; Theaflavins; Thearubigins