Absorption, Metabolism and Excretion of Dietary Polyphenolic Bioactives in Humans

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.

Conditions

• Healthy

Interventions

OTHER

Thearubigins

Single oral intake of 94.9 mg of therubigins (isolated from black tea) in a flavanol-free, fruit flavored, non-dairy drink

OTHER

Theaflavins

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

OTHER

Procyanidin Dimer B2 (DB2)

Single oral intake of 120 µmol of Procyanidin Dimer B2 (DB2) (isolated from Theobroma cacao) in a flavanol-free, fruit flavored, non-dairy drink.

OTHER

(-)-Epigallocatechin-3-O-gallate (EGCG)

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.

OTHER

(-)-Epicatechin-3-O-gallate (ECG)

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.

OTHER

(-)-Epicatechin (EC)

Single oral intake of 120 µmol of (-)-Epicatechin (EC) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.

OTHER

(-)-Epigallocatechin (EGC)

Single oral intake of 120 µmol of (-)-Epigallocatechin (EGC) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.

OTHER

Control

Single oral intake of a flavanol-free, fruit flavored, non-dairy drink.

Sponsors & Collaborators

• Mars, Inc.

  collaborator INDUSTRY

• University of California, Davis

  lead OTHER

Principal Investigators

• Carl L Keen, PhD · UC Davis

• Javier I Ottaviani, PhD · Mars, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

25 Years

Max Age

60 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2017-01-12

Completion

2017-01-12

Countries

• United States

Study Locations