NCT00448513

Brief Summary

The purpose of this study is to clarify the effects of tea catechin extracts on the frequency changes of micronuclei in peripheral lymphocytes compared with other oxidative stress markers in late middle aged healthy volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 16, 2013

Status Verified

April 1, 2009

Enrollment Period

2.2 years

First QC Date

March 16, 2007

Last Update Submit

July 14, 2013

Conditions

Healthy

Keywords

catechinoxidative stresschromosome damageaged

Outcome Measures

Primary Outcomes (1)

  • the frequency changes of micronuclei in peripheral lymphocytes

    After seven days untervention

Secondary Outcomes (1)

  • the change of markers of oxidative damage, as measured by 8-hydroxyguanosine (8-OHdG), vitamin C, folate, homocysteine

    After seven days intervention

Study Arms (1)

catechin

EXPERIMENTAL

catechin capsule group

Dietary Supplement: catechin extracts

Interventions

catechin extractsDIETARY_SUPPLEMENT

comparison with placebo

catechin

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 40 to 65 years old
  • healthy volunteers
  • obtained written informed concent before participation

You may not qualify if:

  • participant who is not able to refrain from drinking tea for 2 weeks during the study
  • participant taking supplements or herbal products including folate, vitamin B, C, E, coenzyme Q10, calcium, for 2 weeks before the study
  • participant taking supplements or herbal products including folate, vitamin E for 3 months before the study
  • participant possessing tea allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shizuoka General Hospital

Shizuoka, Shizuoka, 420-0881, Japan

Location

Study Officials

  • Hiroshi Yamada, MD, PhD

    University of Shizuoka

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2007

First Posted

March 19, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2009

Study Completion

April 1, 2012

Last Updated

July 16, 2013

Record last verified: 2009-04

Locations

JP(1)