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CompletedNCT01230281C3GUpdated Dec 14, 2010

A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract

An interventional study of Black bean seed coat extract in Oxidative Stress, sponsored by Seoul St. Mary's Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-14.

Sponsored by Seoul St. Mary's Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured.

Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg black bean seed coat extract.

This study, as an exploratory trial, does not required statistical hypothesis

02

Conditions studied

  • Oxidative Stress

Keywords

  • C3G
  • Oxidative stress
  • Antioxidant
  • Black bean
03

In context

Lead sponsor

Seoul St. Mary's Hospital is the lead sponsor of 71 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body weight >55 kg for male, >45 kg for female (within 80-120% of Ideal body weight)
  • Give written informed consent and voluntarily decide participation

Exclusion criteria

Exclusion Criteria:

  • Acute or chronic disease symptom on screening
  • Existing active and clinically significant disease involving more than one organ system
  • Known allergy to Mulberry or other berries
  • Positive drug or alcohol screening
  • Smokers of 10 or more cigarettes per day
  • Participation in a clinical trial during last 2 month prior to the start of the study
  • Pregnancy
05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Black bean seed coat extract

    Daily 1000 mg oral Black bean seed coat extract is given to each subject for 2 weeks from Day2 after measuring antioxidative marker without intervention on Day1.

    Other: Black bean seed coat extract

Interventions

  • OtherBlack bean seed coat extract

    1000 mg oral daily dose for 2 weeks

06

What researchers measure

Primary outcomes

  1. Cmax - Maximum Observed Concentration - C3G in Plasma

    Time frame: Blood samples collected over 6 hours

  2. AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma

    Time frame: Blood samples collected over 6 hours

  3. Antioxidative markers

    Time frame: 2 weeks

Secondary outcomes

  1. Number of Participants with Adverse Events

    Time frame: for 4 weeks

07

Study locations

1 site
  • Seoul St.Mary's Hospital
    Seoul, 137-701, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01230281
Lead sponsor
Seoul St. Mary's Hospital
Collaborators
Rural Development Administration, Korea
First posted
Oct 29, 2010
Start date
Nov 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Dec 14, 2010

Study contacts

Dong-Seok Yim, M.D., PhD.
principal investigator · Seoul St. Mary's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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