Pharmacokinetics Assessing Bioavailability of Gingerols and Shogaols of Five Ginger Extracts

NCT03698318 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-01-11

No results posted yet for this study

Summary

The objective of this study is to assess bioavailability of total gingeroids, free gingerols and shogaols, so as their glucuronide and sulfate metabolites, in the plasma, after consumption of a single dose of 5 different ginger extracts. These five extracts have the same quantity of active substance but with different titration (1.6%, 5%, 39%, 26% and 26% NOP80).

Conditions

  • Healthy Subject

Interventions

DIETARY_SUPPLEMENT

Tested product n°1

1 capsule (26% of gingerol/shogaol in 100 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)

DIETARY_SUPPLEMENT

Tested product n°2

1 capsule (38.6% of gingerol/shogaol in 74.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)

DIETARY_SUPPLEMENT

Tested product n°3

2 capsules (6.8% of gingerol/shogaol in 424.3 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)

DIETARY_SUPPLEMENT

Tested product n°4

1 capsule (27% of gingerol/shogaol in 104.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)

DIETARY_SUPPLEMENT

Tested product n°5

6 capsules (1.6% of gingerol/shogaol in 1806.25 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)

Sponsors & Collaborators

  • Biofortis Mérieux NutriSciences

    collaborator OTHER
  • Givaudan France Naturals

    lead INDUSTRY

Principal Investigators

  • Romain Le Cozannet, PhD · Givaudan France Naturals

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2018-12-07
Completion
2018-12-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03698318 on ClinicalTrials.gov